NCT04100564CompletedNot Applicable
Prehospital Airway Control Trial : A Randomized Controlled Trial of Prehospital Airway Management Strategy for Trauma Patients
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Jason Sperry
- Enrollment
- 2,010
- Locations
- 17
- Primary Endpoint
- 24-hour survival
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- 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.
- •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.
Arms & Interventions
Standard airway method arm
Active Comparator
Standard airway management strategy
Intervention: Standard airway management (Other)
Supraglottic airway method arm
Experimental
Supraglottic first airway management strategy
Intervention: Supraglottic airway device (Device)
Outcomes
Primary Outcomes
24-hour survival
Time Frame: From injury through 24 hours
Secondary Outcomes
- ICU length of stay(Admission through 30 days or discharge)
- Ventilator days(Admission through 30 days or discharge)
- Incidence of hypotension(At the time of placement of device through time of arrival to trauma bay)
- Rate of first pass success of placement of advanced airway device(At time of placement of device through confirmation of device placement)
- Incidence of expected adverse events(From initial airway management through first 24 hours of hospital admission)
- Incidence of need for rescue airway device(At the time of placement of device through time of arrival to trauma bay)
- Proportion of subjects that survive to hospital discharge(From hospital admission through death or hospital discharge up to 30 days)
- Incidence of hypoxia(At the time of placement of device through time of arrival to trauma bay)
Investigators
Jason Sperry
Professor
University of Pittsburgh
Study Sites (17)
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