First responder airway and compression rate cluster randomized controlled trial: rational and design.
Thomas Rea, Jenny Shin, Jennifer Blackwood...
https://pubmed.ncbi.nlm.nih.gov/42005615Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05969028
First Responder Airway & Compression Rate Trial (FACT Study)
Led by University of Washington · Updated on 2024-06-13
4200
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating basic life support treatments given by Emergency Medical Services (EMS) first responders to adults who experience sudden out-of-hospital cardiac arrest (SCA). The trial compares two rescue breathing methods: the standard Bag Valve Mask (BVM) and the i-gel device. It also studies different chest compression rates during CPR within the recommended range of 100 to 120 compressions per minute. Both treatments are currently used in standard care, and the study aims to see which approach may improve survival to hospital discharge. Participants will be treated by one of 28 EMS agencies randomly assigned to use either the BVM or the i-gel for airway management. These agencies will also be assigned to provide chest compressions at a set rate of either 100, 110, or 120 compressions per minute, guided by a metronome. The study compares these standard-of-care techniques to better understand their effects on patient outcomes. During the study, researchers will track participants from the time of cardiac arrest through hospital discharge, monitoring survival and neurological function. They will observe return of spontaneous circulation shortly after the event and follow survival and neurological status for up to six months. Data on chest compression rates will be electronically recorded to ensure adherence. The total duration of participation varies depending on hospital stay and recovery.
CONDITIONS
Brief Title
First Responder Airway & Compression Rate Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults suffering out-of-hospital non-traumatic sudden cardiac arrest in Seattle and greater King County
- Resuscitation attempted by first responding EMS personnel
You will not qualify if you...
- Advanced paramedic providers are first on scene and have already started advanced life support (ALS)
- Written advance directive indicating do not attempt resuscitation
- Traumatic arrest (blunt, penetrating, burn)
- Known prisoner
- Known pregnancy
- Pediatric patients
- Pre-existing tracheostomy
- Currently receiving mechanical ventilator support
- Presence of an "opt out" bracelet refusing clinical trial enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of resuscitation attempt during emergency response
Participants receive one of two standard rescue breathing methods (BVM or i-gel) along with chest compressions at a randomized rate of 100, 110, or 120 compressions per minute during CPR administered by EMS first responders.
Emergency treatment by first responders at the time of cardiac arrest
Follow-up
Duration - Up to 6 months
Participants are monitored for survival and neurological outcomes up to 6 months after the cardiac arrest event.
Approximately 1 to 2 follow-up assessments after hospital discharge
Trial Site Locations
Total: 1 location
1
King County EMS
Seattle, Washington, United States, 98104
Actively Recruiting
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Research Team
J
Jenny B Shin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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