LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

Trauma Injury Clinical Trial

— PACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04100564
• Other study ID #: STUDY20110369
• Secondary ID: W81XWH- 16-D- 00
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: University of Pittsburgh
• Contact: Jason Sperry, MD, MPH
• Phone: 412 802 8270
• Email: sperryjl[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2009
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Airway Control
• Trauma Injury
• Wounds and Injuries

Intervention

Device:
• Supraglottic airway device
Initial advanced airway management with a supraglottic device

Other:
• Standard airway management
Initial advanced airway management with standard care method

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	John H. Stroger Hospital of Cook County	Chicago	Illinois
United States	Mount Sinai Hospital	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	East Carolina University	Greenville	North Carolina
United States	University of Louisville	Louisville	Kentucky
United States	Vanderbilt University	Nashville	Tennessee
United States	Tulane University	New Orleans	Louisiana
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	UPMC	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Washington University at St. Louis	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Jason Sperry	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour survival		From injury through 24 hours
Secondary	Proportion of subjects that survive to hospital discharge		From hospital admission through death or hospital discharge up to 30 days
Secondary	Rate of first pass success of placement of advanced airway device		At time of placement of device through confirmation of device placement
Secondary	ICU length of stay		Admission through 30 days or discharge
Secondary	Ventilator days		Admission through 30 days or discharge
Secondary	Incidence of expected adverse events		From initial airway management through first 24 hours of hospital admission
Secondary	Incidence of need for rescue airway device		At the time of placement of device through time of arrival to trauma bay
Secondary	Incidence of hypoxia		At the time of placement of device through time of arrival to trauma bay
Secondary	Incidence of hypotension		At the time of placement of device through time of arrival to trauma bay