Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 15 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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. 2. Transport (or intended transport) to an enrolling LITES Trauma Center

Exclusion Criteria

  1. < 15 years of age 2. Known pregnancy 3. Known prisoner 4. Initial advanced airway attempted by a non-PACT provider. 5. Cardiac Arrest without return of spontaneous circulation (ROSC) at the time of the intervention 6. Caustic substance ingestion 7. Airway burns 8. 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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Stepped-wedge
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard airway method arm
Standard airway management strategy
  • Other: Standard airway management
    Initial advanced airway management with standard care method
Experimental
Supraglottic airway method arm
Supraglottic first airway management strategy
  • Device: Supraglottic airway device
    Initial advanced airway management with a supraglottic device
    Other names:
    • LMA
    • King
    • igel

Recruiting Locations

Tulane University
New Orleans, Louisiana 70112
Contact:
Juan Duchesne, MD

More Details

Status
Recruiting
Sponsor
Jason Sperry

Study Contact

Jason Sperry, MD, MPH
412 802 8270
sperryjl@upmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.