Traumatic brain injury (TBI) exacts a great toll on society. Fortunately, there is growing evidence that the management of TBI in the early minutes after injury may significantly reduce morbidity and mortality. In response, evidence-based prehospital and in-hospital TBI treatment guidelines have been established by authoritative bodies. However, no large studies have yet evaluated the effectiveness of implementing these guidelines in the prehospital setting. This article describes the background, design, implementation, emergency medical services (EMS) treatment protocols, and statistical analysis of a prospective, controlled (before/after), statewide study designed to evaluate the effect of implementing the EMS TBI guidelines—the Excellence in Prehospital Injury Care (EPIC) study (NIH/NINDS R01NS071049, “EPIC”; and 3R01NS071049-S1, “EPIC4Kids”).
The specific aim of the study is to test the hypothesis that statewide implementation of the international adult and pediatric EMS TBI guidelines will significantly reduce mortality and improve nonmortality outcomes in patients with moderate or severe TBI. Furthermore, it will specifically evaluate the effect of guideline implementation on outcomes in the subgroup of patients who are intubated in the field. Over the course of the entire study (~9 years), it is estimated that approximately 25,000 patients will be enrolled.
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BACKGROUND:
Hypoxia (HOx) or hypotension (HT) occurring during the EMS management of major traumatic brain injury-TBI reduces survival. However, little is known about the impact of both HOx and HT, occurring together, on outcome. Only a handful of reports have studied the combination of prehospital HOx/HT in TBI and the largest of these only had 14 cases with both.
Objectives:
To evaluate the associations between mortality and prehospital HOx and HT, both separately and in combination.
METHODS:
All moderate/severe TBI cases (CDC Barell Matrix Type-1) in the Excellence in Prehospital Injury Care (EPIC) TBI Study (a statewide, before/after controlled study of the impact of implementing the EMS TBI Treatment Guidelines-NIH/NINDS: 1R01NS071049) from 1/1/08-6/30/12 were evaluated [exclusions: age<10; death before ED arrival; EMS O2 saturation-“sat”<11%; EMS SBP less than 40 or greater than 200; missing sat (5.4% of cases) or SBP (3.1% of cases)]. The relationship between mortality and HOx (sat <90) and/or HT (SBP<90) was assessed with crude and adjusted odds ratios (cOR, aOR) using multivariable logistic regression, controlling for important confounders (see Figure) and accounting for clustering by Trauma Center.
RESULTS:
9194 cases were included [Median age: 46 (IQR: 26-65); Male: 68.1%]. 8109 (88.2%) had no HOx/HT, 535 (5.8%) had HOx only, 419 (4.6%) had HT only, and 131 (1.4%) had both HOx/HT. The Figure shows the cORs and aORs for death.
CONCLUSION:
In this large analysis of major TBI, prehospital HOx and HT were associated with significantly increased mortality. However, the combination of HT and HOx together had a profoundly-negative effect on survival even after controlling for significant confounders. In fact, the aOR for death in patients with both HOx/HT was more than 3 times greater than for those with HOx or HT alone. Since the TBI Guidelines emphasize the prevention and treatment of HOx and HT, their implementation has the potential to significantly impact outcome.
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