LITES Task Order 0005 Prehospital Airway Control Trial (PACT)
- Conditions
- Airway ControlTrauma Injury
- Interventions
- Other: Standard airway managementDevice: Supraglottic airway device
- Registration Number
- NCT04100564
- Lead Sponsor
- Jason Sperry
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2009
- 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
- < 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Standard airway method arm Standard airway management Standard airway management strategy Supraglottic airway method arm Supraglottic airway device Supraglottic first airway management strategy
- Primary Outcome Measures
Name Time Method 24-hour survival From injury through 24 hours
- Secondary Outcome Measures
Name Time Method Incidence of hypotension At the time of placement of device through time of arrival to trauma bay ICU length of stay Admission through 30 days or discharge Ventilator days Admission through 30 days or discharge 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
Trial Locations
- Locations (14)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Mount Sinai Hospital
🇺🇸Chicago, Illinois, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
John H. Stroger Hospital of Cook County
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States
Washington University at St. Louis
🇺🇸Saint Louis, Missouri, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States