Trauma InjuryPACTNCT04100564
LITES Task Order 0005 Prehospital Airway Control Trial (PACT)
A study testing Supraglottic airway device and Standard airway management in people with Trauma Injury and Airway Control, run by Jason Sperry at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Trauma Injury, Airway Control
- What is being tested?
- Supraglottic airway device and Standard airway management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,010 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Apr 2021to 7 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- < 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
Show all 10Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Emory University
Atlanta, Georgia, 30303
Mount Sinai Hospital
Chicago, Illinois, 60608
Northwestern Memorial Hospital
Chicago, Illinois, 60611
John H. Stroger Hospital of Cook County
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
East Carolina University
Greenville, North Carolina, 27835
University of Louisville
Louisville, Kentucky, 40208
Vanderbilt University
Nashville, Tennessee, 37235
Tulane University
New Orleans, Louisiana, 70112
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
UPMC
Pittsburgh, Pennsylvania, 15261
Oregon Health & Science University
Portland, Oregon, 97239
Washington University at St. Louis
St Louis, Missouri, 63110
About this study
Official title: 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.
- Conditions
- Trauma Injury, Airway Control
- Being tested
- Supraglottic airway device, Standard airway management
- Keywords
- intubation, supraglottic airway
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supraglottic airway deviceDevice
Also called LMA, King, igel
Initial advanced airway management with a supraglottic device
Standard airway managementOther
Initial advanced airway management with standard care method
| Study group | Role | What they receive |
|---|---|---|
| Standard airway method arm | Active comparator | Standard airway management strategy Receives: Other: Standard airway management |
| Supraglottic airway method arm | Experimental | Supraglottic first airway management strategy Receives: Device: Supraglottic airway device |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour survival
Measured: From injury through 24 hours
Secondary outcomes (8)
Proportion of subjects that survive to hospital discharge
Measured: From hospital admission through death or hospital discharge up to 30 days
Rate of first pass success of placement of advanced airway device
Measured: At time of placement of device through confirmation of device placement
ICU length of stay
Measured: Admission through 30 days or discharge
Ventilator days
Measured: Admission through 30 days or discharge
Incidence of expected adverse events
Measured: From initial airway management through first 24 hours of hospital admission
Incidence of need for rescue airway device
Measured: At the time of placement of device through time of arrival to trauma bay
Incidence of hypoxia
Measured: At the time of placement of device through time of arrival to trauma bay
Incidence of hypotension
Measured: At the time of placement of device through time of arrival to trauma bay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start1 Apr 2021
- Primary completion7 Mar 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge
- Masking
- None (open label)
- Enrolment
- 2,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jason Sperry
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Jason Sperry, University of Pittsburgh
- Investigators
- Jason Sperry, MD, MPH, Principal investigator, University of PittsburghFrancis Guyette, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100564
- Sponsor's protocol ID
- STUDY20110369
- Other IDs
- W81XWH- 16-D- 0024
- Acronym
- PACT
- Status last verified
- Apr 2026
- First submitted
- 11 Sep 2019
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Airway Control Trial : A Randomized Controlled Trial of Prehospital Airway Management Strategy for Trauma Patients
- ClinicalTrials.gov ID
- NCT04100564
- Acronym / sponsor ID
- PACT / STUDY20110369
- Conditions
- Trauma Injury, Airway Control
- Keywords
- intubation, supraglottic airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,010 participants (actual)
- Lead sponsor
- Jason SperryUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 7 Mar 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge
| Arm | Type | Receives |
|---|---|---|
| Standard airway method arm | Active comparator | Other: Standard airway managementStandard airway management strategy |
| Supraglottic airway method arm | Experimental | Device: Supraglottic airway deviceSupraglottic first airway management strategy |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supraglottic airway deviceAlso: LMA, King, igelInitial advanced airway management with a supraglottic device | Device | Supraglottic airway method arm |
| Standard airway managementInitial advanced airway management with standard care method | Other | Standard airway method arm |
Primary outcome
24-hour survival
Time frame: From injury through 24 hours
8 secondary outcomes
Proportion of subjects that survive to hospital discharge
Time frame: From hospital admission through death or hospital discharge up to 30 days
Rate of first pass success of placement of advanced airway device
Time frame: At time of placement of device through confirmation of device placement
ICU length of stay
Time frame: Admission through 30 days or discharge
Ventilator days
Time frame: Admission through 30 days or discharge
Incidence of expected adverse events
Time frame: From initial airway management through first 24 hours of hospital admission
Incidence of need for rescue airway device
Time frame: At the time of placement of device through time of arrival to trauma bay
Incidence of hypoxia
Time frame: At the time of placement of device through time of arrival to trauma bay
Incidence of hypotension
Time frame: At the time of placement of device through time of arrival to trauma bay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Sperry, MD, MPH principal investigator
University of Pittsburgh
Francis Guyette, MD, MPH principal investigator
University of Pittsburgh
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supraglottic airway device and Standard airway management in people with Trauma Injury and Airway Control, run by Jason Sperry at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour survival (time frame: From injury through 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.