LITES Task Order 0005 Prehospital Airway Control Trial (PACT)

Launched by JASON SPERRY · Sep 20, 2019

Keywords

ClinConnect Summary

The Prehospital Airway Control Trial (PACT) is a research study that aims to compare different ways of managing the airway for patients with serious injuries before they reach the hospital. The trial will look at how effective these methods are in helping patients survive their injuries, especially within the first 24 hours after the injury occurs. Participants will either receive standard care or a specific airway management technique called a supraglottic airway approach. This study is expected to involve about 2,009 patients across 17 emergency medical service agencies over five years.

To be eligible for the trial, patients must be experiencing a traumatic injury that needs advanced airway support, such as having a low level of consciousness or difficulty breathing despite receiving oxygen. However, certain individuals will not be able to participate, including those under 15 years old or pregnant women. During the trial, emergency medical teams will assess the patient's condition and determine eligibility based on both observed symptoms and verbal reports from other medical personnel. Participants can expect to receive the best possible care during this critical time, and their health outcomes will be carefully monitored throughout the study.

Gender

ALL

Eligibility 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.