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1.  Manipulation under sedation in the accident and emergency department. 
The Royal College of Surgeons of England recently published guidelines for sedation by non-anaesthetists. The report emphasizes sedation for endoscopy and dental surgery, but the recommendations are equally relevant to accident and emergency (A&E) medicine. Current sedation practice for orthopaedic manipulations was determined by questionnaire in 58 A&E and orthopaedic junior staff in one teaching and one district general hospital. Of the 50 doctors who completed the questionnaire, 14 (28%) respondents made an inadequate pre-sedation assessment. Over half were unable to name the antagonist to benzodiazepine drugs. Eleven (22%) doctors administered supplemental oxygen to all their patients, 12 (24%) did not consider it necessary. Pulse oximetry was used for patient monitoring by one respondent (2%). None of the junior staff had received any formal training in sedation techniques. Thirty-one (62%) had attended a resuscitation refresher course within the last year. These results emphasize the need for training in sedation techniques for A&E and orthopaedic juniors and the importance of appropriate supervision.
PMCID: PMC1342429  PMID: 7804587
2.  The ANKLe Score: An Audit of Otolaryngology Emergency Clinic Record Keeping 
Accurate and legible medical records are essential to good quality patient care. Guidelines from The Royal College of Surgeons of England (RCSE) state the content required to form a complete medical record, but do not address legibility. An audit of otolaryngology emergency clinic record keeping was performed using a new scoring system.
The Adjusted Note Keeping and Legibility (ANKLe) score was developed as an objective and quantitative method to assess both the content and legibility of case notes, incorporating the RCSE guidelines. Twenty consecutive otolaryngology emergency clinic case notes from each of 7 senior house officers were audited against standards for legibility and content using the ANKLe score. A proforma was introduced to improve documentation and handwriting advice was given. A further set of 140 notes (20 notes for each of the 7 doctors) was audited in the same way to provide feedback.
The introduction of a proforma and advice on handwriting significantly increased the quality of case note entries in terms of content, legibility and overall ANKLe score.
Accurate note keeping can be improved by the use of a proforma. The legibility of handwriting can be improved using simple advice. The ANKLe score is an objective assessment tool of the overall quality of medical note documentation which can be adapted for use in other specialties.
PMCID: PMC2430432  PMID: 18430339
Medical audit; Medical records; Handwriting; Quality
3.  Usefulness of applying lidocaine in esophagogastroduodenoscopy performed under sedation with propofol 
AIM: To determine whether topical lidocaine benefits esophagogastroduoduenoscopy (EGD) by decreasing propofol dose necessary for sedation or procedure-related complications.
METHODS: The study was designed as a prospective, single centre, double blind, randomised clinical trial and was conducted in 2012 between January and May (NCT01489891). Consecutive patients undergoing EGD were randomly assigned to receive supplemental topical lidocaine (L; 50 mg in an excipient solution which was applied as a spray to the oropharynx) or placebo (P; taste excipients solution without active substance, similarly delivered) prior to the standard propofol sedation procedure. The propofol was administered as a bolus intravenous (iv) dose, with patients in the L and P groups receiving initial doses based on the patient’s American Society of Anaesthesiologists (ASA) classification (ASA I-II: 0.50-0.60 mg/kg; ASA III-IV: 0.25-0.35 mg/kg), followed by 10-20 mg iv dose every 30-60 s at the anaesthetist’s discretion. Vital signs, anthropometric measurements, amount of propofol administered, sedation level reached, examination time, and the subjective assessments of the endoscopist’s and anaesthetist’s satisfaction (based upon a four point Likert scale) were recorded. All statistical tests were performed by the Stata statistical software suite (Release 11, 2009; StataCorp, LP, College Station, TX, United States).
RESULTS: No significant differences were found between the groups treated with lidocaine or placebo in terms of total propofol dose (310.7 ± 139.2 mg/kg per minute vs 280.1 ± 87.7 mg/kg per minute, P = 0.15) or intraprocedural propofol dose (135.3 ± 151.7 mg/kg per minute vs 122.7 ± 96.5 mg/kg per minute, P = 0.58). Only when the L and P groups were analysed with the particular subgroups of female, < 65-year-old, and lower anaesthetic risk level (ASA I-II) was a statistically significant difference found (L: 336.5 ± 141.2 mg/kg per minute vs P: 284.6 ± 91.2 mg/kg per minute, P = 0.03) for greater total propofol requirements). The total incidence of complications was also similar between the two groups, with the L group showing a complication rate of 32.2% (95%CI: 21.6-45.0) and the P group showing a complication rate of 26.7% (95%CI: 17.0-39.0). In addition, the use of lidocaine had no effect on the anaesthetist’s or endoscopist’s satisfaction with the procedure. Thus, the endoscopist’s satisfaction Likert assessments were equally distributed among the L and P groups: unsatisfactory, [L: 6.8% (95%CI: 2.2-15.5) vs P: 0% (95%CI: 0-4.8); neutral, L: 10.1% (95%CI: 4.2-19.9) vs P: 15% (95%CI: 7.6-25.7)]; satisfactory, [L: 25.4% (95%CI: 10-29.6) vs P: 18.3% (95%CI: 15.5-37.6); and very satisfactory, L: 57.6% (95%CI: 54-77.7) vs P: 66.6% (95%CI: 44.8-69.7)]. Likewise, the anaesthetist’s satisfaction Likert assessments regarding the ease of maintaining a patient at an optimum sedation level without agitation or modification of the projected sedation protocol were not affected by the application of lidocaine, as evidenced by the lack of significant differences between the scores for the placebo group: unsatisfactory, L: 5.8% (95%CI: 1.3-13.2) vs P: 0% (95%CI: 0-4.8); neutral, L: 16.9% (95%CI: 8.9-28.4) vs P: 16.7% (95%CI: 8.8-27.7); satisfactory, L: 15.2% (95%CI: 7.7-26.1) vs P: 20.3% (95%CI: 11.3-31.6); and very satisfactory, L: 62.7% (95%CI: 49.9-74.3) vs P: 63.3% (95%CI: 50.6-74.7).
CONCLUSION: Topical pharyngeal anaesthesia is safe in EGD but does not reduce the necessary dose of propofol or improve the anaesthetist’s or endoscopist’s satisfaction with the procedure.
PMCID: PMC3653022  PMID: 23678376
Lidocaine; Propofol; Esophagogastroduodenoscopy; Sedation; Adverse effects
4.  Evaluation of a Minimally Invasive Cell Sampling Device Coupled with Assessment of Trefoil Factor 3 Expression for Diagnosing Barrett's Esophagus: A Multi-Center Case–Control Study 
PLoS Medicine  2015;12(1):e1001780.
Barrett's esophagus (BE) is a commonly undiagnosed condition that predisposes to esophageal adenocarcinoma. Routine endoscopic screening for BE is not recommended because of the burden this would impose on the health care system. The objective of this study was to determine whether a novel approach using a minimally invasive cell sampling device, the Cytosponge, coupled with immunohistochemical staining for the biomarker Trefoil Factor 3 (TFF3), could be used to identify patients who warrant endoscopy to diagnose BE.
Methods and Findings
A case–control study was performed across 11 UK hospitals between July 2011 and December 2013. In total, 1,110 individuals comprising 463 controls with dyspepsia and reflux symptoms and 647 BE cases swallowed a Cytosponge prior to endoscopy. The primary outcome measures were to evaluate the safety, acceptability, and accuracy of the Cytosponge-TFF3 test compared with endoscopy and biopsy.
In all, 1,042 (93.9%) patients successfully swallowed the Cytosponge, and no serious adverse events were attributed to the device. The Cytosponge was rated favorably, using a visual analogue scale, compared with endoscopy (p < 0.001), and patients who were not sedated for endoscopy were more likely to rate the Cytosponge higher than endoscopy (Mann-Whitney test, p < 0.001). The overall sensitivity of the test was 79.9% (95% CI 76.4%–83.0%), increasing to 87.2% (95% CI 83.0%–90.6%) for patients with ≥3 cm of circumferential BE, known to confer a higher cancer risk. The sensitivity increased to 89.7% (95% CI 82.3%–94.8%) in 107 patients who swallowed the device twice during the study course. There was no loss of sensitivity in patients with dysplasia. The specificity for diagnosing BE was 92.4% (95% CI 89.5%–94.7%). The case–control design of the study means that the results are not generalizable to a primary care population. Another limitation is that the acceptability data were limited to a single measure.
The Cytosponge-TFF3 test is safe and acceptable, and has accuracy comparable to other screening tests. This test may be a simple and inexpensive approach to identify patients with reflux symptoms who warrant endoscopy to diagnose BE.
Editors' Summary
Barrett's esophagus is a condition in which the cells lining the esophagus (the tube that transports food from the mouth to the stomach) change and begin to resemble the cells lining the intestines. Although some people with Barrett's esophagus complain of burning indigestion or acid reflux from the stomach into the esophagus, many people have no symptoms or do not seek medical advice, so the condition often remains undiagnosed. Long-term acid reflux (gastroesophageal reflux disease), obesity, and being male are all risk factors for Barrett's esophagus, but the condition's exact cause is unclear. Importantly, people with Barrett's esophagus are more likely to develop esophageal cancer than people with a normal esophagus, especially if a long length (segment) of the esophagus is affected or if the esophagus contains abnormally growing “dysplastic” cells. Although esophageal cancer is rare in the general population, 1%–5% of people with Barrett's esophagus develop this type of cancer; about half of people diagnosed with esophageal cancer die within a year of diagnosis.
Why Was This Study Done?
Early detection and treatment of esophageal cancer increases an affected individual's chances of survival. Thus, experts recommend that people with multiple risk factors for Barrett's esophagus undergo endoscopic screening—a procedure that uses a small camera attached to a long flexible tube to look for esophageal abnormalities. Once diagnosed, patients with Barrett's esophagus generally enter an endoscopic surveillance program so that dysplastic cells can be identified as soon as they appear and removed using endoscopic surgery or “radiofrequency ablation” to prevent cancer development. However, although endoscopic screening of everyone with reflux symptoms for Barrett's esophagus could potentially reduce deaths from esophageal cancer, such screening is not affordable for most health care systems. In this case–control study, the researchers investigate whether a cell sampling device called the Cytosponge coupled with immunohistochemical staining for Trefoil Factor 3 (TFF3, a biomarker of Barrett's esophagus) can be used to identify individuals who warrant endoscopic investigation. A case–control study compares the characteristics of patients with and without a specific disease. The Cytosponge is a small capsule-encased sponge that is attached to a string. The capsule rapidly dissolves in the stomach after being swallowed, and the sponge collects esophageal cells for TFF3 staining when it is retrieved by pulling on the string.
What Did the Researchers Do and Find?
The researchers enrolled 463 individuals attending 11 UK hospitals for investigational endoscopy for dyspepsia and reflux symptoms as controls, and 647 patients with Barrett's esophagus who were attending hospital for monitoring endoscopy. Before undergoing endoscopy, the study participants swallowed a Cytosponge so that the researchers could evaluate the safety, acceptability, and accuracy of the Cytosponge-TFF3 test for the diagnosis of Barrett's esophagus compared with endoscopy. Nearly 94% of the participants swallowed the Cytosponge successfully, there were no adverse effects attributed to the device, and those participants that swallowed the device generally rated the experience as acceptable. The overall sensitivity of the Cytosponge-TFF3 test (its ability to detect true positives) was 79.9%. That is, 79.9% of the individuals with endoscopically diagnosed Barrett's esophagus were identified as having the condition using the new test. The sensitivity of the test was greater among patients who had a longer length of affected esophagus and importantly was not reduced in patients with dysplasia. Compared to endoscopy, the specificity of the Cytosponge-TFF3 test (its ability to detect true negatives) was 92.4%. That is, 92.4% of people unaffected by Barrett's esophagus were correctly identified as being unaffected.
What Do These Findings Mean?
The case–control design of this study means that its results are not generalizable to a primary care population. Also, the study used only a single measure of the acceptability of the Cytosponge-TFF3 test, Nevertheless, these findings indicate that this minimally invasive test for Barrett's esophagus is safe and acceptable, and that its accuracy is similar to that of colorectal cancer and cervical cancer screening tests. The Cytosponge-TFF3 test might, therefore, provide a simple, inexpensive way to identify those patients with reflux symptoms who warrant endoscopy to diagnose Barrett's esophagus, although randomized controlled trials of the test are needed before its routine clinical implementation. Moreover, because most people with Barrett's esophagus never develop esophageal cancer, additional biomarkers ideally need to be added to the test before its routine implementation to identify those individuals who have the greatest risk of esophageal cancer, and thereby avoid overtreatment of Barrett's esophagus.
Additional Information
Please access these websites via the online version of this summary at
The US National Institute of Diabetes and Digestive and Kidney Diseases provides detailed information about Barrett's esophagus and gastroesophageal reflux disease
The US National Cancer Institute provides information for patients and health professionals about esophageal cancer (in English and Spanish)
Cancer Research UK (a non-profit organization) provides detailed information about Barrett's esophagus (including a video about having the Cytosponge test and further information about this study, the BEST2 Study) and about esophageal cancer
The UK National Health Service Choices website has pages on the complications of gastroesophageal reflux and on esophageal cancer (including a real story)
Heartburn Cancer Awareness Support is a non-profit organization that aims to improve public awareness and provides support for people affected by Barrett's esophagus; the organization's website explains the range of initiatives to promote education and awareness as well as highlighting personal stories of those affected by Barrett's esophagus and esophageal cancer
The British Society of Gastroenterology has published guidelines on the diagnosis and management of Barrett's esophagus
The UK National Institute for Health and Care Excellence has published guidelines for gastroesophageal reflux
The Barrett's Esophagus Campaign is a UK-based non-profit organization that supports research into the condition and provides support for people affected by Barrett's esophagus; its website includes personal stories about the condition
In a multi-center case-control study, Rebecca Fitzgerald and colleagues examine whether a minimally invasive cell sampling device could be used to identify patients who warrant endoscopy to diagnose Barrett's esophagus.
PMCID: PMC4310596  PMID: 25634542
5.  Feasibility of breath monitoring in patients undergoing elective colonoscopy under propofol sedation: A single-center pilot study 
AIM: To determine whether a newly developed respiratory rate monitor can practically and accurately monitor ventilation under propofol sedation in combination with standard monitoring.
METHODS: Patients [American Society of Anesthesiologists (ASA) Classification I-III] scheduled for elective colonoscopy under propofol sedation were monitored with a new device that measures the respiratory rate based on humidity in expired air. Patients with clinically significant cardiac disorders or pulmonary disease and patients requiring emergency procedures were excluded from study participation. All of the patients also received standard monitoring with pulse oximetry. This was a single-center study conducted in a community hospital in Switzerland. After obtaining written informed consent from all subjects, 76 patients (51 females and 25 males) were monitored during colonoscopy under propofol sedation. The primary endpoint was the occurrence of any respiratory event (apnea or hypopnea). Apnea was defined as the cessation of breathing for a minimum of 10 s. Significant apnea was defined as the cessation of breathing for more than 30 s. Hypopnea was defined as a reduction in the respiratory rate below 6/min for a minimum of 10 s. Any cases of significant apnea triggered interventions by the endoscopy team. The interventions included withholding propofol, verbal stimulation of the patients, and increased oxygen supplementation or the chin lift maneuver. A secondary endpoint was the correlation of apnea or hypopnea with hypoxemia (measured as a decrease in SaO2 of at least 5% from baseline or less than 90%).
RESULTS: At least one respiratory event was detected in thirty-seven patients (48.7%). In total, there were 73 respiratory events, ranging from one to six events in a single patient. Significant apnea (> 30 s) occurred in five patients (6%). Only one episode of apnea led to a relative SaO2 reduction (from 98% to 93%) after a 50 s lag time. No event requiring assisted ventilation was recorded. Our analysis revealed that the total propofol dose was an independent risk factor for respiratory events (P = 0.01). Artifacts developed with the same frequency with the new device as with conventional pulse oximetry. Compared with pulse oximetry alone, this new monitoring device detected more respiratory events and may provide earlier warning of impending respiratory abnormalities.
CONCLUSION: Apnea commonly occurs during endoscopy under sedation and may precede hypoxemia. We recommend this respiration rate monitor as an alternative to capnography to aid in detecting ventilatory problems.
PMCID: PMC3952164  PMID: 24634712
Apnea; Colonoscopy; Conscious sedation; Deep sedation; Propofol; Pulse oximetry; Respiratory monitoring
6.  An audit of corneal abrasion management following the introduction of local guidelines in an accident and emergency department 
Emergency Medicine Journal : EMJ  2006;23(7):526-529.
Background and objectives
Corneal abrasions are a common presentation to accident and emergency (A&E) departments. Patients can be treated and discharged by A&E staff without the need for an ophthalmologist's attention; complicated cases, however, should be recognised and referred. Inexperience and limited training in ophthalmology may lead to suboptimal patient care and inappropriate use of ophthalmology outpatient clinics. Issues of poor documentation may also arise. The purpose of this audit was to assess the effect of guidelines on the management of corneal abrasion by A&E staff.
A retrospective case note audit was performed to assess current management of corneal abrasions. Guidelines for management of corneal abrasions were formulated following a literature search and collaboration between A&E and ophthalmology staff. A prospective case note audit was undertaken to assess management after introduction of the guidelines.
A total of 51 cases were audited before the introduction of the guidelines and 57 cases after. Following the introduction of the guidelines documentation of visual acuity increased to 93% and specific enquiry into contact lens wear rose from 35.3% to 71.9%. A&E staff stopped giving out local anaesthetic eye drops. The follow up profile also improved; appropriate patient discharges increased by 40% whereas inappropriate referrals to eye clinic dropped by 75%. More patients were given abrasion advice (a 101% increase).
A&E staff members are capable of managing corneal abrasions if they are given guidance and some training. This audit identified shortcomings in current management and showed that guidelines can significantly improve clinical practice.
PMCID: PMC2579545  PMID: 16794094
corneal; abrasion; guidelines; A&E
7.  Respiratory effects of dexmedetomidine in the surgical patient requiring intensive care 
Critical Care  2000;4(5):302-308.
The respiratory effects of dexmedetomidine were retrospectively examined in 33 postsurgical patients involved in a randomised, placebo-controlled trial after extubation in the intensive care unit (ICU). Morphine requirements were reduced by over 50% in patients receiving dexmedetomidine. There were no differences in respiratory rates, oxygen saturations, arterial pH and arterial partial carbon dioxide tension (PaCO2) between the groups. Interestingly the arterial partial oxygen tension (PaO2) : fractional inspired oxygen (FIO2) ratios were statistically significantly higher in the dexmedetomidine group. Dexmedetomidine provides important postsurgical analgesia and appears to have no clinically important adverse effects on respiration in the surgical patient who requires intensive care.
The α2-agonist dexmedetomidine is a new class of sedative drug that is being investigated for use in ICU settings. It is an effective agent for the management of sedation and analgesia after cardiac, general, orthopaedic, head and neck, oncological and vascular surgery in the ICU [1]. Cardiovascular stability was demonstrated, with significant reductions in rate-pressure product during sedation and over the extubation period.
Dexmedetomidine possesses several properties that may additionally benefit those critically ill patients who require sedation. In spontaneously breathing volunteers, intravenous dexmedetomidine caused marked sedation with only mild reductions in resting ventilation at higher doses [2]. Dexmedetomidine reduces the haemodynamic response to intubation and extubation [3,4,5] and attenuates the stress response to surgery [6], as a result of the α2-mediated reduction in sympathetic tone. Therefore, it should be possible to continue sedation with dexmedetomidine over the stressful extubation period without concerns over respiratory depression, while ensuring that haemodynamic stability is preserved.
The present study is a retrospective analysis of the respiratory response to dexmedetomidine in 33 postsurgical patients (who were involved in a randomized, double-blind, placebo-controlled trial [1]) after extubation in the ICU.
Patients who participated in the present study were admitted after surgery to our general or cardiothoracic ICUs, and were expected to receive at least 6 h of postsurgical sedation and artificial ventilation.
On arrival in the ICU after surgery, patients were randomized to receive either dexmedetomidine or placebo (normal saline) with rescue sedation and analgesia being provided, only if clinically needed, with midazolam and morphine boluses, respectively. Sedation was titrated to maintain a Ramsay Sedation Score [7] of 3 or greater while the patients were intubated, and infusions of study drug were continued for a maximum of 6 h after extubation to achieve a Ramsay Sedation Score of 2 or greater.
The patients were intubated and ventilated with oxygen-enriched air to attain acceptable arterial blood gases, and extubation occurred when clinically indicated. All patients received supplemental oxygen after extubation, which was delivered by a fixed performance device. Assessment of pain was by direct communication with the patient.
Results are expressed as mean ± standard deviation unless otherwise stated. Patient characteristics, operative details and morphine usage were analyzed using the Mann-Whitney U-test. Statistical differences for respiratory measurements between the two groups were determined using analysis of variance for repeated measures, with the Bonferroni test for post hoc comparisons.
Of the 40 patients who participated in the study, seven patients could not be included in the analysis of respiratory function because they did not receive a study drug infusion after extubation. Consequently, data from 33 patients are used in the analysis of respiratory function; 16 received dexmedetomidine and 17 placebo. Inadequate arterial blood gas analysis was available in five patients (two from the dexmedetomidine group, and three from the placebo group). There were no significant differences in patient characteristics and operative details between the groups.
Requirements for morphine were reduced by more than 50% in patients receiving dexmedetomidine when compared with placebo after extubation (0.003 ± 0.004 vs 0.008 ± 0.006 mg/kg per h; P= 0.040).
There were no statistically significant differences between placebo and dexmedetomidine for oxygen saturations measured by pulse oximetry (P= 0.26), respiratory rate (P= 0.16; Fig. 1), arterial pH (P= 0.77) and PaCO2 (P= 0.75; Fig. 2) for the 6 h after extubation.
The dexmedetomidine group showed significantly higher PaO2: FIO2 ratios throughout the 6-h intubation (P= 0.036) and extubation (P= 0.037) periods (Fig. 3). There were no adverse respiratory events seen in either the dexmedetomidine or placebo group.
Respiratory rate for the 6-h periods before and after extubation. (Filled circle) Dexmedetomidine; (Empty circle) placebo. Values are expressed as mean ± standard deviation.
PaCO2 (PCO2) for the 6-h periods before and after extubation, and baseline values (B) on admission to ICU immediately after surgery. (Filled circle) Dexmedetomidine; (Empty circle) placebo. Values are expressed as mean ± standard deviation.
PaO2 : FIO2 ratio for the 6-h periods before and after extubation, and baseline values (B) on admission to ICU immediately after surgery. (Filled circle) Dexmedetomidine; (Empty circle) placebo. Values are expressed as mean ± standard deviation.
Lack of respiratory depression in patients sedated with α2-adrenoceptor agonists was first reported by Maxwell [8] in a study investigating the respiratory effects of clonidine. However, more recent data suggests that clonidine may cause mild respiratory depression in humans [9], and α2-adrenoceptor agonists are well known to produce profound intraoperative hypoxaemia in sheep [10,11]. The effects of dexmedetomidine on other ventilation parameters also appear to be species specific [12].
Belleville et al [2] investigated the ventilatory effects of a 2-min intravenous infusion of dexmedetomidine on human volunteers. According to those investigators, minute ventilation and arterial PaCO2 were mildly decreased and increased, respectively. There was a rightward shift and depression of the hypercapnic response with infusions of 1.0 and 2.0 μg/kg.
Previous studies that investigated the respiratory effects of dexmedetomidine have only been performed in healthy human volunteers, who have received either single intramuscular injections or short (= 10 min) intravenous infusions of dexmedetomidine. It is therefore reassuring that no deleterious clinical effects on respiration and gas exchange were seen in the patients we studied, who were receiving long-term infusions. However, there are important limitations to the present results. No dose/response curve for dexmedetomidine can be formulated from the data, and further investigation is probably ethically difficult to achieve in the spontaneously ventilating intensive care patient. We also have no data on the ventilatory responses to hypercapnia and hypoxia, which would also be difficult to examine practically and ethically. The placebo group received more than twice as much morphine as patients receiving dexmedetomidine infusions after extubation, but there were no differences in respiratory rate or PaCO2 between the groups. We can not therefore determine from this study whether dexmedetomidine has any benefits over morphine from a respiratory perspective.
There were no differences in oxygen saturations between the groups because the administered oxygen concentration was adjusted to maintain satisfactory gas exchange. Interestingly, however, there were statistically significant higher PaO2 : FIO2 ratios in the dexmedetomidine group. This ratio allows for the variation in administered oxygen to patients during the study period, and gives some clinical indication of alveolar gas exchange. However, this variable was not a primary outcome variable for the present study, and may represent a type 1 error, although post hoc analysis reveals that the data have 80% power to detect a significant difference (α value 0.05). Further studies are obviously required.
Sedation continued over the extubation period, has been shown to reduce haemodynamic disturbances and myocardial ischaemia [13]. We have previously shown [1] that dexmedetomidine provides cardiovascular stability, with a reduction in rate-pressure product over the extubation period. A sedative agent that has analgesic properties, minimal effects on respiration and offers ischaemia protection would have enormous potential in the ICU. Dexmedetomidine may fulfill all of these roles, but at present we can only conclude that dexmedetomidine has no deleterious clinical effects on respiration when used in doses that are sufficient to provide adequate sedation and effective analgesia in the surgical population requiring intensive care.
PMCID: PMC29047  PMID: 11056756
α2-Adrenoceptor agonist; analgesia; dexmedetomidine; intensive care; postoperative; respiratory; sedation
8.  Effect of a preprinted form on the management of acute asthma in an accident and emergency department. 
OBJECTIVE--To assess the effect of a preprinted form on the documentation of clinical data and compliance with the national guidelines for the management of asthma. METHODS--Prospective audit six months before and after introduction of the form. RESULTS--Use of the form improved the documentation of past asthma history (69% v 93%, P < 0.001), current treatment (81% v 95%, P < 0.01), predicted peak flow (23% v 75%, P < 0.001), per cent predicted peak flow (1% v 62%, P < 0.001), and respiratory rate (81% v 95%, P = 0.007). Compliance with the British recommendations for treatment improved with use of the form (50% v 89%, P < 0.001) The prescription of steroids on discharge did not improve significantly (26% v 44%, P > 0.05). CONCLUSIONS--The preprinted form resulted in enhanced documentation of data and conformity with current guidelines for the management of asthma.
PMCID: PMC1342645  PMID: 8653258
9.  Safety and effectiveness of intranasal administration of sedative medications (ketamine, midazolam, or sufentanil) for urgent brief pediatric dental procedures. 
Anesthesia Progress  1993;40(3):63-66.
Thirty children presenting to the dental clinic of a pediatric hospital who required brief but urgent dental care, and who could not be satisfactorily examined or treated, were administered one of three medications--ketamine (Ketalar), 3 mg/kg; midazolam (Versed), 0.4 mg/kg; or sufentanil (Sufenta), 1.5 or 1.0 micrograms/kg--intranasally in a randomized, double-blinded protocol. The patients were brought to the day surgery area following appropriate fasting and administered one of the medications diluted in a dose of 0.1 mL/kg normal saline while sitting in a nurse's arms. Cardiorespiratory monitors were applied when tolerated, and the child was placed on the operating room table. Each child was injected locally with up to one dental cartridge of 2% lidocaine with 1:100,000 epinephrine before dental extractions. A sedation score was recorded using a scale where 1 = hysterical/untreatable, 5 = ideal sedation, and 10 = obtunded and desaturated, requiring airway management assistance. Midazolam administration resulted in acceptable sedation (mean score: 4) with no desaturations below 90% as measured by pulse oximetry and a mean recovery room observation time of only 3 +/- 2 min (+/- SD). Ketamine also had a mean sedation score of 4 and a short recovery period (7 +/- 7 min); however, two children experienced brief desaturations. Sufentanil at 1.5 micrograms/kg was noted to produce much more heavily sedated children (mean score 7), with a high incidence of significant oximetry desaturation (80%) and prolonged recovery room duration (58 +/- 40 min). Use of 1.0 microgram/kg sufentanil resulted in no desaturations, less sedation (mean score 4), and a brief recovery time (7 +/- 13 min).(ABSTRACT TRUNCATED AT 250 WORDS)
PMCID: PMC2148744  PMID: 7645790
10.  An Objective Evaluation of Clinical Signs Used to Assess Sedation with Intravenous Diazepam 
Anesthesia Progress  1980;27(1):18-20.
In the majority of dental schools there are insufficient numbers of clinical patients for all students to receive optimal experience in intravenous sedation. This investigation was carried out to assess whether the signs and symptoms for intravenous sedation taught to the undergraduates were sufficiently objective to ensure that this clinical deficiency was not detrimental to competency of the graduating student. The signs of ptosis, altered speech and blurred vision were used by both experienced dentists and novice students to assess the level of intravenous sedation. Blurred vision was found to be unreliable while altered speech was more accurate than ptosis. The more experienced the operator the earlier the signs were observed.
The “Guidelines for the Teaching of Pain and Anxiety Control in Dentistry” were initially formulated by the American Dental Association in 1971 and revised in 19781 while similar guidelines were accepted by the House of Delegates of the Association of the Canadian Faculties of Dentistry in 19752 Both of these documents outlined the course of instructions necessary for the teaching of all modalities of pain and apprehension control at the undergraduate, postgraduate and continuing education level. Implementation of these guidelines at the undergraduate level has proven to be particularly difficult in the area of intravenous sedation because of the lack of suitable patients. This has resulted in many students graduating, having had little practical experience in sedating a patient with an intravenous drug. It is the hope of educators in this field that lectures, seminars, and demonstrations given to dental students are sufficient to overcome this deficiency.
Since the most critical clinical aspect of intravenous sedation is titrating the amount of drug required without overdosing or underdosing the patient, it was decided to investigate this ability in students with no clinical experience with intravenous diazepam. Although many drugs and techniques are advocated3,4,5 it was decided to limit the study to intravenous diazepam as it may be used alone and has a high therapeutic index.
With the introduction of diazepam to clinical practice the symptomatology of the drug was established and described by clinicians.6,7 Objective methods of measuring recovery from diazepam have been described by several authors8,9,10 but the signs and symptoms used to assess the initial level of sedation have been subjective. This can be attributed to the fact that sedation is an ill-defined clinical effect and can, therefore, only be calibrated by individual arbitary signs. The most frequently used signs for intravenous diazepam sedation are ptosis, also referred to as “the Verrill sign,”11 altered speech and blurred vision.7 This investigation was designed to test the reliability of these signs and to examine the variability of observations between clinicians and students.
PMCID: PMC2515966  PMID: 6933870
11.  Evaluation of a minimal sedation protocol using ICU sedative consumption as a monitoring tool: a quality improvement multicenter project 
Critical Care  2014;18(5):580.
Oversedation frequently occurs in ICUs. We aimed to evaluate a minimal sedation policy, using sedative consumption as a monitoring tool, in a network of ICUs targeting decrement of oversedation and mechanical ventilation (MV) duration.
A prospective quality improvement project was conducted in ten ICUs within a network of nonteaching hospitals in Brazil during a 2-year period (2010 to 2012). In the first 12 months (the preintervention period), we conducted an audit to identify sedation practice and barriers to current guideline-based practice regarding sedation. In the postintervention period, we implemented a multifaceted program, including multidisciplinary daily rounds, and monthly audits focusing on sedative consumption, feedback and benchmarking purposes. To analyze the effect of the campaign, we fit an interrupted time series (ITS). To account for variability among the network ICUs, we fit a hierarchical model.
During the study period, 21% of patients received MV (4,851/22,963). In the postintervention period, the length of MV was lower (3.91 ± 6.2 days versus 3.15 ± 4.6 days; mean difference, −0.76 (95% CI, −1.10; −0.43), P <0.001) and 28 ventilator-free days were higher (16.07 ± 12.2 days versus 18.33 ± 11.6 days; mean difference, 2.30 (95% CI, 1.57; 3.00), P <0.001) than in the preintervention period. Midazolam consumption (in milligrams per day of MV) decreased from 329 ± 70 mg/day to 163 ± 115 mg/day (mean difference, −167 (95% CI, −246; −87), P <0.001). In contrast, consumption of propofol (P = 0.007), dexmedetomidine (P = 0.017) and haloperidol (P = 0.002) increased in the postintervention period, without changes in the consumption of fentanyl. Through ITS, age (P = 0.574) and Simplified Acute Physiology Score III (P = 0.176) remained stable. The length of MV showed a secular effect (secular trend β1 = −0.055, P = 0.012) and a strong decrease immediately after the intervention (intervention β2 = −0.976, P <0.001). The impact was maintained over the course of one year, despite the waning trend for the intervention’s effect (postintervention trend β3 = 0.039, P = 0.095).
By using a light sedation policy in a group of nonteaching hospitals, we reproduced the benefits that have previously been demonstrated in controlled settings. Furthermore, systematic monitoring of sedative consumption should be a feasible instrument for supporting the implementation of a protocol on a large scale.
Electronic supplementary material
The online version of this article (doi:10.1186/s13054-014-0580-3) contains supplementary material, which is available to authorized users.
PMCID: PMC4234844
12.  Sedation in Adults Receiving Mechanical Ventilation: Physiological and Comfort Outcomes 
To describe the relationships among sedation, stability in physiological status, and comfort during a 24-hour period in patients receiving mechanical ventilation.
Data from 169 patients monitored continuously for 24 hours were recorded at least every 12 seconds, including sedation levels, physiological status (heart rate, respiratory rate, oxygen saturation by pulse oximetry), and comfort (movement of arms and legs as measured by actigraphy). Generalized linear mixed-effect models were used to estimate the distribution of time spent at various heart and respiratory rates and oxygen saturation and actigraphy intervals overall and as a function of level of sedation and to compare the percentage of time in these intervals between the sedation states.
Patients were from various intensive care units: medical respiratory (52%), surgical trauma (35%), and cardiac surgery (13%). They spent 42% of the time in deep sedation, 38% in mild/moderate sedation, and 20% awake/alert. Distributions of physiological measures did not differ during levels of sedation (deep, mild/moderate, or awake/alert: heart rate, P = .44; respirations, P = .32; oxygen saturation, P = .51). Actigraphy findings differed with level of sedation (arm, P < .001; leg, P = .01), with less movement associated with greater levels of sedation, even though patients spent the vast majority of time with no arm movement or leg movement.
Level of sedation most likely does not affect the stability of physiological status but does have an effect on comfort.
PMCID: PMC3703630  PMID: 22549581
13.  Sedation practice in the intensive care unit: a UK national survey 
Critical Care  2008;12(6):R152.
The purpose of this study was to evaluate sedation practice in UK intensive care units (ICUs), particularly the implementation of daily sedation holding, written sedation guidelines, sedation scoring tools and choice of agents.
A national postal survey was conducted in all UK ICUs.
A total of 192 responses out of 302 addressed units were received (63.5%). Of the responding ICUs, 88% used a sedation scoring tool, most frequently the Ramsey Sedation Scale score (66.4%). The majority of units have a written sedation guideline (80%), and 78% state that daily sedation holding is practiced. A wide variety of sedating agents is used, with the choice of agent largely determined by the duration of action rather than cost. The most frequently used agents were propofol and alfentanil for short-term sedation; propofol, midazolam and morphine for longer sedation; and propofol for weaning purposes.
Most UK ICUs use a sedation guideline and sedation scoring tool. The concept of sedation holding has been implemented in the majority of units, and most ICUs have a written sedation guideline.
PMCID: PMC2646317  PMID: 19046459
14.  Frontal EEG for intensive care unit sedation: treating numbers or patients? 
Critical Care  2008;12(5):186.
In this issue of Critical Care, Dr Haenggi and co-workers present a study evaluating bispectral index (BIS), state entropy (SE) and response entropy in 44 patients sedated in the intensive care unit (ICU). As in recent studies attempting to correlate frontal electroencephalogram (EEG) measurements with clinical evaluations of sedative efficacy, there is considerable overlap in numerical EEG values and different clinical levels of sedation. This precludes the use of these monitors for monitoring or titrating sedation in the critically ill. Despite many attempts, no study has yet presented data showing improved outcome with the use of EEG monitors in ICU sedation. Meanwhile, clinical sedation protocols have emerged, improving important endpoints in critically ill patients needing sedation. A major underlying problem in applying EEG monitors in the ICU is that they have been developed for measuring anesthetic depth and the related risk of recall, rather than the acknowledged endpoints of sedation, namely reduction of anxiety and discomfort. Until an 'objective' monitor is developed to measure the degree of such symptoms, physicians should continue treating patients and not numbers.
PMCID: PMC2592758  PMID: 18983711
15.  Evaluation of a local ICU sedation guideline on goal-directed administration of sedatives and analgesics 
Journal of Pain Research  2011;4:127-134.
Sedatives and analgesics are commonly used in mechanically ventilated patients in the intensive care unit. Sedation guidelines have been shown to improve sedation management as well as various patient outcomes. The main objective was to evaluate adherence to a sedation guideline with both sedative prescribing and documentation of Richmond Agitation-Sedation Scale (RASS) scores.
In a retrospective chart review, data was collected on 111 medical intensive care unit patients mechanically ventilated via endotracheal tube for 12 hours or greater at Brigham and Women’s Hospital. Fifty-seven patients were evaluated pre-guideline implementation and 54 patients were evaluated post-guideline.
Significant increases were seen in the post-guideline group in goal-directed sedation with a patient-specific RASS goal in the sedation order: 21.3 vs 85.4% (P < 0.001), and mean number of sedation assessments per 24 hours using the RASS: 4.7 vs 11.4 (P < 0.001). Similarly, this group experienced a higher percentage of RASS scores at their sedation goal: 31.4 vs 44.1% (P < 0.001). No difference was seen in other clinical endpoints.
Implementation and routine application of a hospital pain and sedation guideline was associated with significantly improved sedation metrics, such as goal-directed sedation, as well as frequency of sedation level assessment and documentation. An increase was observed in the time that post-guideline patients spent at or near their RASS goal.
PMCID: PMC3100227  PMID: 21647216
sedation; agitation; guideline; RASS; mechanically ventilated; intensive care unit
16.  Epilepsy in the accident and emergency department--developing a code of safe practice for adult patients. South East and South West Thames Accident and Emergency Specialty Sub-committees. 
OBJECTIVES: To benchmark current practice in the management of adult patients presenting with seizures to the accident and emergency (A&E) departments by performing a comparative interdepartmental audit. To assess the quality and degree of completeness of documentation in A&E records and to develop a proforma for the documentation of any case presenting with a seizure which would incorporate management guidelines for use by A&E doctors. METHODS: This was a retrospective, criterion based audit carried out in 12 A&E departments in the South Thames region. It involved 1200 adult patients who presented to A&E departments after a seizure. The degree of completeness of A&E records was assessed using criteria identified by A&E consultants and neurologists. Guidelines for use in the management of patients with seizures have been produced. RESULTS: Important aspects of the history and examination were frequently unrecorded in patients' notes. The recording of vital signs was particularly poor. A diversity of practice was shown between the departments that were audited and the number of investigations performed in each department varied considerably. Hospital admissions for patients with first seizures varied widely between departments, ranging from between 34.6% to 91.7% of cases. Documentation of advice given to patients about driving was evident in just 0.9% of cases. CONCLUSIONS: Wide interdepartmental variation exists in both the quality of information recorded in A&E records and in the management of patients. Deficiencies could be minimised and potential improvements in the quality of documentation might be achieved by the introduction of a structured proforma incorporating pre-defined management guidelines.
PMCID: PMC1343134  PMID: 9681306
17.  Implementation of a High-Alert Medication Program 
The Permanente Journal  2008;12(2):15-22.
Introduction: Greater than 500,000 doses of high-alert medications are administered throughout the Kaiser Permanente Northern California (KPNC) Program on an annual basis. High-alert medications (HAM) carry a higher risk of harm than other medications and errors in the administration of HAM can have catastrophic clinical outcomes. The purpose of this project is to ensure safe medication practices and to eliminate medication errors that cause harm to our patients.
The Program: KPNC leadership, physicians, nurses, pharmacists, quality leaders, and labor unions worked with regional and local medication safety committees to: 1) standardize high-alert medication-handling practices; 2) enhance education programs related to medication practices, embedding these into annual core competencies of all staff who handle high-alert medications; 3) develop monitoring functions at both the regional and local levels to ensure sustainability and ongoing systems improvements. Begun in December 2005, this program covers the delivery of high-alert medications across the continuum of care and affects all patients receiving HAM.
Measures: The initial phase of the monitoring process was put in place to measure compliance with implementation. Over the first few months of the program the 90% minimal threshold was surpassed with regional overall compliance of 95%. Following this initial process, the Regional Medication Safety Committee developed monitoring tools. Department managers carry out these concurrent observational audits at the medical centers with oversight by the Assistant Administrators for Quality and Service. These audits are designed to measure whether or not all medications on the HAM list are handled specifically to policy requirements, eg, independent double-checks, HAM stickers, etc. Audit specifications are provided for each audit tool. Medical Center audit results from the third quarter of 2006 through the third quarter of 2007 have shown a regional aggregate of 97.7% compliance. As the high percentages of compliance have held constant over time, more actionable metrics are being put in place for 2008.
To determine whether or not the program is reducing HAM errors, data from the regional Quality and Risk database (MIDAS) related to all high-alert medication errors was reviewed. Two interventions were of note: in July of 2005, there was a renewed effort to educate leaders, managers, physicians, and staff on responsible reporting in a “just culture” and the introduction of the new Responsible Reporting Form. An increase in reporting was noted at this time. In December 2005, the HAM program was introduced. There is a statistically significant drop in errors reported for 23 consecutive months following this program. These findings were similar for all phases of the delivery process. A powerful indicator of improvement is the average days between major injury and death. As of November 30, 2007, it has been 232 days since the last significant negative event was reported due to a HAM.
Conclusion: This program has been implemented in all of the KPNC Medical Centers and is in the process of being implemented in all KP regions. This spread has been endorsed by the Medical Directors Quality Committee and by the KP Boards of Directors. The Interregional Medication Safety Committee is overseeing the spread process. A toolkit containing all of the required tools plus additional materials and information has been developed and made available throughout KP. The program is the recipient of the 2007 Lawrence Patient Safety Award.
PMCID: PMC3042285  PMID: 21364807
18.  Bispectral index versus COMFORT score to determine the level of sedation in paediatric intensive care unit patients: a prospective study 
Critical Care  2004;9(1):R9-R17.
Most clinicians give sedatives and analgesics according to their professional experience and the patient's estimated need for sedation. However, this approach is prone to error. Inadequate monitoring of sedation and analgesia may contribute to adverse outcomes and complications. With this in mind, data obtained continuously using nonstimulating methods such as bispectral index (BIS) may have benefits in comparison with clinical monitoring of sedation. The aim of this prospective observational trial was to evaluate the use of electroencephalographic (EEG) BIS for monitoring sedation in paediatric intensive care unit (PICU) patients.
Forty paediatric patients (<18 years) were sedated for mechanical ventilation in a cardiac surgical and general PICU. In each paediatric patient BIS and COMFORT score were obtained. The study protocol did not influence ongoing PICU therapy. BIS and corresponding COMFORT score were collected three times for each patient. Measurements with the best starting EEG impedances were analyzed further. Deep sedation was defined as a COMFORT score between 8 and 16, and light sedation as a score between 17 and 26. Biometric and physiological data, and Pediatric Risk of Mortality III scores were also recorded.
There was a good correlation (Spearman's rho 0.651; P = 0.001) between BIS and COMFORT score in the presence of deep sedation and low starting impedance. Receiver operating characteristic (ROC) analysis revealed best discrimination between deep and light sedation at a BIS level of 83.
In the presence of deep sedation, BIS correlated satisfactorily with COMFORT score results if low EEG impedances were guaranteed.
PMCID: PMC1065097  PMID: 15693968
bispectral index; electroencephalography; intensive care unit; paediatric; sedation
19.  What are hospitals doing about clinical guidelines? 
Quality in Health Care  1997;6(4):187-191.
OBJECTIVES: To assess the attitudes of senior hospital staff towards clinical guidelines, and to ascertain the perceived extent and benefits of their local use; to identify those hospitals with current or planned future written strategies for the systematic development of clinical guidelines, and the staff responsible for leading them; and to establish the essential elements of existing strategies, and the methods used to ensure the proper development, dissemination, implementation, and evaluation of local guidelines. DESIGN: Cross sectional survey. PARTICIPANTS: Senior staff of 270 acute hospitals in the United Kingdom (response rate 202/270 (75%)) in 1995. RESULTS: 197/199 (99%) of respondents thought that clinical guidelines were a good idea, and 176/196 (90%) were aware of some guideline activity occurring within their hospitals. The most important benefits of local guideline activity were increased healthcare efficiency and effectiveness, greater consistency of treatment, and team building. 174/194 (90%) of respondents were in favour of the development of a readily accessible national repository of evidence-based clinical guidelines. 38/201 (19%) of respondents had a clinical guidelines strategy and a further 91/201 (45%) said that they had plans to develop one in the near future. The need to improve clinical outcomes was most often reported as the reason for developing a strategy. Medical directors most commonly had formal responsibility to lead the strategy, but someone without formal responsibility ran the operation in half the hospitals. Only 18/36 (50%) of strategies gave advice on the development of guidelines; and only a few strategies made explicit statements on which clinical services to target for guideline development, or the methods to be used for their validation and promotion. Some strategies lacked explicit statements on methods to monitor adherence, routine review, and update of guidelines. Internal literature searches (29/31 (94%)), the use of national guidelines (29/32 (91%)), local consensus conferences (28/32 (88%)), and peer group review (21/24 (88%)) were the most popular methods of validation used in hospitals with a strategy. Methods used to promote the dissemination, implementation, and evaluation of clinical guidelines included clinical audit (31/32 (97%)), peer review (25/30 (83%)), continuing education (23/29 (79%)), targeting of opinion leaders (17/26 (65%)), use of structured case notes (14/31 (45%)), patient mediated interventions (9/26 (35%)), and patient specific reminders (8/26 (31%)). CONCLUSIONS: Most senior hospital staff have a favourable attitude towards clinical guidelines. Most hospitals are undertaking some guideline activity, but few seem to be doing so within a locally agreed hospital wide strategy in which guideline development, dissemination, implementation, and evaluation are systematically considered. Many of the current methods used to validate guidelines locally are inadequate. Evidence-based clinical guidelines should be developed nationally, leaving hospitals to focus their energies on the local adaptation, dissemination, implementation, and evaluation of such guidelines. Only in this way will local guidelines achieve their full potential to improve clinical care and patient outcomes.
PMCID: PMC1055490  PMID: 10177032
20.  A local perspective to asthma management in the accident and emergency department in Malta 
This study was performed to assess the management of adult patients presenting to the Mater Dei Hospital Accident and Emergency (A&E) department with acute asthma.
Subjects and Methods:
Asthmatic patients age 14 or older who presented to A&E department between January and October 2010 with asthma exacerbations were included. Data were collected from the clinical notes and analyzed.
A total of 244 patients (67.2% females) were included, 126 (51.6%) were admitted, 97 (39.8%) discharged and 21 (8.6%) discharged themselves against medical advice. There was a decline in the presentations between January and July, followed by an upward trend until October (P = 0.42). Pulse oximetry was performed in 207 patients (84.8%), arterial blood gases in 133 (54.5%), peak expiratory flow rate in 106 (43.4%) and chest radiography in 206 (84.4%) patients. The respiratory rate was documented in 151 (61.8%), heart rate in 204 (83.6%) and ability to complete sentences in 123 (50.4%) patients. One hundred and ninety six patients (80.3%) were given nebulized bronchodilators, 103 (42.2%) intravenous corticosteroids, 7 (2.87%) oral corticosteroids, 109 (44.7%) oxygen, 28 (11.5%) antibiotics and 9 (3.69%) magnesium. Systemic corticosteroids and antibiotics were more commonly prescribed to patients admitted (P < 0.001).
Management of acute asthma in Malta requires optimization in order to compare with international guidelines.
PMCID: PMC3841682  PMID: 24339483
Accident and emergency department; adults; asthma exacerbations
21.  Practice and documentation of palliative sedation: a quality improvement initiative 
Current Oncology  2014;21(2):100-103.
Palliative sedation (ps), the continuous use of sedating doses of medication to intentionally reduce consciousness and relieve refractory symptoms at end of life, is ethically acceptable if administered according to standards of best practice. Procedural guidelines outlining the appropriate use of ps and the need for rigorous documentation have been developed. As a quality improvement strategy, we audited the practice and documentation of ps on our palliative care unit (pcu).
A pharmacy database search of admissions in 2008 identified, for a subsequent chart review, patients who had received either a continuous infusion of midazolam (≥10 mg/24 h), regular parenteral dosing of methotrimeprazine (≥75 mg daily), or regular phenobarbital. Documentation of the decision-making process, consent, and medication use was collected using a data extraction form based on current international ps standards.
Interpretation and comparison of data were difficult because of an apparent lack of a consistent operational definition of ps. Patient records had no specific documentation in relation to ps initiation, to clearly identified refractory symptoms, and to informed consent in 60 (64.5%), 43 (46.2%), and 38 (40.9%) charts respectively. Variation in the medications used was marked: 54 patients (58%) were started on a single agent and 39 (42%), on multiple agents. The 40 patients (43%) started on midazolam alone received a mean daily dose of 21.4 mg (standard deviation: 24.6 mg).
The lack of documentation and standardized practice of ps on our pcu has resulted in a quality improvement program to address those gaps. They also highlight the importance of conducting research and developing clinical guidelines in this area.
PMCID: PMC3997441  PMID: 24764700
Palliative care; conscious sedation; deep sedation; documentation; hypnotics and sedatives
22.  Use of the CRABEL Score for improving surgical case-note quality. 
INTRODUCTION: Quality assurance of medical record keeping in general surgery is facilitated by use of the CRABEL Score. Critical appraisal and constant feedback to staff plays an important part in improving case-note quality. MATERIALS AND METHODS: For each case-note audit, a house officer reviewed two sets of case notes for each of six consultant surgeons. Scores were awarded according to initial clerking, subsequent entries, consent, and discharge summary. Overall scores were derived by subtracting deductions for omissions in each category from a starting score of 100. A larger number of points deducted due to absent data leads to a lower overall score and indicates poorer quality case notes. After four audits, a clerking proforma specifically designed to address some of the common areas of weakness identified in our record keeping was introduced and a further audit was performed in March 2004 to assess its impact. RESULTS: The mean score was lowest in the September 2001 audit and improved over the next two audits. However, there was a small reduction in September 2003 compared to September 2002. When the individual sections of the score were looked at separately, the greatest contribution to a poor score comes from the 'subsequent entries' section since there are five entries scored individually leading to a cumulative effect on the overall score. Within both the 'initial clerking' and 'subsequent entries' sections, early audits showed poor performance across a range of areas but consistent poor implementation of the guidelines was seen in a small number of specific areas as record keeping improved. The quality of medical notes improved over the first three cycles but the improvement was not maintained subsequently. DISCUSSION: The CRABEL score has been shown to be a useful, reproducible and easy-to-perform objective assessment of the quality of medical record keeping. Repeated audit cycles have ensured that case-note quality remains a high priority and have also led to the development of standardised admission documentation. Introduction of the latter has led to a measurable improvement in medical record keeping.
PMCID: PMC1964114  PMID: 16263017
23.  The incidence of sub-optimal sedation in the ICU: a systematic review 
Critical Care  2009;13(6):R204.
Patients in intensive care units (ICUs) are generally sedated for prolonged periods. Over-sedation and under-sedation both have negative effects on patient safety and resource use. We conducted a systematic review of the literature in order to establish the incidence of sub-optimal sedation (both over- and under-sedation) in ICUs.
We searched Medline, Embase and CINAHL (Cumulative Index to Nursing and Allied Health Literature) online literature databases from 1988 to 15 May 2008 and hand-searched conferences. English-language studies set in the ICU, in sedated adult humans on mechanical ventilation, which reported the incidence of sub-optimal sedation, were included. All abstracts were reviewed twice by two independent reviewers, with all conflicts resolved by a third reviewer, to check that they met the review inclusion criteria. Full papers of all included studies were retrieved and were again reviewed twice against inclusion criteria. Data were doubly extracted. Study aims, design, population, comparisons made, and data on the incidence of sub-optimal, optimal, over-sedation or under-sedation were extracted.
There was considerable variation between included studies in the definition of optimal sedation and in the scale or method used to assess sedation. Across all included studies, a substantial incidence of sub-optimal sedation was reported, with a greater tendency toward over-sedation.
Our review suggests that improvements in the consistent definition and measurement of sedation may improve the quality of care of patients within the ICU.
PMCID: PMC2811948  PMID: 20015357
24.  Intravenous sedation in accident and emergency departments: a nationwide survey. 
Anonymous questionnaires regarding the practice of intravenous sedation were sent to all accident and emergency departments in England and Wales. The response rate was 63%. Intravenous sedation was used by 94% of the departments who replied. In 19% of these departments it was administered only by middle grade or senior grade clinicians, while in the remaining 81% sedation was also administered by junior grade clinicians. Diazepam, midazolam and opioids were the most commonly used agents. The use of monitoring was variable. In 16% of the units no monitoring was used routinely. ECG monitoring was carried out by 48% of the departments, non-invasive blood pressure monitoring by 67% and pulse oximetry by 65%. Our findings indicate there is a need for guidelines regarding patient selection, the choice of drugs and the monitoring of patients.
PMCID: PMC2502195  PMID: 7906931
25.  Effects of auditing patient safety in hospital care: design of a mixed-method evaluation 
Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects.
Methods and design
Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011–July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects.
We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to early detect unsafe care and improve patient safety continuously.
Trial registration
Netherlands Trial Register (NTR): NTR3343
PMCID: PMC3708817  PMID: 23800253
Hospital; Patient safety; Safety management; Risk management; Complications; Management system audit; Clinical governance; Professional practice; Adverse events; Auditing

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