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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,010
Initial advanced airway management with a supraglottic device
Initial advanced airway management with standard care method
Emory University
Atlanta, Georgia, United States
Mount Sinai Hospital
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
John H. Stroger Hospital of Cook County
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Tulane University
New Orleans, Louisiana, United States
Washington University at St. Louis
St Louis, Missouri, United States
East Carolina University
Greenville, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
...and 4 more locations
24-hour survival
Time frame: From injury through 24 hours
Proportion of subjects that survive to hospital discharge
Time frame: From hospital admission through death or hospital discharge up to 30 days
Rate of first pass success of placement of advanced airway device
Time frame: At time of placement of device through confirmation of device placement
ICU length of stay
Time frame: Admission through 30 days or discharge
Ventilator days
Time frame: Admission through 30 days or discharge
Incidence of expected adverse events
Time frame: From initial airway management through first 24 hours of hospital admission
Incidence of need for rescue airway device
Time frame: At the time of placement of device through time of arrival to trauma bay
Incidence of hypoxia
Time frame: At the time of placement of device through time of arrival to trauma bay
Incidence of hypotension
Time frame: At the time of placement of device through time of arrival to trauma bay
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.