LITES Task Order 0005 Prehospital Airway Control Trial (PACT)
Purpose
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.
Conditions
- Trauma Injury
- Airway Control
Eligibility
- Eligible Ages
- Over 15 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- < 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 obtain documentation of inclusion criteria, due to the nature of the emergency prehospital setting, there may be occasions where the emergency medical crew must rely on verbal report of inclusion criteria from referring hospital or emergency crew. In these instances, if, after subsequent review of outside hospital and/or ground crew documentation, it is determined that the subject did not meet inclusion criteria and/or met exclusion criteria, the subject will remain enrolled in the study based on the intention-to-treat principle. If a verbal report must be used in lieu of physical documentation or directly witnessing inclusion criteria, documentation of the verbal report will serve as the source documentation for determining eligibility. Verbal reports will be documented in the emergency medical record and will detail the information provided and by whom.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Stepped-wedge
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Standard airway method arm |
Standard airway management strategy |
|
|
Experimental Supraglottic airway method arm |
Supraglottic first airway management strategy |
|
Recruiting Locations
Tulane University
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Contact:
Juan Duchesne, MD
Juan Duchesne, MD
More Details
- Status
- Recruiting
- Sponsor
- Jason Sperry