LITES Task Order 0005 Prehospital Airway Control Trial (PACT)
Prehospital Airway Control Trial : A Randomized Controlled Trial of Prehospital Airway Management Strategy for Trauma Patients
Jason Sperry
2,009 participants
Apr 1, 2021
INTERVENTIONAL
Conditions
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 17 prehospital agencies at select LITES Network sites and will enroll a total of 2,009 subjects.
Eligibility
Inclusion Criteria2
- 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 Criteria8
- \< 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.
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Interventions
Initial advanced airway management with a supraglottic device
Initial advanced airway management with standard care method
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04100564