LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

NCT04100564 | Completed DMC FDA Device

• 2 other identifiers: STUDY20110369W81XWH- 16-D- 0024
• Study Type: interventional
• Target: 2,010
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Trauma Injury; Airway Control

Keywords

intubation; supraglottic airway

Outcome Measures

Primary Outcomes (1)

• 24-hour survival

  From injury through 24 hours

Secondary Outcomes (8)

• 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

Study Arms (2)

Standard airway method arm

ACTIVE COMPARATOR

Standard airway management strategy

Other: Standard airway management

Supraglottic airway method arm

EXPERIMENTAL

Supraglottic first airway management strategy

Device: Supraglottic airway device

Interventions

Supraglottic airway device DEVICE

Initial advanced airway management with a supraglottic device

Also known as: LMA, King, igel

Supraglottic airway method arm

Standard airway management OTHER

Initial advanced airway management with standard care method

Standard airway method arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Jason Sperry: lead
• United States Department of Defense: collaborator

Study Sites (14)

Emory University

Atlanta, Georgia, 30303, United States

Location

Mount Sinai Hospital

Chicago, Illinois, 60608, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

John H. Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Louisville

Louisville, Kentucky, 40208, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Washington University at St. Louis

St Louis, Missouri, 63110, United States

Location

East Carolina University

Greenville, North Carolina, 27835, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15261, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

MeSH Terms

Conditions

Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Jason Sperry, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Francis Guyette, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Stepped-wedge

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 24, 2019
• Study Start: April 1, 2021
• Primary Completion: March 7, 2026
• Study Completion: April 7, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)