Recruiting

Airway & Compression

Sponsor:

University of Washington

Code:

NCT05969028

Conditions

Out-Of-Hospital Cardiac Arrest

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

igel

Compression Rate

Study Details

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.

Conditions

Out-Of-Hospital Cardiac Arrest

Study ID

NCT05969028

Start date

Feb 7, 2024

Status verified date

Jun, 2024

Completion date

Mar, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

4200 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

igel

First responder ventilation strategy. First responders in King County routinely use the BVM as part of core treatment of SCA. As part of EMS training, we have introduced a training module for use of the igel in simulated resuscitation, which has been enthusiastically accepted by EMS leadership and providers. The i-gel is already successfully practiced by BLS providers in a number of other communities and challenges in training and clinical application will be monitored, but not anticipated.

Compression Rate

Compression rates. The EMS system routinely measures EMS CPR performance and specifically the chest compression rate using information derived and electronically recorded from defibrillator patches. As detailed in the Background section, this CPR surveillance activity highlights the variability of compression rates across the guideline-directed range of 100-120 compressions per minute. In addition our CPR surveillance indicates that a metronome can be used to obtain and maintain a specific compression rate within the parameters specified by this trial. This will be the tool used to guide compliance with the assigned chest compression rate by on-scene providers.

Primary outcome measure

  • Survival to Hospital Discharge [ Time Frame: This outcome typically occurs days to weeks after Cardiac Arrest Event. The study will monitor for this outcome for 6 months following the cardiac arrest event. ]

Central Contacts and Locations

Central contacts

Jenny B Shin

206-263-8586jennys2@uw.edu

Locations

King County EMS

Recruiting

Seattle, Washington, United States, 98104

Contacts

FACT Study Coordinator

206-263-8577factstudy@kingcounty.gov

More Information

Sponsor

University of Washington

Last update posted

Jun 13, 2024

Last verified

Jun, 2024

Keywords

  • Airway Management
  • CPR
  • Emergency Medical Services
  • Basic Life Support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2024-06-13.