First Responder Airway & Compression Rate Trial

NCT05969028 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00014110
• Study Type: interventional
• Target: 4,200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Survival to Hospital Discharge

  The outcome will compare the proportion of subjects who survive to be discharged from the hospital. The outcome is an endorsed outcome by the Utstein guidelines and a common primary outcome in clinical resuscitation studies.

  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.

Secondary Outcomes (2)

• Return to Spontaneous Circulation (ROSC)

  This outcome occurs within minutes of the cardiac arrest event. The outcome will be monitored for 1 day from the time of cardiac arrest.

• Survival with favorable neurological function (CPC 1-2)

  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.

Study Arms (2)

Airway Strategy

ACTIVE COMPARATOR

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

Device: igel

Compression Rate

ACTIVE COMPARATOR

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.

Procedure: Compression Rate

Interventions

igel DEVICE

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.

Also known as: airway management, Bag Valve Mask

Airway Strategy

Compression Rate PROCEDURE

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.

Also known as: CPR

Compression Rate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

King County EMS

Seattle, Washington, 98104, United States

RECRUITING

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Interventions

Airway Management; Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Resuscitation; Emergency Treatment

Study Officials

• Thomas Rea, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny B Shin

CONTACT

206-263-8586; jennys2@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Model Details: We propose a factorial-design, cluster randomized controlled trial. In brief, this means that two interventions (the type of rescue breathing treatment and chest compression rate) will be studied in the same patient; and that randomizing patients to these treatments will switch over various time periods between groups of fire departments in King County. That is, some fire departments will be performing BVM with a compression rate of 100 compressions per minute over a specified time period, and will thereafter switch to the i-gel and a different chest compression rate for a specified time period.

Study Record Dates

• First Submitted: May 19, 2023
• First Posted: August 1, 2023
• Study Start: February 7, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

US (1)