Status:
RECRUITING
LITES Task Order 0005 Prehospital Airway Control Trial (PACT)
Lead Sponsor:
Jason Sperry
Collaborating Sponsors:
United States Department of Defense
Conditions:
Trauma Injury
Airway Control
Eligibility:
All Genders
15+ years
Phase:
NA
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 in...
Eligibility Criteria
Inclusion
- 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.
- Transport (or intended transport) to an enrolling LITES Trauma Center
Exclusion
- \< 15 years of age
- Known pregnancy
- Known prisoner
- Initial advanced airway attempted by a non-PACT provider.
- Cardiac Arrest without return of spontaneous circulation (ROSC) at the time of the intervention
- Caustic substance ingestion
- Airway burns
- 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.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
2009 Patients enrolled
Trial Details
Trial ID
NCT04100564
Start Date
April 1 2021
End Date
January 1 2027
Last Update
November 20 2025
Active Locations (14)
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1
Emory University
Atlanta, Georgia, United States, 30303
2
Mount Sinai Hospital
Chicago, Illinois, United States, 60608
3
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
4
John H. Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612