LITES Task Order 0005 Prehospital Airway Control Trial (PACT) (PACT)
Trauma Injury, Airway Control
About this trial
This is an interventional treatment trial for Trauma Injury focused on measuring intubation, supraglottic airway
Eligibility Criteria
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.
- Transport (or intended transport) to an enrolling LITES Trauma Center
Exclusion Criteria:
- < 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.
Sites / Locations
- Emory University
- Mount Sinai Hospital
- Northwestern Memorial Hospital
- John H. Stroger Hospital of Cook County
- University of Chicago
- University of Louisville
- Tulane University
- Washington University at St. Louis
- East Carolina University
- Oregon Health & Science University
- Allegheny General Hospital
- University of Pittsburgh
- UPMC
- Vanderbilt University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard airway method arm
Supraglottic airway method arm
Standard airway management strategy
Supraglottic first airway management strategy