Out-of-hospital hypertonic resuscitation following severe traumatic brain injury: a randomized controlled trial.

CONTEXT: Hypertonic fluids restore cerebral perfusion with reduced cerebral edema and modulate inflammatory response to reduce subsequent neuronal injury and thus have potential benefit in resuscitation of patients with traumatic brain injury (TBI). OBJECTIVE: To determine whether out-of-hospital administration of hypertonic fluids improves neurologic outcome following severe TBI. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, double-blind, randomized, placebo-controlled clinical trial involving 114 North American emergency medical services agencies within the Resuscitation Outcomes Consortium, conducted between May 2006 and May 2009 among patients 15 years or older with blunt trauma and a prehospital Glasgow Coma Scale score of 8 or less who did not meet criteria for hypovolemic shock. Planned enrollment was 2122 patients. INTERVENTION: A single 250-mL bolus of 7.5% saline/6% dextran 70 (hypertonic saline/dextran), 7.5% saline (hypertonic saline), or 0.9% saline (normal saline) initiated in the out-of-hospital setting. MAIN OUTCOME MEASURE: Six-month neurologic outcome based on the Extended Glasgow Outcome Scale (GOSE) (dichotomized as >4 or ≤4). RESULTS: The study was terminated by the data and safety monitoring board after randomization of 1331 patients, having met prespecified futility criteria. Among the 1282 patients enrolled, 6-month outcomes data were available for 1087 (85%). Baseline characteristics of the groups were equivalent. There was no difference in 6-month neurologic outcome among groups with regard to proportions of patients with severe TBI (GOSE ≤4) (hypertonic saline/dextran vs normal saline: 53.7% vs 51.5%; difference, 2.2% [95% CI, -4.5% to 9.0%]; hypertonic saline vs normal saline: 54.3% vs 51.5%; difference, 2.9% [95% CI, -4.0% to 9.7%]; P = .67). There were no statistically significant differences in distribution of GOSE category or Disability Rating Score by treatment group. Survival at 28 days was 74.3% with hypertonic saline/dextran, 75.7% with hypertonic saline, and 75.1% with normal saline (P = .88). CONCLUSION: Among patients with severe TBI not in hypovolemic shock, initial resuscitation with either hypertonic saline or hypertonic saline/dextran, compared with normal saline, did not result in superior 6-month neurologic outcome or survival. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00316004.

The out-of-hospital validation of the Canadian C-Spine Rule by paramedics.

STUDY OBJECTIVE: We designed the Canadian C-Spine Rule for the clinical clearance of the cervical spine, without need for diagnostic imaging, in alert and stable trauma patients. Emergency physicians previously validated the Canadian C-Spine Rule in 8,283 patients. This study prospectively evaluates the performance characteristics, reliability, and clinical sensibility of the Canadian C-Spine Rule when used by paramedics in the out-of-hospital setting. METHODS: We conducted this prospective cohort study in 7 Canadian regions and involved alert (Glasgow Coma Scale score 15) and stable adult trauma patients at risk for neck injury. Advanced and basic care paramedics interpreted the Canadian C-Spine Rule status for all patients, who then underwent immobilization and assessment in the emergency department to determine the outcome, clinically important cervical spine injury. RESULTS: The 1,949 patients enrolled had these characteristics: median age 39.0 years (interquartile range 26 to 52 years), female patients 50.8%, motor vehicle crash 62.5%, fall 19.9%, admitted to the hospital 10.8%, clinically important cervical spine injury 0.6%, unimportant injury 0.3%, and internal fixation 0.3%. The paramedics classified patients for 12 important injuries with sensitivity 100% (95% confidence interval [CI] 74% to 100%) and specificity 37.7% (95% CI 36% to 40%). The kappa value for paramedic interpretation of the Canadian C-Spine Rule (n=155) was 0.93 (95% CI 0.87 to 0.99). Paramedics conservatively misinterpreted the rule in 320 (16.4%) patients and were comfortable applying the rule in 1,594 (81.7%). Seven hundred thirty-one (37.7%) out-of-hospital immobilizations could have been avoided with the Canadian C-Spine Rule. CONCLUSION: This study found that paramedics can apply the Canadian C-Spine Rule reliably, without missing any important cervical spine injuries. The adoption of the Canadian C-Spine Rule by paramedics could significantly reduce the number of out-of-hospital cervical spine immobilizations.

The OPALS Major Trauma Study: impact of advanced life-support on survival and morbidity.

BACKGROUND: To date, the benefit of prehospital advanced life-support programs on trauma-related mortality and morbidity has not been established METHODS: The Ontario Prehospital Advanced Life Support (OPALS) Major Trauma Study was a before-after systemwide controlled clinical trial conducted in 17 cities. We enrolled adult patients who had experienced major trauma in a basic life-support phase and a subsequent advanced life-support phase (during which paramedics were able to perform endotracheal intubation and administer fluids and drugs intravenously). The primary outcome was survival to hospital discharge. RESULTS: Among the 2867 patients enrolled in the basic life-support (n = 1373) and advanced life-support (n = 1494) phases, characteristics were similar, including mean age (44.8 v. 47.5 years), frequency of blunt injury (92.0% v. 91.4%), median injury severity score (24 v. 22) and percentage of patients with Glasgow Coma Scale score less than 9 (27.2% v. 22.1%). Survival did not differ overall (81.1% among patients in the advanced life-support phase v. 81.8% among those in the basic life-support phase; p = 0.65). Among patients with Glasgow Coma Scale score less than 9, survival was lower among those in the advanced life-support phase (50.9% v. 60.0%; p = 0.02). The adjusted odds of death for the advanced life-support v. basic life-support phases were nonsignificant (1.2, 95% confidence interval 0.9-1.7; p = 0.16). INTERPRETATION: The OPALS Major Trauma Study showed that systemwide implementation of full advanced life-support programs did not decrease mortality or morbidity for major trauma patients. We also found that during the advanced life-support phase, mortality was greater among patients with Glasgow Coma Scale scores less than 9. We believe that emergency medical services should carefully re-evaluate the indications for and application of prehospital advanced life-support measures for patients who have experienced major trauma.