First Responder Airway & Compression Rate Trial

Recruiting now · Not applicable

Conditions studied: Out-Of-Hospital Cardiac Arrest

In brief

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.

Key facts

Study ID

NCT05969028

Run by

University of Washington

People needed

4200

Starts

2024-02-07

Expected to finish

2029-03-01

Last updated by the study team

2024-06-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• King County EMS — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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