NCT05969028 First Responder Airway & Compression Rate Trial
| NCT ID | NCT05969028 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Out-Of-Hospital Cardiac Arrest |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,200 participants |
| Start Date | 2024-02-07 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,200 participants in total. It began in 2024-02-07 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The First responder Airway \& Compression rate Trial (FACT) Study will address basic life support (BLS) treatments administered by Emergency Medical Services (EMS) first responders to patients who suffer a sudden circulatory (pulseless) collapse, referred to as sudden out-of-hospital cardiac arrest (SCA). The investigators propose a randomized controlled trial among persons who suffer SCA to compare these two rescue breathing approaches (standard Bag Valve Mask vs i-gel) along with evaluating a more precise chest compression rate within the range of 100-120 compressions per minute during CPR. Importantly, each of these treatments fall within established resuscitation guidelines and are already administered as part of standard care in clinical practice. Thus this proposed trial will essentially be comparing one standard-of-care treatment against another standard-of-care treatment. The study will address two primary aims: Aim 1: To compare survival to hospital discharge between SCA patients randomized to BVM versus the i-gel for rescue breathing. The hypothesis is that treatment with i-gel will result in a higher rate of survival to hospital discharge than BVM. Aim 2: To compare survival to hospital discharge between SCA patients randomized to chest compression rates of 100 versus 110 versus 120 per minute. The hypothesis is that treatment with 100 chest compressions per minute will result in a higher rate of survival to hospital discharge than compression rates of 110 or 120 per minute.
Eligibility Criteria
Inclusion Criteria: * Adults suffering out-of-hospital non-traumatic SCA in Seattle and greater King County in whom resuscitation will be attempted by first responding EMS personnel. Exclusion Criteria: * if advanced paramedic providers are first on-scene and have already initiated advanced life support (ALS) procedures, * a written advance directive (do not attempt resuscitation orders), * traumatic arrest (blunt, penetrating, burn), * known prisoner, * known pregnancy, * other protected populations (pediatrics), * pre-existing tracheostomy, * recipients of mechanical ventilator support, or * presence of an "opt out" bracelet to not be enrolled in clinical trials.
Contact & Investigator
Thomas Rea, MD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05969028 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Out-Of-Hospital Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05969028 currently recruiting?
Yes, NCT05969028 is actively recruiting participants. Contact the research team at jennys2@uw.edu for enrollment information.
Where is the NCT05969028 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT05969028 clinical trial?
NCT05969028 is sponsored by University of Washington. The principal investigator is Thomas Rea, MD at University of Washington. The trial plans to enroll 4,200 participants.