ClinicalTrials.gg
CompletedNCT04100564PACTUpdated Apr 14, 2026

LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

An interventional study of Supraglottic airway device and Standard airway management in Trauma Injury and Airway Control, sponsored by Jason Sperry. Completed at 14 sites in United States. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Jason Sperry · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2,010
Allocation
Randomized
Ages
15 Years and older
Sex
All
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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.

02

Conditions studied

  • Trauma Injury
  • Airway Control

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Keywords

  • intubation
  • supraglottic airway
03

In context

Accidental Injuries

128 studies on the registry are indexed under Accidental Injuries; 39 are open to participants now.

This study's enrollment of 2,010 is above the median of 110 across 67 interventional studies indexed under Accidental Injuries.

Browse Accidental Injuries studies →

Lead sponsor

Jason Sperry is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
2,010 participants (actual)

Study arms

  • Active comparator
    Standard airway method arm

    Standard airway management strategy

    Other: Standard airway management

  • Experimental
    Supraglottic airway method arm

    Supraglottic first airway management strategy

    Device: Supraglottic airway device

Interventions

  • DeviceSupraglottic airway device

    Initial advanced airway management with a supraglottic device

    Also known as: LMA, King, igel

  • OtherStandard airway management

    Initial advanced airway management with standard care method

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What researchers measure

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

07

Study locations

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

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2021 to primary completion in Mar 2026, 59 months.

Of 34 non-industry interventional studies with no phase under Accidental Injuries, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 51. This study's 59 months is above that.

Counting every sponsor, half of 35 studies reached it within 23 months; a quarter within 7 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2019
First posted
Sep 24, 2019
StartActual
Apr 1, 2021
Primary completionActual
Mar 7, 2026
CompletionActual
Apr 7, 2026
Last update
Apr 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04100564
Lead sponsor
Jason Sperry
Collaborators
United States Department of Defense
Responsible party
Jason Sperry (Professor, University of Pittsburgh) — Sponsor-investigator
First posted
Sep 24, 2019
Start date
Apr 1, 2021
Primary completion
Mar 7, 2026
Completion
Apr 7, 2026
Last update
Apr 14, 2026

Study contacts

Jason Sperry, MD, MPH
principal investigator · University of Pittsburgh
Francis Guyette, MD, MPH
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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