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Completed

NCT Number: NCT04100564

LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • < 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.

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.

Treatment and study plan

Supraglottic airway device

Device

Initial advanced airway management with a supraglottic device

Other names: LMA, King, igel

Standard airway management

Other

Initial advanced airway management with standard care method

Primary outcomes

  1. 24-hour survival

    Time frame: From injury through 24 hours

Secondary outcomes

  1. Proportion of subjects that survive to hospital discharge

    Time frame: From hospital admission through death or hospital discharge up to 30 days

  2. Rate of first pass success of placement of advanced airway device

    Time frame: At time of placement of device through confirmation of device placement

  3. ICU length of stay

    Time frame: Admission through 30 days or discharge

  4. Ventilator days

    Time frame: Admission through 30 days or discharge

  5. Incidence of expected adverse events

    Time frame: From initial airway management through first 24 hours of hospital admission

  6. Incidence of need for rescue airway device

    Time frame: At the time of placement of device through time of arrival to trauma bay

  7. Incidence of hypoxia

    Time frame: At the time of placement of device through time of arrival to trauma bay

  8. Incidence of hypotension

    Time frame: At the time of placement of device through time of arrival to trauma bay

Sponsors and collaborators

Lead sponsor

Jason Sperry

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Acronym: PACT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2019
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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