LITES Task Order 0005 Prehospital Airway Control Trial (PACT) (PACT)

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

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 Overview

• Status: Completed
• Conditions: Trauma Injury; Airway Control
• Intervention / Treatment: Other: Standard airway management; Device: Supraglottic airway device

• Study Type: Interventional
• Enrollment (Actual): 2010
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60612
      • John H. Stroger Hospital of Cook County
    • Chicago, Illinois, United States, 60608
      • Mount Sinai Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40208
      • University of Louisville
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University at St. Louis
  • North Carolina
    • Greenville, North Carolina, United States, 27835
      • East Carolina University
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
    • Pittsburgh, Pennsylvania, United States, 15261
      • UPMC
  • Tennessee
    • Nashville, Tennessee, United States, 37235
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard airway method arm; Standard airway management strategy	Other: Standard airway management; Initial advanced airway management with standard care method
Experimental: Supraglottic airway method arm; Supraglottic first airway management strategy	Device: Supraglottic airway device; Initial advanced airway management with a supraglottic device; Other Names: LMA; King; igel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Jason Sperry
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Jason Sperry, MD, MPH, University of Pittsburgh; Principal Investigator: Francis Guyette, MD, MPH, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): March 7, 2026
• Study Completion (Actual): April 7, 2026

Study Registration Dates

• First Submitted: September 11, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: intubation; supraglottic airway
• Additional Relevant MeSH Terms: Wounds and Injuries; Accidental Injuries
• Other Study ID Numbers: STUDY20110369; W81XWH- 16-D- 0024 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No