Background

A new adjustable valve, the Codman CertasTM valve for treatment of hydrocephalus was introduced into clinical practice in January 2011. It has 8 different settings with an opening pressure varying from 36 to over 400 mm H2O at a flow rate of 20 mL/h. The 8th setting is designed to provide a "virtual off" function. The objective of this report is to describe the initial clinical experience with the CertasTM valve and evaluate clinical usage with the main focus on the portable adjustment device - Therapeutic Management System (TMS), the “virtual off” setting and compatibility with magnetic resonance imaging (MRI).

Findings

Forty-two patients with hydrocephalus from different etiologies were treated with the CertasTM adjustable shunt system. Data regarding implantation procedures, the use of the TMS system, x-ray imaging, and MRI procedures were recorded prospectively. All patients had clinical follow-up at four weeks after implantation and every three months until a stable clinical condition was obtained.

The mean time for follow-up was 8.6 months (1–16.6). Seventy-one adjustments were performed with the TMS, 12 were problematic. Twenty-nine MRI procedures were performed and did not cause accidental resetting. Five patients were treated with the "virtual off" function for a period.

Conclusions

We found the CertasTM valve valuable in the treatment of hydrocephalus, usability of the TMS was high because it is small and portable, but in some cases we experienced adjustment problems with the first procedures performed by a surgeon, indicating that there is a learning curve. The "virtual off" function provided a possibility of treating over-drainage without the need for shunt ligation or other invasive procedures.

Background

One of the main causes of mortality and morbidity following subarachnoid haemorrhage (SAH) is the development of cerebral vasospasm, a frequent complication arising in the weeks after the initial bleeding. Despite extensive research, to date no effective treatment of vasospasm exists. Prostacyclin is a potent vasodilator and inhibitor of platelet aggregation. In vitro models have shown a relaxing effect of prostacyclin after induced contraction in cerebral arteries, and a recent pilot trial showed a positive effect on cerebral vasospasm in a clinical setting. No randomised, clinical trials have been conducted, investigating the possible pharmacodynamic effects of prostacyclin on the human brain following SAH.

Methods

This trial is a single-centre, randomised, placebo-controlled, parallel group, blinded, clinical, pilot trial. A total of 90 patients with SAH will be randomised to one of three intervention arms: epoprostenol 1 ng/kg/min, epoprostenol 2 ng/kg/min or placebo in addition to standard treatment. Trial medication will start day 5 after SAH and continue to day 10. The primary outcome measure is changes in regional cerebral blood flow from baseline in the arterial territories of the anterior cerebral artery, medial cerebral artery and the posterior cerebral artery, measured by CT perfusion scan. The secondary outcomes will be vasospasm measured by CT angiography, ischaemic parameters measured by brain microdialysis, flow velocities in the medial cerebral artery, clinical parameters and outcome (Glasgow Outcome Scale) at 3 months.

Trial registration

Clinicaltrials.gov NCT01447095.

Background

The Scandinavian guidelines for management of minimal, mild and moderate head injuries were developed to provide safe and cost effective assessment of head injured patients. In a previous study conducted one year after publication and implementation of the guidelines (2003), we showed low compliance, involving over-triage with computed tomography (CT) and hospital admissions. The aim of the present study was to investigate guideline compliance after an educational intervention.

Methods

We evaluated guideline compliance in the management of head injured patients referred to the University Hospital of Stavanger, Norway. The findings from the previous study in 2003 were communicated to the hospitals physicians, and a feed-back loop training program for guideline implementation was conducted. All patients managed during the months January through June in the years 2005, 2007 and 2009 were then identified with an electronic search in the hospitals patient administrative database, and the patient files were reviewed. Patients were classified according to the Head Injury Severity Scale, and the management was classified as compliant or not with the guideline.

Results

The 1 180 patients were 759 (64%) males and 421 (36%) females with a mean age of 31.5 (range 0-97) years. Over all, 738 (63%) patients were managed in accordance with the guidelines and 442 (37%) were not. Compliance was not significantly different between minimal (56%) and mild (59%) injuries, while most moderate (93%) injuries were managed in accordance with the guidelines (p < 0.05). Noncompliance was caused by overtriage in 362 cases (30%) and undertriage in 80 (7%). Guideline compliance was 54% in 2005, 71% in 2007, and 64% in 2009.

Conclusions

This study shows higher guideline compliance after an educational intervention involving feed-back on performance. A substantial number of patients are exposed to over-triage, involving unnecessary radiation from CT examinations, and unnecessary costs from hospital admissions.

Background

In 2000 the Scandinavian Neurotrauma Committee published guidelines for safe and cost-effective management of minimal, mild and moderate head injured patients.

The aims of this study were to investigate to what extent the head injury population is under the influence of alcohol, and to evaluate whether the physicians' compliance to the guidelines is affected when patients are influenced by alcohol.

Methods

This study included adult patients (≥15 years) referred to a Norwegian University Hospital with minimal, mild and moderate head injuries classified according to the Head Injury Severity Scale (HISS). Information on alcohol consumption was recorded, and in most of these patients blood alcohol concentration (BAC) was measured. Compliance with the abovementioned guidelines was registered.

Results

The study includes 860 patients. 35.8% of the patients had consumed alcohol, and 92.1% of these patients had a BAC ≥ 1.00‰. Young age, male gender, trauma occurring during the weekends, mild and moderate head injuries were independent factors significantly associated with being under the influence of alcohol. Guideline compliance was 60.5%, and over-triage was the main violation. The guideline compliance showed no significant correlation to alcohol consumption or to BAC-level.

Conclusions

This study confirms that alcohol consumption is common among patients with head injuries. The physicians' guideline compliance was not affected by the patients' alcohol consumption, and alcohol influence could therefore not explain the low guideline compliance.

Background

Protein S100B has proven to be a useful biomarker for cerebral damage. The predictive ability of S100B may, however, be affected by extracerebral injuries. The aim of this study was to investigate serum levels of S100B in patients with either isolated head injury (IHI), multi trauma with head injury (MTHI), or no head injury (NHI). The primary aim was to assess if a significant difference in serum levels of S100B could be found between IHI and MTHI patients.

Methods

Patients (233) were primarily admitted to the trauma centre. Serum samples were drawn on admission and 6 h after trauma and then stored at −80°C until analysed. Variables included Abbreviated Injury Scale (AIS) for head trauma, Injury Severity Score (ISS) and 30-day survival.

Results

Two patients could not be classified. IHI occurred in 28, MTHI in 102 and NHI was found in 101. The median S100B concentrations on arrival were 0.47, 1.68 and 0.49 μg/l, respectively (p<0.0001). The corresponding values at 6 h were 0.14, 0.31 and 0.15 μg/l, respectively (p<0.0001). S100B was significantly higher in patients with MTHI than in patients with IHI at both time points (p values 0.0005 and 0.01). There was no significant difference in S100B between patients having IHI and patients with NHI (p=0.81 and p=0.67).

Conclusions

High serum levels of S100B were found early after trauma. The highest concentrations of S100B were found in patients with multi trauma. This suggests that S100B serum concentrations are significantly affected by extracerebral injuries.

Objectives

To evaluate the effect of an educational intervention on outcome after minimal, mild and moderate head injury.

Methods

Three hundred and twenty six patients underwent stratified randomization to an intervention group (n = 163) or a control group (n = 163). Every second patient was allocated to the intervention group. Participants in this group were offered a cognitive oriented consultation two weeks after the injury, while subjects allocated to the control group were not. Both groups were invited to follow up 3 and 12 months after injury.

Results

A total of 50 (15%) patients completed the study (intervention group n = 22 (13%), control group n = 28 (17%), not significant). There were no statistically significant differences between the intervention group and the control group.

Conclusions

There was no effect on outcomes from an early educational intervention two weeks after head injury.

Background

In three previous Norwegian studies conducted between 1974 and 1993, the annual incidence rates of hospital admitted head injuries were 236, 200 and 169 per 100,000 population. The aim of this study was to describe the incidence of head injury in the Stavanger region and to compare it with previous Norwegian studies.

Methods

All head injured patients referred to Stavanger University Hospital during a one-year period (2003) were registered in a partly prospective and partly retrospective study. The catchment area for the hospital is strictly defined to a local population of 283,317 inhabitants (2003).

Results

The annual incidence rate was 207/100,000 population for hospital referred head injury and 157/100,000 population for hospital admitted head injury. High age- and sex specific incidence rates were observed among the oldest, and the highest rate (882/100,000) among men above 90 years. More than 50% of the injuries were caused by falls.

Conclusion

Comparison with previous Norwegian studies indicates decreasing annual incidence rates for hospital admitted head injury during the last 30 years.

Objective To assess the efficacy of caudal epidural steroid or saline injection in chronic lumbar radiculopathy in the short (6 weeks), intermediate (12 weeks), and long term (52 weeks).

Design Multicentre, blinded, randomised controlled trial.

Setting Outpatient multidisciplinary back clinics of five Norwegian hospitals.

Participants Between October 2005 and February 2009, 461 patients assessed for inclusion (presenting with lumbar radiculopathy >12 weeks). 328 patients excluded for cauda equina syndrome, severe paresis, severe pain, previous spinal injection or surgery, deformity, pregnancy, ongoing breast feeding, warfarin therapy, ongoing treatment with non-steroidal anti-inflammatory drugs, body mass index >30, poorly controlled psychiatric conditions with possible secondary gain, and severe comorbidity.

Interventions Subcutaneous sham injections of 2 mL 0.9% saline, caudal epidural injections of 30 mL 0.9% saline, and caudal epidural injections of 40 mg triamcinolone acetonide in 29 mL 0.9% saline. Participants received two injections with a two week interval.

Main outcome measures Primary: Oswestry disability index scores. Secondary: European quality of life measure, visual analogue scale scores for low back pain and for leg pain.

Results Power calculations required the inclusion of 41 patients per group. We did not allocate 17 of 133 eligible patients because their symptoms improved before randomisation. All groups improved after the interventions, but we found no statistical or clinical differences between the groups over time. For the sham group (n=40), estimated change in the Oswestry disability index from the adjusted baseline value was −4.7 (95% confidence intervals −0.6 to −8.8) at 6 weeks, −11.4 (−6.3 to −14.5) at 12 weeks, and −14.3 (−10.0 to −18.7) at 52 weeks. For the epidural saline intervention group (n=39) compared with the sham group, differences in primary outcome were −0.5 (−6.3 to 5.4) at 6 weeks, 1.4 (−4.5 to 7.2) at 12 weeks, and −1.9 (−8.0 to 4.3) at 52 weeks; for the epidural steroid group (n=37), corresponding differences were −2.9 (−8.7 to 3.0), 4.0 (−1.9 to 9.9), and 1.9 (−4.2 to 8.0). Analysis adjusted for duration of leg pain, back pain, and sick leave did not change this trend.

Conclusions Caudal epidural steroid or saline injections are not recommended for chronic lumbar radiculopathy.

Trial registration Current Controlled Trials ISRCTN No 12574253.