Clinical trial NCT04100564: LITES Task Order 0005 Prehospital Airway Control Trial (PACT)
Official title: Prehospital Airway Control Trial : A Randomized Controlled Trial of Prehospital Airway Management Strategy for Trauma Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trauma Injury
Airway Control
Keywords: intubation
supraglottic airway
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2019-09-24
Enrollment: 2009
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: 24-hour survival
timeFrame: From injury through 24 hours
Secondary outcomes:
measure: Proportion of subjects that survive to hospital discharge
timeFrame: From hospital admission through death or hospital discharge up to 30 days
measure: Rate of first pass success of placement of advanced airway device
timeFrame: At time of placement of device through confirmation of device placement
measure: ICU length of stay
timeFrame: Admission through 30 days or discharge
measure: Ventilator days
timeFrame: Admission through 30 days or discharge
measure: Incidence of expected adverse events
timeFrame: From initial airway management through first 24 hours of hospital admission
measure: Incidence of need for rescue airway device
timeFrame: At the time of placement of device through time of arrival to trauma bay
measure: Incidence of hypoxia
timeFrame: At the time of placement of device through time of arrival to trauma bay
measure: Incidence of hypotension
timeFrame: At the time of placement of device through time of arrival to trauma bay
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Mount Sinai Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: John H. Stroger Hospital of Cook County
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Saint Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: University of Pittsburgh
name: Jason Sperry, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Francis Guyette, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: