LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

Description

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.

Conditions

Trauma Injury, Airway Control

Study Overview

Study Details

Study overview

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.

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

LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

Condition
Trauma Injury
Intervention / Treatment

-

Contacts and Locations

Atlanta

Emory University, Atlanta, Georgia, United States, 30303

Chicago

Mount Sinai Hospital, Chicago, Illinois, United States, 60608

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Chicago

John H. Stroger Hospital of Cook County, Chicago, Illinois, United States, 60612

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Louisville

University of Louisville, Louisville, Kentucky, United States, 40208

New Orleans

Tulane University, New Orleans, Louisiana, United States, 70112

Saint Louis

Washington University at St. Louis, Saint Louis, Missouri, United States, 63110

Greenville

East Carolina University, Greenville, North Carolina, United States, 27835

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

15 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Jason Sperry,

Jason Sperry, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Francis Guyette, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2026-03-31