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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH- 16-D- 0024 | Other Grant/Funding Number | Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard airway method arm | Active Comparator | Standard airway management strategy |
|
| Supraglottic airway method arm | Experimental | Supraglottic first airway management strategy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supraglottic airway device | Device | Initial advanced airway management with a supraglottic device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour survival | From injury through 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects that survive to hospital discharge | From hospital admission through death or hospital discharge up to 30 days | |
| Rate of first pass success of placement of advanced airway device | At time of placement of device through confirmation of device placement |
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Inclusion Criteria:
Exclusion Criteria:
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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| Name | Affiliation | Role |
|---|---|---|
| Jason Sperry, MD, MPH | University of Pittsburgh | Principal Investigator |
| Francis Guyette, MD, MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30303 | United States | ||
| Mount Sinai Hospital |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2023 |
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Stepped-wedge
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| Standard airway management | Other | Initial advanced airway management with standard care method |
|
| ICU length of stay | Admission through 30 days or discharge |
| Ventilator days | Admission through 30 days or discharge |
| Incidence of expected adverse events | From initial airway management through first 24 hours of hospital admission |
| Incidence of need for rescue airway device | At the time of placement of device through time of arrival to trauma bay |
| Incidence of hypoxia | At the time of placement of device through time of arrival to trauma bay |
| Incidence of hypotension | At the time of placement of device through time of arrival to trauma bay |
| 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 |
| Apr 8, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 6, 2025 | Apr 8, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000081084 | Accidental Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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