First Responder Airway & Compression Rate Trial (FACT Study)

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Washington
King County EMS
RECRUITING
Seattle
Contact Information
Primary
Jenny B Shin
jennys2@uw.edu
206-263-8586
Time Frame
Start Date: 2024-02-07
Estimated Completion Date: 2029-03
Participants
Target number of participants: 4200
Treatments
Active_comparator: Airway Strategy
Each of 28 first responder EMS agencies in King County will be randomly assigned to treat with either the BVM or i-gel for airway strategy
Active_comparator: Compression Rate
Each of 28 first responder EMS agencies in King County will be randomly assigned with one of the three chest compression rates (100 vs 110 vs 120) at the outset.
Related Therapeutic Areas
Sponsors
Leads: University of Washington

This content was sourced from clinicaltrials.gov