LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

NCT04100564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2010

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

DEVICE

Supraglottic airway device

Initial advanced airway management with a supraglottic device

OTHER

Standard airway management

Initial advanced airway management with standard care method

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED
  • Jason Sperry

    lead OTHER

Principal Investigators

  • Jason Sperry, MD, MPH · University of Pittsburgh

  • Francis Guyette, MD, MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2026-03-07
Completion
2026-04-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04100564 on ClinicalTrials.gov