LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

Study Overview
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Brief Summary
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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.

Official Title
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Prehospital Airway Control Trial : A Randomized Controlled Trial of Prehospital Airway Management Strategy for Trauma Patients

Conditions
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Trauma Injury, Airway Control

Intervention / Treatment
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* Device: Supraglottic airway device
* Other: Standard airway management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped-wedge
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard airway method arm<br>Standard airway management strategy | Other: Standard airway management<br>* Initial advanced airway management with standard care method<br>|
| Experimental: Supraglottic airway method arm<br>Supraglottic first airway management strategy | Device: Supraglottic airway device<br>* Initial advanced airway management with a supraglottic device<br>* Other names: igel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour survival |  | From injury through 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects that survive to hospital discharge |  | From hospital admission through death or hospital discharge up to 30 days | 
| Rate of first pass success of placement of advanced airway device |  | At time of placement of device through confirmation of device placement | 
| ICU length of stay |  | Admission through 30 days or discharge | 
| Ventilator days |  | Admission through 30 days or discharge | 
| 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 | 
| Incidence of hypoxia |  | At the time of placement of device through time of arrival to trauma bay | 
| Incidence of hypotension |  | At the time of placement of device through time of arrival to trauma bay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intubation, supraglottic airway