LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

  • STATUS
    Recruiting
  • End date
    Aug 31, 2024
  • participants needed
    2040
  • sponsor
    Jason Sperry
Updated on 15 June 2021

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 24 prehospital agencies at select LITES Network sites and will enroll a total of 2,040 subjects.

Details
Condition Airway Management, Trauma Injury, Injury Trauma
Treatment supraglottic airway device, Standard airway management
Clinical Study IdentifierNCT04100564
SponsorJason Sperry
Last Modified on15 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Trauma 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
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