LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

Completed · Not applicable

Conditions studied: Trauma Injury, Airway Control

In brief

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.

Key facts

Study ID: NCT04100564
Run by: Jason Sperry
People needed: 2010
Starts: 2021-04-01
Expected to finish: 2026-04-07
Last updated by the study team: 2026-04-14

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

< 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.

Where it is running

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 — St 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
University of Pittsburgh — Pittsburgh, Pennsylvania, United States
UPMC — Pittsburgh, Pennsylvania, United States
Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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