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1.  Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD) 
Executive Summary
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.
After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.
The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.
Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework
Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model
Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature
For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm.
For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx.
The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.
Objective
The objective of this evidence-based analysis was to examine the effectiveness, safety, and cost-effectiveness of noninvasive positive pressure ventilation (NPPV) in the following patient populations: patients with acute respiratory failure (ARF) due to acute exacerbations of chronic obstructive pulmonary disease (COPD); weaning of COPD patients from invasive mechanical ventilation (IMV); and prevention of or treatment of recurrent respiratory failure in COPD patients after extubation from IMV.
Clinical Need and Target Population
Acute Hypercapnic Respiratory Failure
Respiratory failure occurs when the respiratory system cannot oxygenate the blood and/or remove carbon dioxide from the blood. It can be either acute or chronic and is classified as either hypoxemic (type I) or hypercapnic (type II) respiratory failure. Acute hypercapnic respiratory failure frequently occurs in COPD patients experiencing acute exacerbations of COPD, so this is the focus of this evidence-based analysis. Hypercapnic respiratory failure occurs due to a decrease in the drive to breathe, typically due to increased work to breathe in COPD patients.
Technology
There are several treatment options for ARF. Usual medical care (UMC) attempts to facilitate adequate oxygenation and treat the cause of the exacerbation, and typically consists of supplemental oxygen, and a variety of medications such as bronchodilators, corticosteroids, and antibiotics. The failure rate of UMC is high and has been estimated to occur in 10% to 50% of cases.
The alternative is mechanical ventilation, either invasive or noninvasive. Invasive mechanical ventilation involves sedating the patient, creating an artificial airway through endotracheal intubation, and attaching the patient to a ventilator. While this provides airway protection and direct access to drain sputum, it can lead to substantial morbidity, including tracheal injuries and ventilator-associated pneumonia (VAP).
While both positive and negative pressure noninvasive ventilation exists, noninvasive negative pressure ventilation such as the iron lung is no longer in use in Ontario. Noninvasive positive pressure ventilation provides ventilatory support through a facial or nasal mask and reduces inspiratory work. Noninvasive positive pressure ventilation can often be used intermittently for short periods of time to treat respiratory failure, which allows patients to continue to eat, drink, talk, and participate in their own treatment decisions. In addition, patients do not require sedation, airway defence mechanisms and swallowing functions are maintained, trauma to the trachea and larynx are avoided, and the risk for VAP is reduced. Common complications are damage to facial and nasal skin, higher incidence of gastric distension with aspiration risk, sleeping disorders, and conjunctivitis. In addition, NPPV does not allow direct access to the airway to drain secretions and requires patients to cooperate, and due to potential discomfort, compliance and tolerance may be low.
In addition to treating ARF, NPPV can be used to wean patients from IMV through the gradual removal of ventilation support until the patient can breathe spontaneously. Five to 30% of patients have difficultly weaning. Tapering levels of ventilatory support to wean patients from IMV can be achieved using IMV or NPPV. The use of NPPV helps to reduce the risk of VAP by shortening the time the patient is intubated.
Following extubation from IMV, ARF may recur, leading to extubation failure and the need for reintubation, which has been associated with increased risk of nosocomial pneumonia and mortality. To avoid these complications, NPPV has been proposed to help prevent ARF recurrence and/or to treat respiratory failure when it recurs, thereby preventing the need for reintubation.
Research Questions
What is the effectiveness, cost-effectiveness, and safety of NPPV for the treatment of acute hypercapnic respiratory failure due to acute exacerbations of COPD compared with
usual medical care, and
invasive mechanical ventilation?
What is the effectiveness, cost-effectiveness, and safety of NPPV compared with IMV in COPD patients after IMV for the following purposes:
weaning COPD patients from IMV,
preventing ARF in COPD patients after extubation from IMV, and
treating ARF in COPD patients after extubation from IMV?
Research Methods
Literature Search
A literature search was performed on December 3, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), Wiley Cochrane, and the Centre for Reviews and Dissemination/International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 2004 until December 3, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Since there were numerous studies that examined the effectiveness of NPPV for the treatment of ARF due to exacerbations of COPD published before 2004, pre-2004 trials which met the inclusion/exclusion criteria for this evidence-based review were identified by hand-searching reference lists of included studies and systematic reviews.
Inclusion Criteria
English language full-reports;
health technology assessments, systematic reviews, meta-analyses, and randomized controlled trials (RCTs);
studies performed exclusively in patients with a diagnosis of COPD or studies performed with patients with a mix of conditions if results are reported for COPD patients separately;
patient population: (Question 1) patients with acute hypercapnic respiratory failure due to an exacerbation of COPD; (Question 2a) COPD patients being weaned from IMV; (Questions 2b and 2c) COPD patients who have been extubated from IMV.
Exclusion Criteria
< 18 years of age
animal studies
duplicate publications
grey literature
studies examining noninvasive negative pressure ventilation
studies comparing modes of ventilation
studies comparing patient-ventilation interfaces
studies examining outcomes not listed below, such as physiologic effects including heart rate, arterial blood gases, and blood pressure
Outcomes of Interest
mortality
intubation rates
length of stay (intensive care unit [ICU] and hospital)
health-related quality of life
breathlessness
duration of mechanical ventilation
weaning failure
complications
NPPV tolerance and compliance
Statistical Methods
When possible, results were pooled using Review Manager 5 Version 5.1, otherwise, the results were summarized descriptively. Dichotomous data were pooled into relative risks using random effects models and continuous data were pooled using weighted mean differences with a random effects model. Analyses using data from RCTs were done using intention-to-treat protocols; P values < 0.05 were considered significant. A priori subgroup analyses were planned for severity of respiratory failure, location of treatment (ICU or hospital ward), and mode of ventilation with additional subgroups as needed based on the literature. Post hoc sample size calculations were performed using STATA 10.1.
Quality of Evidence
The quality of each included study was assessed taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses.
The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence:
Summary of Findings
NPPV for the Treatment of ARF due to Acute Exacerbations of COPD
NPPV Plus Usual Medical Care Versus Usual Medical Care Alone for First Line Treatment
A total of 1,000 participants were included in 11 RCTs1; the sample size ranged from 23 to 342. The mean age of the participants ranged from approximately 60 to 72 years of age. Based on either the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD stage criteria or the mean percent predicted forced expiratory volume in 1 second (FEV1), 4 of the studies included people with severe COPD, and there was inadequate information to classify the remaining 7 studies by COPD severity. The severity of the respiratory failure was classified into 4 categories using the study population mean pH level as follows: mild (pH ≥ 7.35), moderate (7.30 ≤ pH < 7.35), severe (7.25 ≤ pH < 7.30), and very severe (pH < 7.25). Based on these categories, 3 studies included patients with a mild respiratory failure, 3 with moderate respiratory failure, 4 with severe respiratory failure, and 1 with very severe respiratory failure.
The studies were conducted either in the ICU (3 of 11 studies) or general or respiratory wards (8 of 11 studies) in hospitals, with patients in the NPPV group receiving bilevel positive airway pressure (BiPAP) ventilatory support, except in 2 studies, which used pressure support ventilation and volume cycled ventilation, respectively. Patients received ventilation through nasal, facial, or oronasal masks. All studies specified a protocol or schedule for NPPV delivery, but this varied substantially across the studies. For example, some studies restricted the amount of ventilation per day (e.g., 6 hours per day) and the number of days it was offered (e.g., maximum of 3 days); whereas, other studies provided patients with ventilation for as long as they could tolerate it and recommended it for much longer periods of time (e.g., 7 to 10 days). These differences are an important source of clinical heterogeneity between the studies. In addition to NPPV, all patients in the NPPV group also received UMC. Usual medical care varied between the studies, but common medications included supplemental oxygen, bronchodilators, corticosteroids, antibiotics, diuretics, and respiratory stimulators.
The individual quality of the studies ranged. Common methodological issues included lack of blinding and allocation concealment, and small sample sizes.
Need for Endotracheal Intubation
Eleven studies reported the need for endotracheal intubation as an outcome. The pooled results showed a significant reduction in the need for endotracheal intubation in the NPPV plus UMC group compared with the UMC alone group (relative risk [RR], 0.38; 95% confidence interval [CI], 0.28−0.50). When subgrouped by severity of respiratory failure, the results remained significant for the mild, severe, and very severe respiratory failure groups.
GRADE: moderate
Inhospital Mortality
Nine studies reported inhospital mortality as an outcome. The pooled results showed a significant reduction in inhospital mortality in the NPPV plus UMC group compared with the UMC group (RR, 0.53; 95% CI, 0.35−0.81). When subgrouped by severity of respiratory failure, the results remained significant for the moderate and severe respiratory failure groups.
GRADE: moderate
Hospital Length of Stay
Eleven studies reported hospital length of stay (LOS) as an outcome. The pooled results showed a significant decrease in the mean length of stay for the NPPV plus UMC group compared with the UMC alone group (weighted mean difference [WMD], −2.68 days; 95% CI, −4.41 to −0.94 days). When subgrouped by severity of respiratory failure, the results remained significant for the mild, severe, and very severe respiratory failure groups.
GRADE: moderate
Complications
Five studies reported complications. Common complications in the NPPV plus UMC group included pneumonia, gastrointestinal disorders or bleeds, skin abrasions, eye irritation, gastric insufflation, and sepsis. Similar complications were observed in the UMC group including pneumonia, sepsis, gastrointestinal disorders or bleeds, pneumothorax, and complicated endotracheal intubations. Many of the more serious complications in both groups occurred in those patients who required endotracheal intubation. Three of the studies compared complications in the NPPV plus UMC and UMC groups. While the data could not be pooled, overall, the NPPV plus UMC group experienced fewer complications than the UMC group.
GRADE: low
Tolerance/Compliance
Eight studies reported patient tolerance or compliance with NPPV as an outcome. NPPV intolerance ranged from 5% to 29%. NPPV tolerance was generally higher for patients with more severe respiratory failure. Compliance with the NPPV protocol was reported by 2 studies, which showed compliance decreases over time, even over short periods such as 3 days.
NPPV Versus IMV for the Treatment of Patients Who Failed Usual Medical Care
A total of 205 participants were included in 2 studies; the sample sizes of these studies were 49 and 156. The mean age of the patients was 71 to 73 years of age in 1 study, and the median age was 54 to 58 years of age in the second study. Based on either the GOLD COPD stage criteria or the mean percent predicted FEV1, patients in 1 study had very severe COPD. The COPD severity could not be classified in the second study. Both studies had study populations with a mean pH less than 7.23, which was classified as very severe respiratory failure in this analysis. One study enrolled patients with ARF due to acute exacerbations of COPD who had failed medical therapy. The patient population was not clearly defined in the second study, and it was not clear whether they had to have failed medical therapy before entry into the study.
Both studies were conducted in the ICU. Patients in the NPPV group received BiPAP ventilatory support through nasal or full facial masks. Patients in the IMV group received pressure support ventilation.
Common methodological issues included small sample size, lack of blinding, and unclear methods of randomization and allocation concealment. Due to the uncertainty about whether both studies included the same patient population and substantial differences in the direction and significance of the results, the results of the studies were not pooled.
Mortality
Both studies reported ICU mortality. Neither study showed a significant difference in ICU mortality between the NPPV and IMV groups, but 1 study showed a higher mortality rate in the NPPV group (21.7% vs. 11.5%) while the other study showed a lower mortality rate in the NPPV group (5.1% vs. 6.4%). One study reported 1-year mortality and showed a nonsignificant reduction in mortality in the NPPV group compared with the IMV group (26.1% vs. 46.1%).
GRADE: low to very low
Intensive Care Unit Length of Stay
Both studies reported LOS in the ICU. The results were inconsistent. One study showed a statistically significant shorter LOS in the NPPV group compared with the IMV group (5 ± 1.35 days vs. 9.29 ± 3 days; P < 0.001); whereas, the other study showed a nonsignificantly longer LOS in the NPPV group compared with the IMV group (22 ± 19 days vs. 21 ± 20 days; P = 0.86).
GRADE: very low
Duration of Mechanical Ventilation
Both studies reported the duration of mechanical ventilation (including both invasive and noninvasive ventilation). The results were inconsistent. One study showed a statistically significant shorter duration of mechanical ventilation in the NPPV group compared with the IMV group (3.92 ± 1.08 days vs. 7.17 ± 2.22 days; P < 0.001); whereas, the other study showed a nonsignificantly longer duration of mechanical ventilation in the NPPV group compared with the IMV group (16 ± 19 days vs. 15 ± 21 days; P = 0.86). GRADE: very low
Complications
Both studies reported ventilator-associated pneumonia and tracheotomies. Both showed a reduction in ventilator-associated pneumonia in the NPPV group compared with the IMV group, but the results were only significant in 1 study (13% vs. 34.6%, P = 0.07; and 6.4% vs. 37.2%, P < 0.001, respectively). Similarly, both studies showed a reduction in tracheotomies in the NPPV group compared with the IMV group, but the results were only significant in 1 study (13% vs. 23.1%, P = 0.29; and 6.4% vs. 34.6%; P < 0.001).
GRADE: very low
Other Outcomes
One of the studies followed patients for 12 months. At the end of follow-up, patients in the NPPV group had a significantly lower rate of needing de novo oxygen supplementation at home. In addition, the IMV group experienced significant increases in functional limitations due to COPD, while no increase was seen in the NPPV group. Finally, no significant differences were observed for hospital readmissions, ICU readmissions, and patients with an open tracheotomy, between the NPPV and IMV groups.
NPPV for Weaning COPD Patients From IMV
A total of 80 participants were included in the 2 RCTs; the sample sizes of the studies were 30 and 50 patients. The mean age of the participants ranged from 58 to 69 years of age. Based on either the GOLD COPD stage criteria or the mean percent predicted FEV1, both studies included patients with very severe COPD. Both studies also included patients with very severe respiratory failure (mean pH of the study populations was less than 7.23). Chronic obstructive pulmonary disease patients receiving IMV were enrolled in the study if they failed a T-piece weaning trial (spontaneous breathing test), so they could not be directly extubated from IMV.
Both studies were conducted in the ICU. Patients in the NPPV group received weaning using either BiPAP or pressure support ventilation NPPV through a face mask, and patients in the IMV weaning group received pressure support ventilation. In both cases, weaning was achieved by tapering the ventilation level.
The individual quality of the studies ranged. Common methodological problems included unclear randomization methods and allocation concealment, lack of blinding, and small sample size.
Mortality
Both studies reported mortality as an outcome. The pooled results showed a significant reduction in ICU mortality in the NPPV group compared with the IMV group (RR, 0.47; 95% CI, 0.23−0.97; P = 0.04).
GRADE: moderate
Intensive Care Unit Length of Stay
Both studies reported ICU LOS as an outcome. The pooled results showed a nonsignificant reduction in ICU LOS in the NPPV group compared with the IMV group (WMD, −5.21 days; 95% CI, −11.60 to 1.18 days).
GRADE: low
Duration of Mechanical Ventilation
Both studies reported duration of mechanical ventilation (including both invasive and noninvasive ventilation) as an outcome. The pooled results showed a nonsignificant reduction in duration of mechanical ventilation (WMD, −3.55 days; 95% CI, −8.55 to 1.44 days).
GRADE: low
Nosocomial Pneumonia
Both studies reported nosocominal pneumonia as an outcome. The pooled results showed a significant reduction in nosocomial pneumonia in the NPPV group compared with the IMV group (RR, 0.14; 95% CI, 0.03−0.71; P = 0.02).
GRADE: moderate
Weaning Failure
One study reported a significant reduction in weaning failure in the NPPV group compared with the IMV group, but the results were not reported in the publication. In this study, 1 of 25 patients in the NPPV group and 2 of 25 patients in the IMV group could not be weaned after 60 days in the ICU.
NPPV After Extubation of COPD Patients From IMV
The literature was reviewed to identify studies examining the effectiveness of NPPV compared with UMC in preventing recurrence of ARF after extubation from IMV or treating acute ARF which has recurred after extubation from IMV. No studies that included only COPD patients or reported results for COPD patients separately were identified for the prevention of ARF postextubation.
One study was identified for the treatment of ARF in COPD patients that recurred within 48 hours of extubation from IMV. This study included 221 patients, of whom 23 had COPD. A post hoc subgroup analysis was conducted examining the rate of reintubation in the COPD patients only. A nonsignificant reduction in the rate of reintubation was observed in the NPPV group compared with the UMC group (7 of 14 patients vs. 6 of 9 patients, P = 0.67). GRADE: low
Conclusions
NPPV Plus UMC Versus UMC Alone for First Line Treatment of ARF due to Acute Exacerbations of COPD
Moderate quality of evidence showed that compared with UMC, NPPV plus UMC significantly reduced the need for endotracheal intubation, inhospital mortality, and the mean length of hospital stay.
Low quality of evidence showed a lower rate of complications in the NPPV plus UMC group compared with the UMC group.
NPPV Versus IMV for the Treatment of ARF in Patients Who Have Failed UMC
Due to inconsistent and low to very low quality of evidence, there was insufficient evidence to draw conclusions on the comparison of NPPV versus IMV for patients who failed UMC.
NPPV for Weaning COPD Patients From IMV
Moderate quality of evidence showed that weaning COPD patients from IMV using NPPV results in significant reductions in mortality, nosocomial pneumonia, and weaning failure compared with weaning with IMV.
Low quality of evidence showed a nonsignificant reduction in the mean LOS and mean duration of mechanical ventilation in the NPPV group compared with the IMV group.
NPPV for the Treatment of ARF in COPD Patients After Extubation From IMV
Low quality of evidence showed a nonsignificant reduction in the rate of reintubation in the NPPV group compared with the UMC group; however, there was inadequate evidence to draw conclusions on the effectiveness of NPPV for the treatment of ARF in COPD patients after extubation from IMV
PMCID: PMC3384377  PMID: 23074436
2.  Circulating Mitochondrial DNA in Patients in the ICU as a Marker of Mortality: Derivation and Validation 
PLoS Medicine  2013;10(12):e1001577.
In this paper, Choi and colleagues analyzed levels of mitochondrial DNA in two prospective observational cohort studies and found that increased mtDNA levels are associated with ICU mortality, and improve risk prediction in medical ICU patients. The data suggests that mtDNA could serve as a viable plasma biomarker in MICU patients.
Background
Mitochondrial DNA (mtDNA) is a critical activator of inflammation and the innate immune system. However, mtDNA level has not been tested for its role as a biomarker in the intensive care unit (ICU). We hypothesized that circulating cell-free mtDNA levels would be associated with mortality and improve risk prediction in ICU patients.
Methods and Findings
Analyses of mtDNA levels were performed on blood samples obtained from two prospective observational cohort studies of ICU patients (the Brigham and Women's Hospital Registry of Critical Illness [BWH RoCI, n = 200] and Molecular Epidemiology of Acute Respiratory Distress Syndrome [ME ARDS, n = 243]). mtDNA levels in plasma were assessed by measuring the copy number of the NADH dehydrogenase 1 gene using quantitative real-time PCR. Medical ICU patients with an elevated mtDNA level (≥3,200 copies/µl plasma) had increased odds of dying within 28 d of ICU admission in both the BWH RoCI (odds ratio [OR] 7.5, 95% CI 3.6–15.8, p = 1×10−7) and ME ARDS (OR 8.4, 95% CI 2.9–24.2, p = 9×10−5) cohorts, while no evidence for association was noted in non-medical ICU patients. The addition of an elevated mtDNA level improved the net reclassification index (NRI) of 28-d mortality among medical ICU patients when added to clinical models in both the BWH RoCI (NRI 79%, standard error 14%, p<1×10−4) and ME ARDS (NRI 55%, standard error 20%, p = 0.007) cohorts. In the BWH RoCI cohort, those with an elevated mtDNA level had an increased risk of death, even in analyses limited to patients with sepsis or acute respiratory distress syndrome. Study limitations include the lack of data elucidating the concise pathological roles of mtDNA in the patients, and the limited numbers of measurements for some of biomarkers.
Conclusions
Increased mtDNA levels are associated with ICU mortality, and inclusion of mtDNA level improves risk prediction in medical ICU patients. Our data suggest that mtDNA could serve as a viable plasma biomarker in medical ICU patients.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Intensive care units (ICUs, also known as critical care units) are specialist hospital wards that provide care for people with life-threatening injuries and illnesses. In the US alone, more than 5 million people are admitted to ICUs every year. Different types of ICUs treat different types of problems. Medical ICUs treat patients who, for example, have been poisoned or who have a serious infection such as sepsis (blood poisoning) or severe pneumonia (inflammation of the lungs); trauma ICUs treat patients who have sustained a major injury; cardiac ICUs treat patients who have heart problems; and surgical ICUs treat complications arising from operations. Patients admitted to ICUs require constant medical attention and support from a team of specially trained nurses and physicians to prevent organ injury and to keep their bodies functioning. Monitors, intravenous tubes (to supply essential fluids, nutrients, and drugs), breathing machines, catheters (to drain urine), and other equipment also help to keep ICU patients alive.
Why Was This Study Done?
Although many patients admitted to ICUs recover, others do not. ICU specialists use scoring systems (algorithms) based on clinical signs and physiological measurements to predict their patients' likely outcomes. For example, the APACHE II scoring system uses information on heart and breathing rates, temperature, levels of salts in the blood, and other signs and physiological measurements collected during the first 24 hours in the ICU to predict the patient's risk of death. Existing scoring systems are not perfect, however, and “biomarkers” (molecules in bodily fluids that provide information about a disease state) are needed to improve risk prediction for ICU patients. Here, the researchers investigate whether levels of circulating cell-free mitochondrial DNA (mtDNA) are associated with ICU deaths and whether these levels can be used as a biomarker to improve risk prediction in ICU patients. Mitochondria are cellular structures that produce energy. Levels of mtDNA in the plasma (the liquid part of blood) increase in response to trauma and infection. Moreover, mtDNA activates molecular processes that lead to inflammation and organ injury.
What Did the Researchers Do and Find?
The researchers measured mtDNA levels in the plasma of patients enrolled in two prospective observational cohort studies that monitored the outcomes of ICU patients. In the Brigham and Women's Hospital Registry of Critical Illness study, blood was taken from 200 patients within 24 hours of admission into the hospital's medical ICU. In the Molecular Epidemiology of Acute Respiratory Distress Syndrome study (acute respiratory distress syndrome is a life-threatening inflammatory reaction to lung damage or infection), blood was taken from 243 patients within 48 hours of admission into medical and non-medical ICUs at two other US hospitals. Patients admitted to medical ICUs with a raised mtDNA level (3,200 or more copies of a specific mitochondrial gene per microliter of plasma) had a 7- to 8-fold increased risk of dying within 28 days of admission compared to patients with mtDNA levels of less than 3,200 copies/µl plasma. There was no evidence of an association between raised mtDNA levels and death among patients admitted to non-medical ICUs. The addition of an elevated mtDNA level to a clinical model for risk prediction that included the APACHE II score and biomarkers that are already used to predict ICU outcomes improved the net reclassification index (an indicator of the improvement in risk prediction algorithms offered by new biomarkers) of 28-day mortality among medical ICU patients in both studies.
What Do These Findings Mean?
These findings indicate that raised mtDNA plasma levels are associated with death in medical ICUs and show that, among patients in medical ICUs, measurement of mtDNA plasma levels can improve the prediction of the risk of death from the APACHE II scoring system, even when commonly measured biomarkers are taken into account. These findings do not indicate whether circulating cell-free mtDNA increased because of the underlying severity of illness or whether mtDNA actively contributes to the disease process in medical ICU patients. Moreover, they do not provide any evidence that raised mtDNA levels are associated with an increased risk of death among non-medical (mainly surgical) ICU patients. These findings need to be confirmed in additional patients, but given the relative ease and rapidity of mtDNA measurement, the determination of circulating cell-free mtDNA levels could be a valuable addition to the assessment of patients admitted to medical ICUs.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001577.
The UK National Health Service Choices website provides information about intensive care
The Society of Critical Care Medicine provides information for professionals, families, and patients about all aspects of intensive care
MedlinePlus provides links to other resources about intensive care (in English and Spanish)
The UK charity ICUsteps supports patients and their families through recovery from critical illness; its booklet Intensive Care: A Guide for Patients and Families is available in English and ten other languages; its website includes patient experiences and relative experiences of treatment in ICUs
Wikipedia has a page on ICU scoring systems (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
doi:10.1371/journal.pmed.1001577
PMCID: PMC3876981  PMID: 24391478
3.  Patients' recollections of experiences in the intensive care unit may affect their quality of life 
Critical Care  2005;9(2):R96-R109.
Introduction
We wished to obtain the experiences felt by patients during their ICU stay using an original questionnaire and to correlate the memories of those experiences with health-related quality of life (HR-QOL).
Methods
We conducted a prospective study in 10 Portuguese intensive care units (ICUs). Six months after ICU discharge, an original questionnaire on experiences of patients during their ICU stay, the recollection questionnaire, was delivered. HR-QOL was evaluated simultaneously, with the EQ-5D questionnaire. Between 1 September 2002 and 31 March 2003 1433 adult patients were admitted. ICU and hospital mortalities were 21% and 28%, respectively. Six months after ICU discharge, 464 patients completed the recollection questionnaire.
Results
Thirty-eight percent of the patients stated they did not remember any moment of their ICU stay. The ICU environment was described as friendly and calm by 93% of the patients. Sleep was described as being good and enough by 73%. The experiences reported as being more stressful were tracheal tube aspiration (81%), nose tube (75%), family worries (71%) and pain (64%). Of respondents, 51% experienced dreams and nightmares during their ICU stay; of these, 14% stated that those dreams and nightmares disturb their present daily life and they exhibit a worse HR-QOL. Forty-one percent of patients reported current sleep disturbances, 38% difficulties in concentrating in current daily activities and 36% difficulties in remembering recent events. More than half of the patients reported more fatigue than before the ICU stay. Multiple and linear regression analysis showed that older age, longer ICU stay, higher Simplified Acute Physiology Score II, non-scheduled surgery and multiple trauma diagnostic categories, present sleep disturbances, daily disturbances by dreams and nightmares, difficulties in concentrating and difficulties in remembering recent events were independent predictors of worse HR-QOL. Multicollinearity analysis showed that, with the exception of the correlation between admission diagnostic categories and length of ICU stay (0.47), all other correlations between the independent variables and coefficient estimates included in the regression models were weak (below 0.30).
Conclusion
This study suggests that neuropsychological consequences of critical illness, in particular the recollection of ICU experiences, may influence subsequent HR-QOL.
doi:10.1186/cc3026
PMCID: PMC1175917  PMID: 15774056
critical illness; follow-up; health-related quality of life; intensive care; neuropsychological sequelae; outcome
4.  Quality of dying in the ICU: Is it worse for patients admitted from the hospital ward compared to those admitted from the emergency department? 
Intensive care medicine  2014;40(11):1688-1697.
Objective
Although most intensive care unit (ICU) admissions originate in the emergency department (ED), a substantial number of admissions arrive from hospital wards. Patients transferred from the hospital ward often share clinical characteristics with patients admitted from the ED, but family expectations may differ. An understanding of the impact of ICU admission source on family perceptions of end-of-life care may help improve patient and family outcomes by identifying those at risk for poor outcomes.
Design and Setting
Cohort study of patients with chronic illness and acute respiratory failure requiring mechanical ventilation who died after ICU admission in 14 Seattle-Tacoma area hospitals between 2003 and 2008 (n=1500).
Measurements
Using regression models adjusted for hospital site and patient-, nurse- and family-level characteristics, we examined associations between ICU admission source (hospital ward versus ED) and 1) family ratings of satisfaction with ICU care, 2) family and nurse ratings of quality of dying; and 3) chart-based indicators of palliative care.
Main Results
Admission from the hospital ward was associated with lower family ratings of quality of dying (β −0.90, 95% confidence interval (CI) −1.54,−0.26, p=0.006) and satisfaction (total score β −3.97, 95% CI −7.89,−0.05, p=0.047; satisfaction with care domain score β −5.40, 95% CI −9.44,−1.36, p=0.009). Nurses did not report differences in quality of dying. Patients from hospital wards were less likely to have family conferences (odds ratio (OR) 0.68, 95% CI 0.52,0.88, p=0.004) or discussion of prognosis in the first 72 hours after ICU admission (OR 0.72, 95% CI 0.56,0.91, p=0.007) but were more likely to receive spiritual care (OR 1.48, 95% CI 1.14,1.93, p=0.003) or have life support withdrawn (OR 1.38, 95% CI 1.04,1.82, p=0.025).
Conclusion
Admission from the hospital ward is associated with family perceptions of lower quality of dying and less satisfaction with ICU care. Differences in receipt of palliative care suggest that family of patients from the hospital ward receive less communication. Nurse ratings of quality of dying did not significantly differ by ICU admission source, suggesting dissimilarities between family and nurse perspectives. This study identifies a patient population at risk for poor quality palliative and end-of-life care. Future studies are needed to identify interventions to improve care for patients who deteriorate on the wards following hospital admission.
doi:10.1007/s00134-014-3425-2
PMCID: PMC4350659  PMID: 25116294
End-of life care; intensive; care; critical care; palliative care; quality
5.  Variability of ICU Use in Adult Patients With Minor Traumatic Intracranial Hemorrhage 
Annals of emergency medicine  2012;61(5):10.1016/j.annemergmed.2012.08.024.
Study objective
Patients with minor traumatic intracranial hemorrhage are frequently admitted to the ICU, although many never require critical care interventions. To describe ICU resource use in minor traumatic intracranial hemorrhage, we assess (1) the variability of ICU use in a cohort of patients with minor traumatic intracranial hemorrhage across multiple trauma centers, and (2) the proportion of adult patients with traumatic intracranial hemorrhage who are admitted to the ICU and never receive a critical care intervention during hospitalization. In addition, we evaluate the association between ICU admission and key independent variables.
Methods
A structured, historical cohort study of adult patients (aged 18 years and older) with minor traumatic intracranial hemorrhage was conducted within a consortium of 8 Level I trauma centers in the western United States from January 2005 to June 2010. The study population included patients with minor traumatic intracranial hemorrhage, defined as an emergency department (ED) Glasgow Coma Scale (GCS) score of 15 (normal mental status) and an Injury Severity Score less than 16 (no other major organ injury). The primary outcome measure was initial ICU admission. The secondary outcome measure was a critical care intervention during hospitalization. Critical care interventions included mechanical ventilation, neurosurgical intervention, transfusion of blood products, vasopressor or inotrope administration, and invasive hemodynamic monitoring. ED disposition and the proportion of ICU patients not receiving a critical care intervention were compared across sites with descriptive statistics. The association between ICU admission and predetermined independent variables was analyzed with multivariable regression.
Results
Among 11,240 adult patients with traumatic intracranial hemorrhage, 1,412 (13%) had minor traumatic intracranial hemorrhage and complete ED disposition data (mean age 48 years; SD 20 years). ICU use within this cohort across sites ranged from 50% to 97%. Overall, 847 of 888 patients (95%) with minor traumatic intracranial hemorrhage who were admitted to the ICU did not receive a critical care intervention during hospitalization (range between sites 80% to 100%). Three of 524 (0.6%) patients discharged home or admitted to the observation unit or ward received a critical care intervention. After controlling for severity of injury (age, blood pressure, and Injury Severity Score), study site was independently associated with ICU admission (odds ratios ranged from 1.5 to 30; overall effect P<.001).
Conclusion
Across a consortium of trauma centers in the western United States, there was wide variability in ICU use within a cohort of patients with minor traumatic intracranial hemorrhage. Moreover, a large proportion of patients admitted to the ICU never required a critical care intervention, indicating the potential to improve use of critical care resources in patients with minor traumatic intracranial hemorrhage.
doi:10.1016/j.annemergmed.2012.08.024
PMCID: PMC3880139  PMID: 23021347
6.  Discomfort and factual recollection in intensive care unit patients 
Critical Care  2004;8(6):R467-R473.
Introduction
A stay in the intensive care unit (ICU), although potentially life-saving, may cause considerable discomfort to patients. However, retrospective assessment of discomfort is difficult because recollection of stressful events may be impaired by sedation and severe illness during the ICU stay. This study addresses the following questions. What is the incidence of discomfort reported by patients recently discharged from an ICU? What were the sources of discomfort reported? What was the degree of factual recollection during patients' stay in the ICU? Finally, was discomfort reported more often in patients with good factual recollection?
Methods
All ICU patients older than 18 years who had needed prolonged (>24 hour) admission with tracheal intubation and mechanical ventilation were consecutively included. Within three days after discharge from the ICU, a structured, in-person interview was conducted with each individual patient. All patients were asked to complete a questionnaire consisting of 14 questions specifically concerning the environment of the ICU they had stayed in. Furthermore, they were asked whether they remembered any discomfort during their stay; if they did then they were asked to specify which sources of discomfort they could recall. A reference group of surgical ward patients, matched by sex and age to the ICU group, was studied to validate the questionnaire.
Results
A total of 125 patients discharged from the ICU were included in this study. Data for 123 ICU patients and 48 surgical ward patients were analyzed. The prevalence of recollection of any type of discomfort in the ICU patients was 54% (n = 66). These 66 patients were asked to identify the sources of discomfort, and presence of an endotracheal tube, hallucinations and medical activities were identified as such sources. The median (min–max) score for factual recollection in the ICU patients was 15 (0–28). The median (min–max) score for factual recollection in the reference group was 25 (19–28). Analysis revealed that discomfort was positively related to factual recollection (odds ratio 1.1; P < 0.001), especially discomfort caused by the presence of an endotracheal tube, medical activities and noise. Hallucinations were reported more often with increasing age. Pain as a source of discomfort was predominantly reported by younger patients.
Conclusion
Among postdischarge ICU patients, 54% recalled discomfort. However, memory was often impaired: the median factual recollection score of ICU patients was significantly lower than that of matched control patients. The presence of an endotracheal tube, hallucinations and medical activities were most frequently reported as sources of discomfort. Patients with a higher factual recollection score were at greater risk for remembering the stressful presence of an endotracheal tube, medical activities and noise. Younger patients were more likely to report pain as a source of discomfort.
doi:10.1186/cc2976
PMCID: PMC1065072  PMID: 15566593
discomfort; hallucinations; intensive care unit; recollection
7.  Advanced accident research system based on a medical and engineering data in the metropolitan area of Florence 
Background
In the metropolitan area of Florence, 62% of major traumas involve powered two wheeler rider and pillion passengers, 10% cyclists, and 7% pedestrians. The urban and extra-urban areas are the most dangerous for the vulnerable road user. In-depth investigations are needed for assessing detailed information on road accidents. This type of study has been very limited in time frame in Italy, and completely absent in the Tuscan region.
Consequently a study called “In-depth Study of road Accident in FlorencE” (In-SAFE) has been initiated.
Methods
A network between the Department of Mechanics and Industrial Technologies (University of Florence) and the Intensive Care Unit of the Emergency Department (Careggi Teaching Hospital, Florence) was created with the aim of collecting information about the road accidents. The data collected includes: on-scene data, data coming from examination of the vehicles, kinematics and dynamic crash data, injuries, treatment, and injury mechanisms. Each injury is codified thorough the AIS score, localized by a three-dimensional human body model based on computer tomography slices, and the main scores are calculated. We then associate each injury with its cause and crash technical parameters. Finally, all the information is collected in the In-SAFE database.
Results
Patient mean age at the time of the accident was 34.6 years, and 80% were males. The ISS mean is 24.2 (SD 8.7) and the NISS mean is 33.6 (SD 10.5). The main road accident configurations are the “car-to-PTW” (25%) and “pedestrian run over” (17,9%). For the former, the main collision configuration is “head-on crash” (57%). Cyclists and PTW riders-and-pillions-passengers suffer serious injuries (AIS3+) mainly to the head and the thorax. The head (56.4%) and the lower extremities (12.7%) are the most frequently injured pedestrian body regions.
Conclusions
The aim of the project is to create an in-depth road accident study with special focus on the correlation between technical parameters and injuries. An in-depth investigation team was setup and is currently active in the metropolitan area of Florence.
Twenty-eight serious road accidents involving twenty-nine ICU patients are studied. PTW users, cyclist and pedestrians are the most frequently involved in metropolitan accidents.
doi:10.1186/1471-227X-13-3
PMCID: PMC3606293  PMID: 23496830
In-depth accident database; Injury mechanism; Injury pattern; Biomechanics; Road accident; Injury causes
8.  Short-term outcome and differences between rural and urban trauma patients treated by mobile intensive care units in Northern Finland: a retrospective analysis 
Background
Emergency medical services are an important part of trauma care, but data comparing urban and rural areas is needed. We compared 30-day mortality and length of intensive care unit (ICU) stay for trauma patients injured in rural and urban municipalities and collected basic data on trauma care in Northern Finland.
Methods
We examined data from all trauma patients treated by the Finnish Helicopter Emergency Medical Services in 2012 and 2013. Only patients surviving to hospital were included in the analysis but all pre-hospital deaths were recorded. All data was retrieved from the national Helicopter Emergency Medical Services database, medical records, and the Finnish Causes of Death Registry. Patients were defined as urban or rural depending on the type of municipality where the injury occurred.
Results
A total of 472 patients were included. Age and Injury Severity Score did not differ between rural and urban patients. The pre-hospital time intervals and distances to trauma centers were longer for rural patients and a larger proportion of urban patients had intentional injuries (23.5 % vs. 9.3 %, P <0.001). The 30-day mortality for severely injured patients (Injury Severity Score >15) was 23.9 % in urban and 13.3 % in rural municipalities. In the multivariate regression analysis the odds ratio (OR) for 30-day mortality was 2.8 (95 % confidence interval 1.0 to 7.9, P = 0.05) in urban municipalities. There was no difference in the length of ICU stay or scores. Twenty patients died on scene or during transportation and 56 missions were aborted because of pre-hospital death.
Conclusions
The severely injured urban trauma patients had a trend toward higher 30-day mortality compared with patients injured in rural areas but the length of ICU stay was similar. However, more pre-hospital deaths occurred in rural municipalities. The time before mobile ICU arrival appears to be critical for trauma patients’ survival, especially in rural areas.
doi:10.1186/s13049-015-0175-2
PMCID: PMC4635532  PMID: 26542684
Emergency medical services; Helicopter; Rural; Urban; Finland
9.  Prospective cohort study protocol to describe the transfer of patients from intensive care units to hospital wards 
BMJ Open  2015;5(7):e007913.
Introduction
The transfer of patient care between the intensive care unit (ICU) and the hospital ward is associated with increased risk of medical error and adverse events. This study will describe patient transfer from ICU to hospital ward by documenting (1) patient, family and provider experiences related to ICU transfer, (2) communication between stakeholders involved in ICU transfer, (3) adverse events that follow ICU transfer and (4) opportunities to improve ICU to hospital ward transfer.
Methods
This is a mixed methods prospective observational study of ICU to hospital ward transfer practices in 10 ICUs across Canada. We will recruit 50 patients at each site (n=500) who are transferred from ICU to hospital ward, and distribute surveys to enrolled patients, family members, and healthcare providers (ICU and ward physicians and nurses) after patient transfer. A random sample of 6 consenting study participants (patients, family members, healthcare providers) from each study site (n=60) will be offered an opportunity to participate in interviews to further describe stakeholders’ experience with ICU to hospital ward transfer. We will abstract information from patient health records to identify clinical data and use of transfer tools, and identify adverse events that are related to the transfer.
Ethics and Dissemination
Research ethics board approval has been obtained at the coordinating study centre (UofC REB13-0021) and 5 study sites (UofA Pro00050646; UBC-PHC H14-01667; Sunnybrook 336-2014; QCH 14-07; Sherbrooke 14-172). Dissemination of the findings will provide a comprehensive description of transfer from ICU to hospital ward in Canada including the uptake of validated or local transfer tools, a conceptual framework of the experiences and needs of stakeholders in the ICU transfer process, a summary of adverse events experienced by patients after transfer from ICU to hospital ward, and opportunities to guide quality improvement efforts.
doi:10.1136/bmjopen-2015-007913
PMCID: PMC4499701  PMID: 26155820
10.  Electrical injuries. Biological values measurements as a prediction factor of local evolution in electrocutions lesions 
Journal of Medicine and Life  2014;7(2):226-236.
Abstract
Rationale. Taking into account the incidence and the severity of electrocutions, we consider it extremely necessary to find effective, appropriate and particularized therapeutic solutions aimed at improving the survival, decreasing the mortality, ensuring a superior functional and aesthetic effect and facilitating the social reintegration.
Given the severity of the general condition of the electrically injured patient and the fact that any worsening of the lesions has a systemic echo, the selection of the timing for re-excision is very important.
The postponement of the surgical timing can break the precarious metabolic equilibrium and can hasten the installation of the multisystem organ failure (MSOF).
Objective. The study is intended to establish a possible connection between the clinical evolution of the electrically injured patient and the dynamics of three important biological parameters, able to provide data concerning the therapeutic attitude to be followed.
The patients with a diagnostic of high-voltage electrocution, who will be admitted to the Clinic, will be followed for a period of 2 years. The parameters to be followed daily will be:
- Creatin-kinase, as a marker of muscular damage
- Hemoglobin, as a marker of tissue oxygenation
- Leukocytes, as an indicator of a possible septic evolution.
The therapeutic alternatives, including the administration of antiplatelet drugs will be studied.
Methods and Results. In the period October 2010-June 2013 a total of 12 cases of high-voltage electrocution were admitted in our clinic. Among these, some could be placed in the study of 7 cases, as the remaining patients died within the first 24 hours of hospitalization due to the endured lesions.
All the patients were admitted to the ICU ward that supported the treatment and monitoring until their stabilization, at which time they were transferred to the ward.
All the patients received anti-thromboxane treatment from their admission (injectable NSAIDs associated with antisecretory drugs). By mutual agreement with ICU service, Dipyridamole was not introduced because of the “steal effect” in the viable areas to the detriment of the already ischemic areas, the drug effect being obvious in vitro, but hard to be proven in the clinical case.
The relationship between the CK level and the clinical appearance of the ischemic areas is relative. We cannot conclude that an increased level of CK is equivalent to an enlarged ischemic area and even less it does not provide us direct information concerning the best time for re-excision.
The presence of a viable blood supply around the necrotic tissue will lead to an important resorption of degradation products in that area, a quasinormal level of CK having no value. The sealing of the necrosis areas and the lack of immediate resorption does not have a positive prognostic value. Taking into account that the electrocutions are mostly multiple injuries, the CK level can increase even after some muscular damages, fractures, independent of the actual electrocution lesion.
In one case, the patient suffered from electrocution at both thoracic limbs. With the carbonization of the hands and grifa installed up to the level of the elbow fold, he stayed for 6 hours at the accident site until he had been recovered. At the moment of presentation to the hospital, his consciousness condition was satisfactory but the CK level was of over 20000 IU, becoming rapidly non-detectable, in combination with black urine. The patient's condition deteriorated quickly, and, although the bilateral shoulder disarticulation has been carried out, he died in the next 12 hours.
Discussion. As a conclusion, the CK level did not prove itself a prognostic for the surgical timing or the actual surgical attitude and could be influenced by a whole series of factors, dependent or not on the electrocution lesion.
A radical attitude is to be preferred in cases with established ischemia; the prognostic being the more reserved the larger the damage and the longer the period of time from the event. The established treatment is of renal support and treatment of acute renal injury (AKI) subsequently installed.
An increased level of leukocytes is always present as in any severe trauma, even if there are no immediate signs of infection of the electrocution lesions.
Taking into account that the electrocution lesion as well as the one caused by burning destroys the natural defense barrier represented by the skin, the infection risk is major and that is why the therapeutic protocol stipulates the immediate establishment of a treatment with broad-spectrum antibiotics or with an association of antibiotics.
The increase of the leukocytes level under antibiotics treatment involves either the contamination with a germ that is not sensitive to the respective antibiotic or the persistence of necrosis areas which secondarily infect, and where antibiotic penetration is very low. Therefore, the excision of the compromised tissues is an absolute necessity.
In terms of prognostic, the increase of the leukocytes number signified an insufficient excision and indicated the resuming and deepening of the excisions. Taking into account that the patient has been admitted through the ICU service, the risk of contracting severe infections with selected germs is real. Another risk is that of infection with Clostridium difficile following the prolonged utilization of broad-spectrum antibiotics, especially in patients with associated diseases and reduced immunity per primam.
The existence of completely separate circuits should solve the problem of contamination with bacteria of selected species; unfortunately, in our cases, we have faced this problem and the utilization of last choice antibiotics (Imipenem, Vancomycin, Targocid, etc.) as well as the association of immunoglobulins was necessary.
All the patients admitted in the study received anti-thromboxane drugs in order to limit the ischemic process at tissue level. Despite the efforts we have made, the lack of blood and its derivatives or simply the negligence in patient monitoring, allowed the decrease, even transient of the Hb level, sometimes only for a few hours, but enough to allow the deepening of the ischemic lesions.
Excisions were carried out in all the patients in emergency or even amputations of the extremities, with the wish to limit the extension of the ischemic lesions and the resorption of cell degradation products.
The amputations performed in emergency did not always represent a saving solution; however, they remained the most effective measures when they were carried out immediately after the accident and obviously in viable tissue.
The increase of CK is not an indicative factor itself in making re-excisions but orients the therapeutic approach, the utilization of the dialysis when the values do not decrease by treatment for renal support and the forcing of diuresis is required.
The normalization of CK indicates the time when we can start the covering of the defects resulted as a consequence of the excisions.
The level of the leukocytes represents both a prognostic factor and an indicative factor for the re-excision of the ischemic areas. An increased level under antibiotic therapy signifies either an incomplete excision or the contamination with flora resisting to the antibiotic that has been used.
In the light of findings in the caring of the patients with electrocutions, I propose several caring/assessment protocols for the severe electrically injured patient.
PMCID: PMC4197509  PMID: 25408731
electrical injuries; electrocutions; electrically-injured patient; CK level; carbonization
11.  Fluid resuscitation protocols for burn patients at intensive care units of the United Kingdom and Ireland 
Introduction: The objective of this study was to determine the thermal injury fluid resuscitation protocols at intensive care units (ICUs) in the United Kingdom and Ireland.
Materials and methods: A telephone questionnaire was designed to survey the fluid resuscitation protocols of ICUs at all hospitals with plastic/burn surgery departments in the British Isles in 2010. The feedback from the questionnaire was from the senior nurse in charge of the ICUs.
Results: 32/64 (50%) of these ICUs had provided care to burns patients. A 100% response from these 32 units was obtained. 71.4% commence fluid resuscitation at 15% total body surface area burn (TBSA), 21.4% at 20% TBSA and 7.1% at 10% TBSA in adults. The estimated resuscitation volume was most often calculated using the Parkland/Modified Parkland formula (87.5%) or the Muir and Barclay formula (12.5%). Interestingly, of the ICUs using formulae, two had recently moved from using the Muir and Barclay formula to Parkland formula and one had recently moved from using the Parkland formula to Muir and Barclay formula. Despite this, 37.5% of ICUs using a formula did not rigidly follow it exactly. The most commonly used resuscitation fluid was Ringer’s lactate solution (46.9%) and Human Albumin Solution was used in 12.5%. No ICU used red cell concentrate as a first line fluid. 18.8% used a central line. 40.6% ICUs considered changing the IV solution during resuscitation. 78.1% ICUs consider urine output to be the most important factor in modifying resuscitation volumes. 59.4% ICUs calculate a maintenance fluid rate after completion of resuscitation. The endpoint for resuscitation was at 24 h in 46.9% ICUs and at 36 h in 9.4%. 5/32 (16%) felt their protocol gave too little and 6/32 (19%) felt their protocol gave too much. 59.3% ICUs gave oral/enteral fluids by naso-gastric or naso-jejenal tubes. 21.9% felt that oral/enteral resuscitation worked. Exactly half of the units believed that the formula that they used provided approximately the right amount of fluid, with 25% believing that it provided too much and 21.9% that it provided too little.
Discussion and conclusion: There is substantial variation in the fluid resuscitation protocols for burns of ICUs in the British Isles. The different practices demonstrated in this survey may have important consequences as inadequate fluid resuscitation can limit perfusion to potentially recoverable burns, grafted tissue and body organs not directly injured.
doi:10.3205/000137
PMCID: PMC3118694  PMID: 21698088
burns; fluid resuscitation; colloids; crystalloids
12.  Medical Emergency Team: How do we play when we stay? Characterization of MET actions at the scene 
Background
The creation, implementation and effectiveness of a medical emergency team (MET) in every hospital is encourage and supported by international bodies of quality certification. Issues such as what is the best composition of the team or the interventions performed by the MET at the scene and the immediate outcomes of the patients after MET intervention have not yet been sufficiently explored. The purpose of the study is to characterize MET actions at the scene and the immediate patient outcome.
Methods
Retrospective cohort study, at a tertiary care, university-affiliated, 600-bed hospital, in the north of Portugal, over two years.
Results
There were 511 MET activations: 389 (76 %) were for inpatients. MET activation rate was 8.6/1,000 inpatients. The main criteria for activation were airway threatening in 143 (36.8 %), concern of medical staff in 121 (31.1 %) and decrease in GCS > 2 in 98 (25.2 %) patients; MET calls for cardiac arrest occurred in 68 patients (17.5 %). The median (IQR) time the team stayed at the scene was 35 (20–50) minutes. At the scene, the most frequent actions were related to airway and ventilation, namely oxygen administration in 145 (37.3 %); in circulation, fluid were administered in 158 (40.6 %); overall medication was administered in 185 (47.5 %) patients. End-of-life decisions were part of the MET actions in 94 (24.1 %) patients. At the end of MET intervention, 73 (18.7 %) patients died at the scene, 190 (60.7 %) stayed on the ward and the remaining 123 patients were transferred to an increased level of care. Crude hospital mortality rate was 4.1 % in the 3 years previously to MET implementation and 3.6 % in the following 3 years (p < 0.001).
Discussion
During the study period, the rate of activation for medical inpatients was significantly higher than that for surgical inpatients. In our hospital, there is no 24/7 medical cover on the wards, with the exception of high-dependency and intensive care units; assuming that the number of unplanned admissions and chronic ill patients is greater in medical wards that could explain the difference found, which prompts the implementation of a 24/7 ward residence.
The team stayed on site for half an hour and during that time most of the actions were simple and nurse-driven, but in one third of all activations medical actions were taken, and in a forth (24%) end-of-life decisions made, reinforcing the inclusion of a doctor in the MET. A significant decrease in overall hospital mortality rate was observed after the implementation of the MET.
Conclusions
The composition of our MET with an ICU doctor and nurse was reinforced by the need of medical actions in more than half of the situations (either clinical actions or end-of-life decisions). After MET implementation there was a significant decrease in hospital mortality. This study reinforces the benefit of implementing an ICU-MET team.
doi:10.1186/s13049-016-0222-7
PMCID: PMC4802603  PMID: 27000277
Medical Emergency Team; Rapid Response Team; Cardiac Arrest Team; Efferent limb; Activation criteria; Actions at the scene; Immediate outcome
13.  Relationship between ICU bed availability, ICU readmission, and cardiac arrest on the general wards 
Critical care medicine  2014;42(9):2037-2041.
Objective
The decision to admit a patient to the intensive care unit (ICU) is complex, reflecting patient factors and available resources. Previous work has shown that ICU census does not impact mortality of patients admitted to the ICU. However, the effect of ICU bed availability on patients outside the ICU is unknown. We sought to determine the association between ICU bed availability, ICU readmissions, and ward cardiac arrests.
Design
In this observational study using data collected between 2009 and 2011, rates of ICU readmission and ward cardiac arrest were determined per 12-hour shift. The relationship between these rates and the number of available ICU beds at the start of each shift (accounting for census and nursing capacity), were investigated. Grouped logistic regression was used to adjust for potential confounders.
Setting
Five specialized adult ICUs comprising 63 adult ICU beds in an academic medical center.
Patients
Any patient admitted to a non-ICU inpatient unit was counted in the ward census and considered at risk for ward cardiac arrest. Patients discharged from an ICU were considered at risk for ICU readmission.
Measurements and Main Results
Data were available for 2086 of 2190 shifts. The odds of ICU readmission increased with each decrease in the overall number of available ICU beds (OR=1.06 [95% CI, 1.00–1.12], p=0.03), with a similar but not statistically significant association demonstrated in ward cardiac arrest rate (OR= 1.06 [95% CI, 0.98–1.14], p=0.16). In subgroup analysis, the odds of ward cardiac arrest increased with each decrease in the number of medical ICU beds available (OR= 1.26 [95% CI, 1.06–1.49], p=0.01).
Conclusions
Reduced ICU bed availability is associated with increased rates of ICU readmission and ward cardiac arrest. This suggests that systemic factors are associated with patient outcomes and flexible critical care resources may be needed when demand is high.
doi:10.1097/CCM.0000000000000401
PMCID: PMC4134732  PMID: 24776607
in-hospital cardiac arrest; intensive care unit; patient readmission
14.  Implementation, reliability testing, and compliance monitoring of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in trauma patients 
Intensive care medicine  2008;34(7):1263-1268.
Objective
To implement delirium monitoring, test reliability, and monitor compliance of performing the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in trauma patients.
Design and setting
Prospective, observational study in a Level 1 trauma unit of a tertiary care, university-based medical center.
Patients
Acutely injured patients admitted to the trauma unit from February 1, 2006–April 16, 2006.
Measurements and Results
Following web-based teaching modules and group in-services, bedside nurses evaluated patients daily for depth of sedation with the Richmond Agitation-Sedation Scale (RASS) and for the presence of delirium with the CAM-ICU. On randomly assigned days over a 10-week period, evaluations by nursing staff were followed by evaluations by an expert evaluator of the RASS and the CAM-ICU, in order to assess compliance and reliability of the CAM-ICU in trauma patients. Following the audit period, the nurses completed a post-implementation survey.
One thousand and eleven random CAM-ICU assessments were performed by the expert evaluator, within 1 hour of the bedside nurses’ assessments. Nurses completed the CAM-ICU assessments in 84% (849 of 1011) of evaluations. Overall agreement (κ) between nurses and the expert evaluator was 0.77 (0.721, 0.822; p<0.0001). In TBI patients κ was 0.75 (0.667, 0.829; p<0.0001), while in mechanically-ventilated patients κ was 0.62 (0.534, 0.704; p<0.0001). The survey revealed nurses were confident in performing the CAM-ICU, realized the importance of delirium, and were satisfied with the training they received. The survey also acknowledged obstacles to implementation including nursing time and failure of physicians/surgeons to address treatment approaches for delirium.
Conclusions
The CAM-ICU can be successfully implemented in a university-based trauma unit with high compliance and reliability. Quality improvement projects seeking to implement delirium monitoring would be wise to address potential pitfalls including time complaints and the negative impact of physician indifference regarding this form of organ dysfunction.
doi:10.1007/s00134-008-1031-x
PMCID: PMC3773486  PMID: 18297270
delirium; trauma; critical care; implementation; monitoring; Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
15.  Nursing Workload in Intensive Care Unit Trauma Patients: Analysis of Associated Factors 
PLoS ONE  2014;9(11):e112125.
Background
From the perspective of nurses, trauma patients in the Intensive Care Unit (ICU) demand a high degree of nursing workload due to hemodynamic instability and the severity of trauma injuries. This study aims to identify the factors related to the high nursing workload required for trauma victims admitted to the ICU.
Methods
This is a prospective, cross-sectional study using descriptive and correlation analyses, conducted with 200 trauma patients admitted to an ICU in the city of São Paulo, Brazil. The nursing workload was measured using the Nursing Activities Score (NAS). The distribution of the NAS values into tertiles led to the identification of two research groups: medium/low workload and high workload. The Chi-square, Fisher's exact, Mann-Whitney and multiple logistic regression tests were utilized for the analyses.
Findings
The majority of patients were male (82.0%) and suffered blunt trauma (94.5%), with traffic accidents (57.5%) and falls (31.0%) being prevalent. The mean age was 40.7 years (±18.6) and the mean NAS was 71.3% (±16.9). Patient gender, the presence of pulmonary failure, the number of injured body regions and the risk of death according to the Simplified Acute Physiology Score II were factors associated with a high degree of nursing workload in the first 24 hours following admission to the ICU.
Conclusion
Workload demand was higher in male patients with physiological instability and multiple severe trauma injuries who developed pulmonary failure.
doi:10.1371/journal.pone.0112125
PMCID: PMC4223038  PMID: 25375369
16.  Do positive relations with patients play a protective role for healthcare employees? Effects of patients' gratitude and support on nurses' burnout 
Background: A growing number of studies reveal that there are significant associations between a patient's perception of quality of care and a health professional's perceived quality of work life. Previous studies focused on the patients or on the workers. Alternatively, they center the discussion on either the negative or the positive effects, both on patients and care workers. This research work focuses on the positive relationship with patients—a possible resource for care workers.
Method: Study 1: A CFA was conducted to test the factorial structure and the tenure of the Italian version for patients of the Customer-initiated Support scale. Study 2: Using a multi-group path analysis, the effects of work characteristics and of the relationship with patients on burnout were tested in two different contexts: emergency and oncology ward.
Results: Study 1: The one-factor instrument shows good reliability, convergent, and divergent validity. Study 2: for oncology nurses cognitive demands, job autonomy, and support from patients have direct effects on emotional exhaustion and job autonomy; interactions between cognitive demands and patients' support have an effect on depersonalization. For emergency nurses cognitive demands and interactions between job autonomy and support from patients have effects on emotional exhaustion; job autonomy, patients support and gratitude have direct effects on personal accomplishment.
Conclusions: Results confirm expectations about the role of patients' support and gratitude in reducing nurses' burnout, with differences in the two contexts: emergency nurses show higher burnout and lower perception of positive relationship with patients, but present more intense protective effects of the interaction between job autonomy and support/gratitude. Suggestions can be offered to managers in developing interventions to promote “healthy organization” culture that consider jointly employees and patients' needs.
doi:10.3389/fpsyg.2015.00470
PMCID: PMC4404725  PMID: 25954227
patients' gratitude; patients' support; burnout; SEM; nurses
17.  Effectiveness of a Home-Based Counselling Strategy on Neonatal Care and Survival: A Cluster-Randomised Trial in Six Districts of Rural Southern Tanzania 
PLoS Medicine  2015;12(9):e1001881.
Background
We report a cluster-randomised trial of a home-based counselling strategy, designed for large-scale implementation, in a population of 1.2 million people in rural southern Tanzania. We hypothesised that the strategy would improve neonatal survival by around 15%.
Methods and Findings
In 2010 we trained 824 female volunteers to make three home visits to women and their families during pregnancy and two visits to them in the first few days of the infant’s life in 65 wards, selected randomly from all 132 wards in six districts in Mtwara and Lindi regions, constituting typical rural areas in Southern Tanzania. The remaining wards were comparison areas. Participants were not blinded to the intervention. The primary analysis was an intention-to-treat analysis comparing the neonatal mortality (day 0–27) per 1,000 live births in intervention and comparison wards based on a representative survey in 185,000 households in 2013 with a response rate of 90%. We included 24,381 and 23,307 live births between July 2010 and June 2013 and 7,823 and 7,555 live births in the last year in intervention and comparison wards, respectively. We also compared changes in neonatal mortality and newborn care practices in intervention and comparison wards using baseline census data from 2007 including 225,000 households and 22,243 births in five of the six intervention districts. Amongst the 7,823 women with a live birth in the year prior to survey in intervention wards, 59% and 41% received at least one volunteer visit during pregnancy and postpartum, respectively. Neonatal mortality reduced from 35.0 to 30.5 deaths per 1,000 live births between 2007 and 2013 in the five districts, respectively. There was no evidence of an impact of the intervention on neonatal survival (odds ratio [OR] 1.1, 95% confidence interval [CI] 0.9–1.2, p = 0.339). Newborn care practices reported by mothers were better in intervention than in comparison wards, including immediate breastfeeding (42% of 7,287 versus 35% of 7,008, OR 1.4, CI 1.3–1.6, p < 0.001), feeding only breast milk for the first 3 d (90% of 7,557 versus 79% of 7,307, OR 2.2, 95% CI 1.8–2.7, p < 0.001), and clean hands for home delivery (92% of 1,351 versus 88% of 1,799, OR 1.5, 95% CI 1.0–2.3, p = 0.033). Facility delivery improved dramatically in both groups from 41% of 22,243 in 2007 and was 82% of 7,820 versus 75% of 7,553 (OR 1.5, 95% CI 1.2–2.0, p = 0.002) in intervention and comparison wards in 2013. Methodological limitations include our inability to rule out some degree of leakage of the intervention into the comparison areas and response bias for newborn care behaviours.
Conclusion
Neonatal mortality remained high despite better care practices and childbirth in facilities becoming common. Public health action to improve neonatal survival in this setting should include a focus on improving the quality of facility-based childbirth care.
Trial Registration
ClinicalTrials.gov NCT01022788
Editors' Summary
Background
In 1990, 12 million children—most of them living in resource-limited countries—died before their fifth birthday. Faced with this largely avoidable loss of young lives, in 2000, world leaders set a target of reducing under-five mortality (deaths) to one-third of its 1990 level by 2015 as Millennium Development Goal 4 (MDG4); this goal, together with seven others, aims to eradicate extreme poverty globally. Progress towards reducing under-five mortality has been good. However, MDG4 has not been met because of slow progress in reducing neonatal mortality—death during the first 28 days of life. In sub-Saharan Africa, for example, mortality during the first five years of life fell by 47% between 1990 and 2012, whereas neonatal mortality fell by only 28%. Consequently, neonatal deaths now account for a greater proportion of global child deaths than in 1990, and every year there are still 3 million neonatal deaths.
Why Was This Study Done?
Experts estimate that advising mothers during pregnancy and in the days following delivery (the early postpartum period) about good delivery and newborn care practices could prevent a quarter of neonatal deaths. WHO and the United Nations Children's Fund (UNICEF) therefore recommend that all mothers in areas with high neonatal mortality should receive two home visits during the early postpartum period to assess the newborn’s health and to counsel mothers on newborn care practices. In this cluster randomized trial, the researchers investigate the effect on neonatal care and survival in rural southern Tanzania, a low-resource setting, of a volunteer-led home-based counseling strategy that meets these recommendations. The neonatal mortality rate (NMR) has declined markedly in recent years in Tanzania but varies widely across the country. A cluster randomized trial randomly assigns groups of people (here, women living in different “wards” consisting of three or four villages) to receive alternative interventions and compares outcomes in the differently treated “clusters.”
What Did the Researchers Do and Find?
The researchers estimated baseline neonatal mortality in five rural districts in southern Tanzania (35 deaths per 1,000 live births) from a 2007 census. In early 2010, they trained 824 female volunteers to deliver key counseling messages (including messages about handwashing with soap before delivery and early and exclusive breast feeding) and supporting messages such as the importance of childbirth in a health care facility. The volunteers were asked to make three home visits during pregnancy and two home visits shortly after delivery to women living in 65 intervention wards in six rural Tanzanian districts (a district not included in the baseline census was included in the trial); 67 comparison wards did not receive the intervention. A 2013 survey of households indicated that, in the intervention wards, 59% of women received at least one volunteer visit during pregnancy and 41% received at least one visit postpartum. Neonatal mortality reduced from 35 to 31 and 30 deaths per 1,000 live births in the intervention and comparison wards, respectively, in the five districts with baseline data. Newborn care practices reported by mothers were better in the intervention wards than in the comparison wards. For example, 42% and 35% of the women in the intervention and comparison wards, respectively, reported immediate breast feeding. Finally, childbirth in a health care facility increased from 41% in 2007 to 82% and 75% in 2013 in the intervention and comparison wards, respectively.
What Do These Findings Mean?
These findings provide no evidence for an effect on neonatal survival of the home-based counseling strategy tested here even though the intervention improved newborn care practices. Notably, although many of the women in the intervention wards received antenatal visits from the trained volunteers, fewer women received early postpartum visits, a finding that could be partly responsible for the lack of effectiveness of the intervention. The accuracy of these findings may be limited by certain aspects of the trial design. For example, some of the women in the comparison areas may have inadvertently received part of the intervention (“leakage”). In addition, newborn care practises improved much in both, intervention and comparison areas, included a doubling of facility delivery. Nevertheless, the lack of an effect of the intervention on neonatal mortality despite a moderate effect on newborn care behaviours throws some doubt on the existing evidence base in support of home-based counselling as an intervention to reduce neonatal mortality. Finally, the finding that childbirth in a health care facility increased during the study period without a concomitant reduction in neonatal mortality highlights the need to improve the quality of facility-based childbirth care in rural southern Tanzania and, possibly, in other resource-limited settings.
Additional Information
This list of resources contains links that can be accessed when viewing the PDF on a device or via the online version of the article at http://dx.doi.org/10.1371/journal.pmed.1001881.
WHO provides information on global efforts to reduce child mortality and on ending preventable neonatal deaths (available in several languages); its 2009 recommendations, "Home Visits for the Newborn Child. A Strategy to Improve Survival," are available
UNICEF works for children’s rights, survival, development, and protection around the world; it provides information about MDG4 and about child health in Tanzania; its website provides detailed statistics about child health; its Committing to Child Survival: A Promise Renewed—Progress Report 2014 addresses neonatal mortality
The Millennium Development Goals 2015 Report is available
The Healthy Newborn Network is an online community of more than 80 partner organizations that addresses critical knowledge gaps in newborn health
More information about the trial described here is available
doi:10.1371/journal.pmed.1001881
PMCID: PMC4587813  PMID: 26418813
18.  Association between increased blood interleukin-6 levels on emergency department arrival and prolonged length of intensive care unit stay for blunt trauma 
Background
Systemic immune response to injury plays a key role in the pathophysiological mechanism of blunt trauma. We tested the hypothesis that increased blood interleukin-6 (IL-6) levels of blunt trauma patients on emergency department (ED) arrival are associated with poor clinical outcomes, and investigated the utility of rapid measurement of the blood IL-6 level.
Methods
We enrolled 208 consecutive trauma patients who were transferred from the scene of an accident to a level I trauma centre in Japan and admitted to the intensive care unit (ICU). Blood IL-6 levels on ED arrival were measured by using a rapid measurement assay. The primary outcome variable was prolonged ICU stay (length of ICU stay > 7 days). The secondary outcomes were 28-day mortality, probability of survival and Abbreviated Injury Scale (AIS) scores.
Results
Patients with prolonged ICU stay had significantly higher blood IL-6 levels on ED arrival than the patients without prolonged ICU stay (P < 0.0001). The receiver-operating characteristic curves produced an area under the curve of 0.75 (95 % confidence interval [CI], 0.66–0.84; P < 0.0001) for prolonged ICU stay. The patients who had increased blood IL-6 levels on ED arrival had increased 28-day mortality (P = 0.021) and decreased probability of survival (P < 0.0001). The AIS scores for the thorax, abdomen, extremity, and external body regions independently correlated with blood IL-6 levels (unstandardized coefficients [95 % CI] for the thorax: 23.8 [12.6–35.1]; P < 0.0001; abdomen: 42.7 [23.8–61.7]; P < 0.0001; extremity: 19.0 [5.5–32.4]; P = 0.0060; external body regions: 62.9 [13.2–112.7]; P = 0.030); the standardized coefficients for the thorax (0.27) and abdomen (0.28) were larger than those for the extremity (0.18) and external body regions (0.15).
Conclusions
Increased blood IL-6 level on ED arrival was significantly associated with prolonged length of ICU stay. Blood IL-6 level on ED arrival independently correlated with the AIS scores for the abdomen and thorax, and, to a lesser extent, those for the extremity and external body regions. The rapid measurement of blood IL-6 level on ED arrival can be utilized as a fast screening tool to improve assessment of injury severity and prediction of clinical outcomes in the initial phase of trauma care.
doi:10.1186/s13017-016-0063-8
PMCID: PMC4727350  PMID: 26816526
Blunt trauma; Interleukin-6; Abbreviated Injury Scale; Injury Severity Score; Trauma and Injury Severity Score
19.  An Economic Evaluation of Venous Thromboembolism Prophylaxis Strategies in Critically Ill Trauma Patients at Risk of Bleeding 
PLoS Medicine  2009;6(6):e1000098.
Using decision analysis, Henry Stelfox and colleagues estimate the cost-effectiveness of three venous thromboembolism prophylaxis strategies in patients with severe traumatic injuries who were also at risk for bleeding complications.
Background
Critically ill trauma patients with severe injuries are at high risk for venous thromboembolism (VTE) and bleeding simultaneously. Currently, the optimal VTE prophylaxis strategy is unknown for trauma patients with a contraindication to pharmacological prophylaxis because of a risk of bleeding.
Methods and Findings
Using decision analysis, we estimated the cost effectiveness of three VTE prophylaxis strategies—pneumatic compression devices (PCDs) and expectant management alone, serial Doppler ultrasound (SDU) screening, and prophylactic insertion of a vena cava filter (VCF)—in trauma patients admitted to an intensive care unit (ICU) with severe injuries who were believed to have a contraindication to pharmacological prophylaxis for up to two weeks because of a risk of major bleeding. Data on the probability of deep vein thrombosis (DVT) and pulmonary embolism (PE), and on the effectiveness of the prophylactic strategies, were taken from observational and randomized controlled studies. The probabilities of in-hospital death, ICU and hospital discharge rates, and resource use were taken from a population-based cohort of trauma patients with severe injuries (injury severity scores >12) admitted to the ICU of a regional trauma centre. The incidence of DVT at 12 weeks was similar for the PCD (14.9%) and SDU (15.0%) strategies, but higher for the VCF (25.7%) strategy. Conversely, the incidence of PE at 12 weeks was highest in the PCD strategy (2.9%), followed by the SDU (1.5%) and VCF (0.3%) strategies. Expected mortality and quality-adjusted life years were nearly identical for all three management strategies. Expected health care costs at 12 weeks were Can$55,831 for the PCD strategy, Can$55,334 for the SDU screening strategy, and Can$57,377 for the VCF strategy, with similar trends noted over a lifetime analysis.
Conclusions
The attributable mortality due to PE in trauma patients with severe injuries is low relative to other causes of mortality. Prophylactic placement of VCF in patients at high risk of VTE who cannot receive pharmacological prophylaxis is expensive and associated with an increased risk of DVT. Compared to the other strategies, SDU screening was associated with better clinical outcomes and lower costs.
Please see later in the article for Editors' Summary
Editors' Summary
Background
For patients who have been seriously injured in an accident or a violent attack (trauma patients), venous thromboembolism (VTE)—the formation of blood clots that limit the flow of blood through the veins—is a frequent and potentially fatal complication. The commonest form of VTE is deep vein thrombosis (DVT). “Distal” DVTs (clots that form in deep veins below the knee) affect about half of patients with severe trauma; “proximal” DVTs (clots that form above the knee) develop in one in five trauma patients. DVTs cause pain and swelling in the affected leg and can leave patients with a painful condition called post-thrombotic syndrome. Worse still, part of the clot can break off and travel to the lungs where it can cause a life-threatening pulmonary embolism (PE). Distal DVTs rarely embolize but, if untreated, half of patients who present with a proximal DVT will develop a PE, and 2%–3% of them will die as a result.
Why Was This Study Done?
VTE is usually prevented by using heparin, a drug that stops blood clotting, but clinicians treating critically ill trauma patients have a dilemma. Many of these patients are at high risk of serious bleeding complications so cannot be given heparin to prevent VTE. Nonpharmacological ways to prevent VTE include the use of pneumatic compression devices to keep the blood moving in the legs (clots often form in patients confined to bed because of the sluggish blood flow in their legs), repeated screening for blood clots using Doppler ultrasound, and the insertion of a “vena cava filter” into the vein that takes blood from the legs to the heart. This last device catches blood clots before they reach the lungs but increases the risk of DVT. Unfortunately, no-one knows which VTE prevention strategy works best in trauma patients who cannot be given heparin. In this study, therefore, the researchers use decision analysis (the systematic evaluation of the most important factors affecting a decision) to estimate the costs and likely clinical outcomes of these strategies.
What Did the Researchers Do and Find?
The researchers used cost and clinical data from patients admitted to a Canadian trauma center with severe head/neck and/or abdomen/pelvis injuries (patients with a high risk of bleeding complications likely to make heparin therapy dangerous for up to two weeks after the injury) to construct a Markov decision analysis model. They then fed published data on the chances of patients developing DVT or PE, and on the effectiveness of the three VTE prevention strategies, into the model to obtain estimates of the costs and clinical outcomes of the strategies at 12 weeks after the injury and over the patients' lifetime. The estimated incidence of DVT at 12 weeks was 15% for the pneumatic compression device and Doppler ultrasound strategies, but 25% for the vena cava filter strategy. By contrast, the estimated incidence of PE was 2.9% with the pneumatic compression device, 1.5% with Doppler ultrasound, but only 0.3% with the vena cava filter. The expected mortality with all three strategies was similar. Finally, the estimated health care costs per patient at 12 weeks were Can$55,334 and Can$55,831 for the Doppler ultrasound and pneumatic compression device strategies, respectively, but Can$57,377 for the vena cava filter strategy; similar trends were seen for lifetime health care costs.
What Do These Findings Mean?
As with all mathematical models, these findings depend on the data fed into the model and on the assumptions included in it. For example, because data from one Canadian trauma unit were used to construct the model, these findings may not be generalizable. Nevertheless, these findings suggest that, although VTE is common among patients with severe injuries, PE is not a major cause of death among these patients. They also suggest that the use of vena cava filters for VTE prevention in patients who cannot receive heparin should not be routinely used because it is expensive and increases the risk of DVT. Finally, these results suggest that, compared with the other strategies, serial Doppler ultrasound is associated with better clinical outcomes and lower costs.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000098.
The US National Heart Lung and Blood Institute provides information (including an animation) on deep vein thrombosis and pulmonary embolism
MedlinePlus provides links to more information about deep vein thrombosis and pulmonary embolism (in several languages)
The UK National Health Service Choices Web site has information on deep vein thrombosis and on embolism (in English and Spanish)
The Eastern Association for the Surgery of Trauma working group document Practice Management Guidelines for the Management of Venous Thromboembolism in Trauma Patients can be downloaded from the Internet
doi:10.1371/journal.pmed.1000098
PMCID: PMC2695771  PMID: 19554085
20.  CHARACTERISTICS AND OUTCOME OF STROKE PATIENTS WITH CEREBROVASCULAR ACCIDENT AT THE INTENSIVE CARE UNIT OF A TERTIARY HOSPITAL IN NIGERIA  
Abstract
Background: Patients with severe stroke defined as NIHSS score >17 constituting about 15-20% of cerebrovascular accident require admission into the Intensive Care Unit (ICU). However the benefit of ICU admission for stroke patients remains controversial.
Aim & Objectives: To determine the characteristics and outcome of patients with cerebrovascular accident managed at the Intensive Care Unit of University of Benin Teaching Hospital.
Methodology: Demographic characteristics, clinical features and course, treatment options and outcome of all stroke patients admitted in ICU from January 2002 to January 2012 were retrieved from the hospital records and analyzed. A patient before and after each stroke patient were selected as controls for the study. Primary outcome variable was ICU mortality, type of stroke whether ischemic or haemorrhagic, duration of stay, whether patients were transferred from the medical/stroke ward or from the accident and emergency department of the hospital.
Results: A total of thirty six (36) stroke patients were admitted into the ICU within the study period accounting for 5.6% of the total ICU admissions. The male: female ratio is 2:1 and patients aged >60 years accounted for 55.6%. Stroke patients admitted into ICU had a mortality rate of 77.8%. Patients with severe stroke admitted into the ICU were 4 times more likely to die compared to non-stroke patients in the ICU (p=0.002, OR=4.472). However, severe stroke had no significant impact on duration of ICU stay (p=0.454, OR=1.464).
Conclusion: Stroke patients have a high mortality in the intensive care unit that is independent on the type and route of admission. Provision of the support equipment and instruments required for high dependency service in the intensive care unit and early admission should improve the outcome.
PMCID: PMC4228813  PMID: 25453008
Severe cerebrovascular accident; ICU admission ; High mortality;  Nigeria
21.  Trauma admissions to the Intensive care unit at a reference hospital in Northwestern Tanzania 
Background
Major trauma has been reported to be a major cause of hospitalization and intensive care utilization worldwide and consumes a significant amount of the health care budget. The aim of this study was to describe the characteristics and treatment outcome of major trauma patients admitted into our ICU and to identify predictors of outcome.
Methods
Between January 2008 and December 2010, a descriptive prospective study of all trauma admissions to a multidisciplinary intensive care unit (ICU) of Bugando Medical Centre in Northwestern Tanzania was conducted.
Results
A total of 312 cases of major trauma were admitted in the ICU, representing 37.1% of the total ICU admissions. Males outnumbered females by a ratio of 5.5:1. Their median age was 27 years. Trauma admissions were almost exclusively emergencies (95.2%) and came mainly from the Accident and Emergency (60.6%) and Operating room (23.4%). Road traffic crash (RTC) was the most common cause of injuries affecting 70.8% of patients. Two hundred fourteen patients (68.6%) required surgical intervention. The overall ICU length of stay (LOS) for all trauma patients ranged from 1 to 59 days (median = 8 days). The median ICU length of hospital stay (LOS) for survivors and non-survivors were 8 and 5 days respectively. (P = 0.002). Mortality rate was 32.7%. Mortality rate of trauma patients was significantly higher than that of all ICU admissions (32.7% vs. 18.8%, P = 0.0012). According to multivariate logistic regression analysis, multiple injuries, severe head injuries and burns were responsible for a longer mean ICU stay (P < 0.001) whereas admission Glasgow Coma Score < 9, systolic blood pressure < 90 mmHg, injury severity core >16, prolonged duration of loss of consciousness, delayed ICU admission (0.028), the need for ventilatory support and finding of space occupying lesion on computed tomography scan significantly influenced mortality (P < 0.001).
Conclusion
Trauma resulting from road traffic crashes is a leading cause of intensive care utilization in our hospital. Urgent preventive measures targeting at reducing the occurrence of RTCs is necessary to reduce ICU trauma admissions in this region. Improved pre- and in-hospital care of trauma victims will improve the outcome of trauma patients admitted to our ICU.
doi:10.1186/1757-7241-19-61
PMCID: PMC3214823  PMID: 22024353
Intensive care unit; trauma admissions; prevalence; injury characteristics; outcome; Tanzania
22.  Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices 
Executive Summary
Objective
The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions.
Clinical Need: Condition and Target Population
Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD.
Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities.
Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs.
Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices.
With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications.
In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs.
Technology
In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings.
Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system.
Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented.
Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians.
The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers—Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.—which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices.
All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience.
Research Questions
The research directions and specific research questions for this evidence review were as follows:
To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices.
To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs.
To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices.
To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies.
To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada.
Research Methods
Literature Search
The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices.
Search Strategy
A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
published between 1950 and September 2010;
English language full-reports and human studies;
original reports including clinical evaluations of Internet-based device-assisted RMSs for CIEDs in clinical settings;
reports including standardized measurements on outcome events such as technical success, safety, effectiveness, cost, measures of health care utilization, morbidity, mortality, quality of life or patient satisfaction;
randomized controlled trials (RCTs), systematic reviews and meta-analyses, cohort and controlled clinical studies.
Exclusion Criteria
non-systematic reviews, letters, comments and editorials;
reports not involving standardized outcome events;
clinical reports not involving Internet-based device assisted RM systems for CIEDs in clinical settings;
reports involving studies testing or validating algorithms without RM;
studies with small samples (<10 subjects).
Outcomes of Interest
The outcomes of interest included: technical outcomes, emergency department visits, complications, major adverse events, symptoms, hospital admissions, clinic visits (scheduled and/or unscheduled), survival, morbidity (disease progression, stroke, etc.), patient satisfaction, and quality of life.
Summary of Findings
The MAS evidence review was performed to review available evidence on Internet-based device-assisted RMSs for CIEDs published until September 2010. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies—3 of these being registry-based and 4 being multi-centered. The evidence is summarized in the 3 sections that follow.
1. Effectiveness of Remote Monitoring Systems of CIEDs for Cardiac Arrhythmia and Device Functioning
In total, 15 reports on 13 cohort studies involving investigations with 4 different RMSs for CIEDs in cardiology implant clinic groups were identified in the review. The 4 RMSs were: Care Link Network® (Medtronic Inc,, Minneapolis, MN, USA); Home Monitoring® (Biotronic, Berlin, Germany); House Call 11® (St Jude Medical Inc., St Pauls, MN, USA); and a manufacturer-independent RMS. Eight of these reports were with the Home Monitoring® RMS (12,949 patients), 3 were with the Care Link® RMS (167 patients), 1 was with the House Call 11® RMS (124 patients), and 1 was with a manufacturer-independent RMS (44 patients). All of the studies, except for 2 in the United States, (1 with Home Monitoring® and 1 with House Call 11®), were performed in European countries.
The RMSs in the studies were evaluated with different cardiac implant device populations: ICDs only (6 studies), ICD and CRT devices (3 studies), PM and ICD and CRT devices (4 studies), and PMs only (2 studies). The patient populations were predominately male (range, 52%–87%) in all studies, with mean ages ranging from 58 to 76 years. One study population was unique in that RMSs were evaluated for ICDs implanted solely for primary prevention in young patients (mean age, 44 years) with Brugada syndrome, which carries an inherited increased genetic risk for sudden heart attack in young adults.
Most of the cohort studies reported on the feasibility of RMSs in clinical settings with limited follow-up. In the short follow-up periods of the studies, the majority of the events were related to detection of medical events rather than system configuration or device abnormalities. The results of the studies are summarized below:
The interrogation of devices on the web platform, both for continuous and scheduled transmissions, was significantly quicker with remote follow-up, both for nurses and physicians.
In a case-control study focusing on a Brugada population–based registry with patients followed-up remotely, there were significantly fewer outpatient visits and greater detection of inappropriate shocks. One death occurred in the control group not followed remotely and post-mortem analysis indicated early signs of lead failure prior to the event.
Two studies examined the role of RMSs in following ICD leads under regulatory advisory in a European clinical setting and noted:
– Fewer inappropriate shocks were administered in the RM group.
– Urgent in-office interrogations and surgical revisions were performed within 12 days of remote alerts.
– No signs of lead fracture were detected at in-office follow-up; all were detected at remote follow-up.
Only 1 study reported evaluating quality of life in patients followed up remotely at 3 and 6 months; no values were reported.
Patient satisfaction was evaluated in 5 cohort studies, all in short term follow-up: 1 for the Home Monitoring® RMS, 3 for the Care Link® RMS, and 1 for the House Call 11® RMS.
– Patients reported receiving a sense of security from the transmitter, a good relationship with nurses and physicians, positive implications for their health, and satisfaction with RM and organization of services.
– Although patients reported that the system was easy to implement and required less than 10 minutes to transmit information, a variable proportion of patients (range, 9% 39%) reported that they needed the assistance of a caregiver for their transmission.
– The majority of patients would recommend RM to other ICD patients.
– Patients with hearing or other physical or mental conditions hindering the use of the system were excluded from studies, but the frequency of this was not reported.
Physician satisfaction was evaluated in 3 studies, all with the Care Link® RMS:
– Physicians reported an ease of use and high satisfaction with a generally short-term use of the RMS.
– Physicians reported being able to address the problems in unscheduled patient transmissions or physician initiated transmissions remotely, and were able to handle the majority of the troubleshooting calls remotely.
– Both nurses and physicians reported a high level of satisfaction with the web registry system.
2. Effectiveness of Remote Monitoring Systems in Heart Failure Patients for Cardiac Arrhythmia and Heart Failure Episodes
Remote follow-up of HF patients implanted with ICD or CRT devices, generally managed in specialized HF clinics, was evaluated in 3 cohort studies: 1 involved the Home Monitoring® RMS and 2 involved the Care Link® RMS. In these RMSs, in addition to the standard diagnostic features, the cardiac devices continuously assess other variables such as patient activity, mean heart rate, and heart rate variability. Intra-thoracic impedance, a proxy measure for lung fluid overload, was also measured in the Care Link® studies. The overall diagnostic performance of these measures cannot be evaluated, as the information was not reported for patients who did not experience intra-thoracic impedance threshold crossings or did not undergo interventions. The trial results involved descriptive information on transmissions and alerts in patients experiencing high morbidity and hospitalization in the short study periods.
3. Comparative Effectiveness of Remote Monitoring Systems for CIEDs
Seven RCTs were identified evaluating RMSs for CIEDs: 2 were for PMs (1276 patients) and 5 were for ICD/CRT devices (3733 patients). Studies performed in the clinical setting in the United States involved both the Care Link® RMS and the Home Monitoring® RMS, whereas all studies performed in European countries involved only the Home Monitoring® RMS.
3A. Randomized Controlled Trials of Remote Monitoring Systems for Pacemakers
Two trials, both multicenter RCTs, were conducted in different countries with different RMSs and study objectives. The PREFER trial was a large trial (897 patients) performed in the United States examining the ability of Care Link®, an Internet-based remote PM interrogation system, to detect clinically actionable events (CAEs) sooner than the current in-office follow-up supplemented with transtelephonic monitoring transmissions, a limited form of remote device interrogation. The trial results are summarized below:
In the 375-day mean follow-up, 382 patients were identified with at least 1 CAE—111 patients in the control arm and 271 in the remote arm.
The event rate detected per patient for every type of CAE, except for loss of atrial capture, was higher in the remote arm than the control arm.
The median time to first detection of CAEs (4.9 vs. 6.3 months) was significantly shorter in the RMS group compared to the control group (P < 0.0001).
Additionally, only 2% (3/190) of the CAEs in the control arm were detected during a transtelephonic monitoring transmission (the rest were detected at in-office follow-ups), whereas 66% (446/676) of the CAEs were detected during remote interrogation.
The second study, the OEDIPE trial, was a smaller trial (379 patients) performed in France evaluating the ability of the Home Monitoring® RMS to shorten PM post-operative hospitalization while preserving the safety of conventional management of longer hospital stays.
Implementation and operationalization of the RMS was reported to be successful in 91% (346/379) of the patients and represented 8144 transmissions.
In the RM group 6.5% of patients failed to send messages (10 due to improper use of the transmitter, 2 with unmanageable stress). Of the 172 patients transmitting, 108 patients sent a total of 167 warnings during the trial, with a greater proportion of warnings being attributed to medical rather than technical causes.
Forty percent had no warning message transmission and among these, 6 patients experienced a major adverse event and 1 patient experienced a non-major adverse event. Of the 6 patients having a major adverse event, 5 contacted their physician.
The mean medical reaction time was faster in the RM group (6.5 ± 7.6 days vs. 11.4 ± 11.6 days).
The mean duration of hospitalization was significantly shorter (P < 0.001) for the RM group than the control group (3.2 ± 3.2 days vs. 4.8 ± 3.7 days).
Quality of life estimates by the SF-36 questionnaire were similar for the 2 groups at 1-month follow-up.
3B. Randomized Controlled Trials Evaluating Remote Monitoring Systems for ICD or CRT Devices
The 5 studies evaluating the impact of RMSs with ICD/CRT devices were conducted in the United States and in European countries and involved 2 RMSs—Care Link® and Home Monitoring ®. The objectives of the trials varied and 3 of the trials were smaller pilot investigations.
The first of the smaller studies (151 patients) evaluated patient satisfaction, achievement of patient outcomes, and the cost-effectiveness of the Care Link® RMS compared to quarterly in-office device interrogations with 1-year follow-up.
Individual outcomes such as hospitalizations, emergency department visits, and unscheduled clinic visits were not significantly different between the study groups.
Except for a significantly higher detection of atrial fibrillation in the RM group, data on ICD detection and therapy were similar in the study groups.
Health-related quality of life evaluated by the EuroQoL at 6-month or 12-month follow-up was not different between study groups.
Patients were more satisfied with their ICD care in the clinic follow-up group than in the remote follow-up group at 6-month follow-up, but were equally satisfied at 12- month follow-up.
The second small pilot trial (20 patients) examined the impact of RM follow-up with the House Call 11® system on work schedules and cost savings in patients randomized to 2 study arms varying in the degree of remote follow-up.
The total time including device interrogation, transmission time, data analysis, and physician time required was significantly shorter for the RM follow-up group.
The in-clinic waiting time was eliminated for patients in the RM follow-up group.
The physician talk time was significantly reduced in the RM follow-up group (P < 0.05).
The time for the actual device interrogation did not differ in the study groups.
The third small trial (115 patients) examined the impact of RM with the Home Monitoring® system compared to scheduled trimonthly in-clinic visits on the number of unplanned visits, total costs, health-related quality of life (SF-36), and overall mortality.
There was a 63.2% reduction in in-office visits in the RM group.
Hospitalizations or overall mortality (values not stated) were not significantly different between the study groups.
Patient-induced visits were higher in the RM group than the in-clinic follow-up group.
The TRUST Trial
The TRUST trial was a large multicenter RCT conducted at 102 centers in the United States involving the Home Monitoring® RMS for ICD devices for 1450 patients. The primary objectives of the trial were to determine if remote follow-up could be safely substituted for in-office clinic follow-up (3 in-office visits replaced) and still enable earlier physician detection of clinically actionable events.
Adherence to the protocol follow-up schedule was significantly higher in the RM group than the in-office follow-up group (93.5% vs. 88.7%, P < 0.001).
Actionability of trimonthly scheduled checks was low (6.6%) in both study groups. Overall, actionable causes were reprogramming (76.2%), medication changes (24.8%), and lead/system revisions (4%), and these were not different between the 2 study groups.
The overall mean number of in-clinic and hospital visits was significantly lower in the RM group than the in-office follow-up group (2.1 per patient-year vs. 3.8 per patient-year, P < 0.001), representing a 45% visit reduction at 12 months.
The median time from onset of first arrhythmia to physician evaluation was significantly shorter (P < 0.001) in the RM group than in the in-office follow-up group for all arrhythmias (1 day vs. 35.5 days).
The median time to detect clinically asymptomatic arrhythmia events—atrial fibrillation (AF), ventricular fibrillation (VF), ventricular tachycardia (VT), and supra-ventricular tachycardia (SVT)—was also significantly shorter (P < 0.001) in the RM group compared to the in-office follow-up group (1 day vs. 41.5 days) and was significantly quicker for each of the clinical arrhythmia events—AF (5.5 days vs. 40 days), VT (1 day vs. 28 days), VF (1 day vs. 36 days), and SVT (2 days vs. 39 days).
System-related problems occurred infrequently in both groups—in 1.5% of patients (14/908) in the RM group and in 0.7% of patients (3/432) in the in-office follow-up group.
The overall adverse event rate over 12 months was not significantly different between the 2 groups and individual adverse events were also not significantly different between the RM group and the in-office follow-up group: death (3.4% vs. 4.9%), stroke (0.3% vs. 1.2%), and surgical intervention (6.6% vs. 4.9%), respectively.
The 12-month cumulative survival was 96.4% (95% confidence interval [CI], 95.5%–97.6%) in the RM group and 94.2% (95% confidence interval [CI], 91.8%–96.6%) in the in-office follow-up group, and was not significantly different between the 2 groups (P = 0.174).
The CONNECT Trial
The CONNECT trial, another major multicenter RCT, involved the Care Link® RMS for ICD/CRT devices in a15-month follow-up study of 1,997 patients at 133 sites in the United States. The primary objective of the trial was to determine whether automatically transmitted physician alerts decreased the time from the occurrence of clinically relevant events to medical decisions. The trial results are summarized below:
Of the 575 clinical alerts sent in the study, 246 did not trigger an automatic physician alert. Transmission failures were related to technical issues such as the alert not being programmed or not being reset, and/or a variety of patient factors such as not being at home and the monitor not being plugged in or set up.
The overall mean time from the clinically relevant event to the clinical decision was significantly shorter (P < 0.001) by 17.4 days in the remote follow-up group (4.6 days for 172 patients) than the in-office follow-up group (22 days for 145 patients).
– The median time to a clinical decision was shorter in the remote follow-up group than in the in-office follow-up group for an AT/AF burden greater than or equal to 12 hours (3 days vs. 24 days) and a fast VF rate greater than or equal to 120 beats per minute (4 days vs. 23 days).
Although infrequent, similar low numbers of events involving low battery and VF detection/therapy turned off were noted in both groups. More alerts, however, were noted for out-of-range lead impedance in the RM group (18 vs. 6 patients), and the time to detect these critical events was significantly shorter in the RM group (same day vs. 17 days).
Total in-office clinic visits were reduced by 38% from 6.27 visits per patient-year in the in-office follow-up group to 3.29 visits per patient-year in the remote follow-up group.
Health care utilization visits (N = 6,227) that included cardiovascular-related hospitalization, emergency department visits, and unscheduled clinic visits were not significantly higher in the remote follow-up group.
The overall mean length of hospitalization was significantly shorter (P = 0.002) for those in the remote follow-up group (3.3 days vs. 4.0 days) and was shorter both for patients with ICD (3.0 days vs. 3.6 days) and CRT (3.8 days vs. 4.7 days) implants.
The mortality rate between the study arms was not significantly different between the follow-up groups for the ICDs (P = 0.31) or the CRT devices with defribillator (P = 0.46).
Conclusions
There is limited clinical trial information on the effectiveness of RMSs for PMs. However, for RMSs for ICD devices, multiple cohort studies and 2 large multicenter RCTs demonstrated feasibility and significant reductions in in-office clinic follow-ups with RMSs in the first year post implantation. The detection rates of clinically significant events (and asymptomatic events) were higher, and the time to a clinical decision for these events was significantly shorter, in the remote follow-up groups than in the in-office follow-up groups. The earlier detection of clinical events in the remote follow-up groups, however, was not associated with lower morbidity or mortality rates in the 1-year follow-up. The substitution of almost all the first year in-office clinic follow-ups with RM was also not associated with an increased health care utilization such as emergency department visits or hospitalizations.
The follow-up in the trials was generally short-term, up to 1 year, and was a more limited assessment of potential longer term device/lead integrity complications or issues. None of the studies compared the different RMSs, particularly the different RMSs involving patient-scheduled transmissions or automatic transmissions. Patients’ acceptance of and satisfaction with RM were reported to be high, but the impact of RM on patients’ health-related quality of life, particularly the psychological aspects, was not evaluated thoroughly. Patients who are not technologically competent, having hearing or other physical/mental impairments, were identified as potentially disadvantaged with remote surveillance. Cohort studies consistently identified subgroups of patients who preferred in-office follow-up. The evaluation of costs and workflow impact to the health care system were evaluated in European or American clinical settings, and only in a limited way.
Internet-based device-assisted RMSs involve a new approach to monitoring patients, their disease progression, and their CIEDs. Remote monitoring also has the potential to improve the current postmarket surveillance systems of evolving CIEDs and their ongoing hardware and software modifications. At this point, however, there is insufficient information to evaluate the overall impact to the health care system, although the time saving and convenience to patients and physicians associated with a substitution of in-office follow-up by RM is more certain. The broader issues surrounding infrastructure, impacts on existing clinical care systems, and regulatory concerns need to be considered for the implementation of Internet-based RMSs in jurisdictions involving different clinical practices.
PMCID: PMC3377571  PMID: 23074419
23.  Admissions to intensive care units from emergency departments: a descriptive study 
Emergency Medicine Journal : EMJ  2005;22(6):423-428.
Objectives: To describe the case mix, activity, and outcome for admissions to intensive care units (ICUs) from emergency departments (EDs).
Design: An observational study using data from a high quality clinical database, the Case Mix Programme Database, of intensive care admissions, coordinated at the Intensive Care National Audit & Research Centre (ICNARC).
Setting: 91 adult ICUs in England, Wales, and Northern Ireland, 1996–99.
Subjects: 46 587 intensive care admissions.
Main outcome measures: Ultimate hospital mortality.
Results: Admissions from EDs constituted 26% of total admissions to ICU, 77% of which were direct admissions to ICU from EDs. Direct admissions from EDs, indirect admissions from EDs, and non-ED admissions presented to ICU with different conditions and severity of illness. Indirect admissions from EDs presented in the ICU with the more severe case mix (older age, more acute severity of illness, more likely to have a chronic illness) compared with direct admissions to ICU from EDs. Compared with ICU admissions not originating in EDs, unit and hospital mortality were higher for admissions from EDs, with indirect admissions experiencing the highest hospital (46.4%) mortality. For ICU survivors, indirect admissions stayed longest in the ICU.
Conclusions: A large proportion of admissions to ICU (26%) originate in EDs, and differ from those not originating in EDs in terms of both case mix and outcome. Additionally, those admitted directly to ICU from EDs differ from those admitted indirectly via a ward. The observed differences in outcome between different admission routes require further investigation and explanation.
doi:10.1136/emj.2003.005124
PMCID: PMC1726808  PMID: 15911950
24.  Assessment scales for delirium: A review 
World Journal of Psychiatry  2012;2(4):58-70.
Over the years many scales have been designed for screening, diagnosis and assessing the severity of delirium. In this paper we review the various instruments available to screen the patients for delirium, instruments available to diagnose delirium, assess the severity, cognitive functions, motoric subtypes, etiology and associated distress. Among the various screening instruments, NEECHAM confusion scale and delirium observation scale appear to be most suitable screening instrument for patients’ in general medical and surgical wards, depending on the type of rater (physician or nurse). In general, the instruments which are used for diagnosis [i.e., confusion assessment method (CAM), CAM for intensive care unit (CAM-ICU), Delirium Rating Scale-revised version (DRS-R-98), memorial selirium assessment scale, etc.] are based on various Diagnostic and Statistical Manual criteria and have good to excellent reliability and fair to good validity. Among the various diagnostic instruments, CAM is considered to be most useful instrument because of its accuracy, brevity, and ease of use by clinicians and lay interviewers. In contrast, DRS-R-98 appears to be a comprehensive instrument useful for diagnosis, severity rating and is sensitive to change and hence can be used for monitoring patients over a period. In the ICU setting, evidence suggests that CAM-ICU and Nursing Delirium Screening Scale had comparable sensitivities, but CAM-ICU has higher specificity. With regard to assessment of delirium in pediatric age group, certain instruments like Pediatric Anesthesia Emergence Delirium scale and pediatric CAM-ICU has been designed and have been found to be useful.
doi:10.5498/wjp.v2.i4.58
PMCID: PMC3782167  PMID: 24175169
Delirium; Screening; Diagnosis; Cognition
25.  Posttraumatic stress in intensive care unit survivors – a prospective study 
Aims: This study aimed to estimate the prevalence of severe Posttraumatic Stress Disorder (PTSD) symptoms and to identify factors associated with PTSD in survivors of intensive care unit (ICU) treatment following traumatic injury. Methods: Fifty-two patients who were admitted to an ICU through the emergency ward following traumatic injury were prospectively followed. Information on injury severity and ICU treatment were obtained through medical records. Demographic information and measures of acute stress symptoms, experienced social support, coping style, sense of coherence (SOC) and locus of control were assessed within one-month post-accident (T1). At the six months follow-up (T2), PTSD was assessed with the Harvard Trauma Questionnaire (HTQ). Results: In the six months follow-up, 10 respondents (19.2%) had HTQ total scores reaching a level suggestive of PTSD (N = 52), and 11 respondents (21%) had symptom levels indicating subclinical PTSD. Female, five illness factors: coma time, mechanical ventilation, sedation, benzodiazepine, pain relieving medication, and four psychological factors: symptoms of acute stress (T1), fear of death and/or feeling completely helpless and powerless in relation to the accident and/or ICU (T1), SOC (T1) and more external locus of control (T1) correlated significantly with PTSD symptoms at T2. In the linear regression analysis, female, length of sedation, dissociation (T1), hypervigilance (T1), and external locus of control predicted 58% of the variation of PTSD. Conclusions: High levels of PTSD symptoms occurred in 19.2% of respondents in six months following traumatic injury requiring ICU admission. Screening for the variables gender, length of sedation, dissociation, hypervigilance, and locus of control after ICU admission following traumatic injuries may help to predict who will develop PTSD.
doi:10.1080/21642850.2014.943760
PMCID: PMC4346029  PMID: 25750824
posttraumatic stress; intensive care; trauma; ICU survivors

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