Comparing airway management methods for trauma patients before hospital arrival
Prehospital Airway Control Trial : A Randomized Controlled Trial of Prehospital Airway Management Strategy for Trauma Patients
NA · University of Pittsburgh · NCT04100564
This study is testing whether using a special airway device or standard methods helps trauma patients survive better before they reach the hospital.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2009 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 14 sites (Atlanta, Georgia and 13 other locations) |
| Trial ID | NCT04100564 on ClinicalTrials.gov |
What this trial studies
The Prehospital Airway Control Trial (PACT) is a multi-center trial that evaluates different airway management strategies for trauma patients in prehospital settings. Participants will be randomly assigned to receive either standard airway management or a supraglottic airway device during their initial airway attempt. The primary goal is to assess 24-hour survival rates, while secondary outcomes include survival to hospital discharge, adverse clinical events, and various metrics related to ICU care. The study aims to enroll approximately 2,009 subjects across 17 prehospital agencies over five years.
Who should consider this trial
Good fit: Ideal candidates are trauma patients with indicators necessitating advanced airway management, such as low GCS or inadequate oxygen saturation.
Not a fit: Patients under 15 years of age, those with known pregnancy, or those experiencing cardiac arrest without ROSC will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and outcomes for trauma patients requiring advanced airway management.
How similar studies have performed: Previous studies have shown varying success with different airway management techniques, but this specific approach is novel in the prehospital setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Atlanta, Georgia and 13 other locations
- Emory University — Atlanta, Georgia, United States (RECRUITING)
- Mount Sinai Hospital — Chicago, Illinois, United States (RECRUITING)
- Northwestern Memorial Hospital — Chicago, Illinois, United States (RECRUITING)
- John H. Stroger Hospital of Cook County — Chicago, Illinois, United States (RECRUITING)
- University of Chicago — Chicago, Illinois, United States (RECRUITING)
- University of Louisville — Louisville, Kentucky, United States (RECRUITING)
- Tulane University — New Orleans, Louisiana, United States (RECRUITING)
- Washington University at St. Louis — Saint Louis, Missouri, United States (COMPLETED)
- East Carolina University — Greenville, North Carolina, United States (RECRUITING)
- Oregon Health & Science University — Portland, Oregon, United States (RECRUITING)
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)
- UPMC — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Vanderbilt University — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Jason Sperry, MD, MPH — University of Pittsburgh
- Study coordinator: Jason Sperry, MD, MPH
- Email: sperryjl@upmc.edu
- Phone: 412 802 8270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Trauma Injury, Airway Control, intubation, supraglottic airway