LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

Jason Sperry

Status: Enrolling

Conditions: Airway Control; Trauma Injury

Treatments: Other: Standard airway management; Device: Supraglottic airway device

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04100564

STUDY20110369

W81XWH- 16-D- 0024 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 2,009 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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2,009 participants in 2 patient groups

Standard airway method arm

Active Comparator group

Description:

Standard airway management strategy

Treatment:

Other: Standard airway management

Supraglottic airway method arm

Experimental group

Description:

Supraglottic first airway management strategy

Treatment:

Device: Supraglottic airway device