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First responder airway and compression rate cluster randomized controlled trial: rational and design
Thomas Rea1,2, Jenny Shin2, Jennifer Blackwood2
1University of Washington, Department of Medicine, United States.
Background:
The specific components of professional first-responder CPR (chest compressions and ventilations) are associated with clinical outcomes following out-of-hospital cardiac arrest (OHCA). Yet, this understanding about best-practices CPR is largely informed by observational rather than randomized evaluation. The First responder Airway and Compression rate Trial (FACT) will evaluate the survival effects of the professional first responder airway management and three compression rates.
Design And Setting:
FACT is a factorial, cluster-randomized, cross-over trial conducted in a large metropolitan region in the United States by Emergency Medical Services (EMS). Study interventions are allocated according to EMS agency every 4 months.
Study Subjects:
The study plans to enroll ∼4200 adults with nontraumatic OHCA treated by first responder firefighter emergency medical technicians (EMTs).
Interventions:
Randomized interventions will include the initial EMT airway (mask or i-gel supraglottic airway) and the professional rescuer compression rate (100 or 110 or 120 compressions per minute). Inspiratory and expiratory ventilation volume will be assessed in a subset of subjects. Compression rates will be directed by metronome and assessed through review of the defibrillator recording.
Outcomes:
The primary outcome is survival to hospital discharge; secondary outcomes include return of spontaneous circulation at the end of EMS care and survival with favorable neurological status classified as Cerebral Performance Category of 1 or 2 at hospital discharge.
Subgroup Analyses:
Planned subgroup analyses include intervention comparisons according to sex, initial rhythm, and BLS CPR strategy (30:2 and 10:1).
Inference:
Results of the FACT study may inform fundamental approaches to first responder CPR.Clinical Trial Registration: ClinicalTrials.org (NCT05969028).
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