LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

NCT ID: NCT04100564

Last Updated: 2025-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2009 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Trauma Injury Airway Control

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Stepped-wedge
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard airway method arm

Standard airway management strategy

Group Type ACTIVE_COMPARATOR

Standard airway management

Intervention Type OTHER

Initial advanced airway management with standard care method

Supraglottic airway method arm

Supraglottic first airway management strategy

Group Type EXPERIMENTAL

Supraglottic airway device

Intervention Type DEVICE

Initial advanced airway management with a supraglottic device

Interventions

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Supraglottic airway device

Initial advanced airway management with a supraglottic device

Intervention Type DEVICE

Standard airway management

Initial advanced airway management with standard care method

Intervention Type OTHER

Other Intervention Names

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LMA King igel

Eligibility Criteria

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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

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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

Jason Sperry

OTHER

Sponsor Role lead

Responsible Party

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Jason Sperry

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jason Sperry, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Francis Guyette, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Mount Sinai Hospital

Chicago, Illinois, United States

Site Status RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status RECRUITING

John H. Stroger Hospital of Cook County

Chicago, Illinois, United States

Site Status RECRUITING

University of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

University of Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

Tulane University

New Orleans, Louisiana, United States

Site Status RECRUITING

Washington University at St. Louis

St Louis, Missouri, United States

Site Status COMPLETED

East Carolina University

Greenville, North Carolina, United States

Site Status RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

UPMC

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Vanderbilt University

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jason Sperry, MD, MPH

Role: CONTACT

412 802 8270

Facility Contacts

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David Wright, MD

Role: primary

Grace Chang, MD

Role: primary

Michael Shapiro, MD

Role: primary

Leah Tatebe, MD

Role: primary

Katie Tataris, MD

Role: primary

Brian G Harbrecht, MD

Role: primary

Sharven Taghavi, MD

Role: primary

Joanna Adams, MD

Role: primary

Mohamud Daya, MD

Role: primary

Jestin Carlson, MD

Role: primary

Jason L Sperry, MD,MPH

Role: primary

4126473065

Neal Richmond, MD

Role: primary

Other Identifiers

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W81XWH- 16-D- 0024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY20110369

Identifier Type: -

Identifier Source: org_study_id

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