The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only.

BACKGROUND: Advanced prehospital interventions for severe brain injury remains controversial. No previous randomised trial has been conducted to evaluate additional physician intervention compared with paramedic only care. METHODS: Participants in this prospective, randomised controlled trial were adult patients with blunt trauma with either a scene GCS score <9 (original definition), or GCS<13 and an Abbreviated Injury Scale score for the head region ≥3 (modified definition). Patients were randomised to either standard ground paramedic treatment or standard treatment plus a physician arriving by helicopter. Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale (GOS) scores. Due to high non-compliance rates, both intention-to-treat and as-treated analyses were preplanned. RESULTS: 375 patients met the original definition, of which 197 was allocated to physician care. Differences in the 6-month GOS scores were not significant on intention-to-treat analysis (OR 1.11, 95% CI 0.74 to 1.66, p=0.62) nor was the 30-day mortality (OR 0.91, 95% CI 0.60 to 1.38, p=0.66). As-treated analysis showed a 16% reduction in 30-day mortality in those receiving additional physician care; 60/195 (29%) versus 81/180 (45%), p<0.01, Number needed to treat =6. 338 patients met the modified definition, of which 182 were allocated to physician care. The 6-month GOS scores were not significantly different on intention-to-treat analysis (OR 1.14, 95% CI 0.73 to 1.75, p=0.56) nor was the 30-day mortality (OR 1.05, 95% CI 0.66 to 1.66, p=0.84). As-treated analyses were also not significantly different. CONCLUSIONS: This trial suggests a potential mortality reduction in patients with blunt trauma with GCS<9 receiving additional physician care (original definition only). Confirmatory studies which also address non-compliance issues are needed. TRIAL REGISTRATION NUMBER: NCT00112398.

The study protocol for the Head Injury Retrieval Trial (HIRT): a single centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics.

BACKGROUND: The utility of advanced prehospital interventions for severe blunt traumatic brain injury (BTI) remains controversial. Of all trauma patient subgroups it has been anticipated that this patient group would most benefit from advanced prehospital interventions as hypoxia and hypotension have been demonstrated to be associated with poor outcomes and these factors may be amenable to prehospital intervention. Supporting evidence is largely lacking however. In particular the efficacy of early anaesthesia/muscle relaxant assisted intubation has proved difficult to substantiate. METHODS: This article describes the design and protocol of the Head Injury Retrieval Trial (HIRT) which is a randomised controlled single centre trial of physician prehospital care (delivering advanced interventions such as rapid sequence intubation and blood transfusion) in addition to paramedic care for severe blunt TBI compared with paramedic care alone. RESULTS: Primary endpoint is Glasgow Outcome Scale score at six months post injury. Issues with trial integrity resulting from drop ins from standard care to the treatment arm as the result of policy changes by the local ambulance system are discussed. CONCLUSION: This randomised controlled trial will contribute to the evaluation of the efficacy of advance prehospital interventions in severe blunt TBI. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00112398.

Risk factors for complications during intracranial electrode recording in presurgical evaluation of drug resistant partial epilepsy.

BACKGROUND: Intracranial electrode monitoring is still required in epilepsy surgery; however, it is associated with significant morbidity. OBJECTIVE: To identify risk factors associated with complications during invasive intracranial EEG monitoring. MATERIALS AND METHODS: Retrospective study of all patients undergoing invasive monitoring at Westmead between 1988-2004. From detailed chart reviews, the following variables were recorded: duration of intracranial monitoring, the site of grid implantation, number of grids and electrodes, seizure frequency, postoperative complications and seizure outcome. RESULTS: Seventy-one patients (median age: 24 years) underwent subdural electrode implantation; 62% had extratemporal lobe epilepsy and 46% were non-lesional. Of the 58 monitored patients who had cortical resections, 45 had good seizure outcomes. Complications related to subdural electrode implantation included transient complications requiring no treatment (12.7%), transient complications requiring treatment (9.9%) and two deaths (2.8%). Specific complications included subdural haemorrhage, transient neurological deficit, infarction and osteomyelitis. The two deaths occurred within 48 h of implantation were related to raised intracranial pressure (one venous infarction, one unexplained). Complications were associated with maximal size of grid (p < 0.001), greater number of electrodes (p < 0.001), electrode density per cortical surface implanted (p < 0.001), right central surface implantation (p = 0.003) and left central surface implantation (p = 0.013). Multiple logistic regression identified larger size grids and right central surface implantation as independent predictors of complications. CONCLUSION: There are significant complications during intracranial EEG evaluations but the majority of these are transient. We found a relationship between the size of the electrode arrays and the incidence of complications. The results of this study have been used to modify our implantation and monitoring protocols.

Protein S-100 and neuropsychological functioning following severe traumatic brain injury.

PRIMARY OBJECTIVE: To examine the relationship between serum concentrations of protein S-100beta and neuropsychological functioning following severe traumatic brain injury. DESIGN: Matched control group. METHODS: Blood samples were taken within 12 hours of injury and then daily up to 7 days post-injury (n=23). Within 2 weeks of emerging from post-traumatic amnesia (PTA), participants completed a battery of neuropsychological measures. These results were compared with a matched sample of healthy controls. RESULTS: Early measurement of S-100 not only reflected overall brain injury severity, but also related to neuropsychological deficits, with higher serum concentrations associated with poorer performance across most cognitive domains. PTA duration, measured by the Westmead PTA Scale, was found to be the strongest predictor of S-100 concentration (R2=0.59, p<0.001). CONCLUSIONS: These findings show that measurement of serum protein S-100 may further aid in the identification of individuals with severe TBI who are likely to experience cognitive difficulties.

Cancellation of operations on the day of intended surgery at a major Australian referral hospital.

OBJECTIVE: To establish the rate of and reasons for cancellations of surgery on the scheduled day in an Australian hospital. DESIGN: Prospective survey. SETTING: Major metropolitan tertiary hospital, 13 May to 15 November 2002. MAIN OUTCOME MEASURES: Proportion of operations cancelled on the day of surgery, obtained each day from the operating theatre list and a separate list of additions and cancellations compiled on the day; reasons for cancellations from the cancellation list, extended or confirmed, as necessary, by questioning of bookings and ward staff, or members of the surgical team; estimated and actual duration of each operation and patient information from hospital clinical records. RESULTS: 7913 theatre sessions were scheduled by 133 surgeons in the study period; 941 of these (11.9%) were cancelled on the day, including 724 of 5472 (13.2%) elective procedures on working weekdays. Main reasons for cancellation were: no theatre time due to over-run of previous surgery (18.7%); no postoperative bed (18.1%); cancelled by patient (17.5%); and change in patient clinical status (17.1%). Procedural reasons (including patient not ready, no surgeon, list error, administrative cause, and communication failure) totalled 21.0%. Ear, nose and throat surgery experienced the most cancellations (19.6%), followed by cardiothoracic surgery (15.8%). CONCLUSIONS: There were five major reasons of similar magnitude for on-the-day surgery cancellations. We estimated that 60% of cancellations of elective procedures were potentially avoidable. Change of one factor leading to cancellation (eg, provision of more postoperative beds) is not likely to lead to improvement unless the other major factors are also tackled.

Level of prehospital care and risk of mortality in patients with and without severe blunt head injury.

OBJECTIVES: To determine the association between mortality and the level of prehospital care in severely injured blunt trauma patients with or without severe head injury. METHOD: Retrospective review of 2010 severe blunt trauma patients (injury severity score (ISS) >15) with or without severe head injury in a tiered trauma system involving ambulance officers (basic life support (BLS) and advanced life support (ALS)) and physicians, and a Level 1 trauma centre. RESULTS: After adjusting for age, type of head injury, glasgow coma scale score (GCS), systolic blood pressure, ISS and prehospital time, intensive care unit (ICU) admission modified the association between level of prehospital care and mortality. In those patients without ICU admission, patients in the paramedic and physician-staffed emergency services group were more likely to die than patients in the BLS ambulance group (odds ratio (OR) 2.18, 95% confidence intervals (CI): 1.05-4.55; 4.27, 95% CI: 1.46-12.45, respectively). Among patients who survived to ICU treatment, however, there was no association between level of prehospital care and risk of mortality. Presence or absence of a head injury did not modify the risk of mortality. CONCLUSIONS: The level of prehospital care was associated with the risk of mortality. This was modified by whether the patient survived long enough to be admitted to the ICU.