LITES Task Order 0005 Prehospital Airway Control Trial (PACT)
Trial Parameters
Brief Summary
The Prehospital Airway Control Trial (PACT) is a proposed 5 year, open label, multi-center, stepped-wedge randomized trial comparing airway management strategies of prehospital trauma patients. The initial airway attempt will be randomized to either usual care (control) or a supraglottic airway management approach (intervention). The primary outcome will be 24 hour survival, with secondary outcomes to include survival to hospital discharge, expected clinical adverse events, airway management performance, ICU length of stay, ventilator days, incidence of ARDS, and incidence of ventilator associated pneumonia. Subjects will be enrolled across approximately 17 prehospital agencies at select LITES Network sites and will enroll a total of 2,009 subjects.
Eligibility Criteria
Inclusion Criteria: 1. Traumatic injury requiring advanced airway management. Indicators of need for advanced airway management include: a) GCS\<8, b) SpO2\<90 despite supplemental oxygen, b) ETCO2\>60 despite supplemental ventilation, or d) provider discretion. 2. Transport (or intended transport) to an enrolling LITES Trauma Center Exclusion Criteria: 1. \< 15 years of age 2. Known pregnancy 3. Known prisoner 4. Initial advanced airway attempted by a non-PACT provider. 5. Cardiac Arrest without return of spontaneous circulation (ROSC) at the time of the intervention 6. Caustic substance ingestion 7. Airway burns 8. Objection to study voiced by subject or family member at the scene. Inclusion and exclusion criteria will be assessed based on information available at the time of enrollment, defined as the time at which enrolling agency provides positive pressure ventilation support. Although all reasonable efforts will be made by the emergency medical crew to either directly witness or