First Responder Airway & Compression Rate Trial (FACT)

June 11, 2024 updated by: Thomas Rea, University of Washington

First Responder Airway & Compression Rate Trial (FACT Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The First responder Airway & Compression rate Trial (FACT) Study will address basic life support (BLS) treatments administered by EMS first responders to patients who suffer a sudden circulatory (pulseless) collapse, referred to as sudden out-of-hospital cardiac arrest (SCA). The current standard of practice for first responder CPR includes chest compressions at a rate of 100-120 compressions per minute combined with rescue breathing using either a bag valve mask (BVM) or a type of oral airway called an i-gel. During rescue breathing with a BVM, a mask is attached to a breathing bag and placed over the patient's face. The BVM provides oxygen and clears carbon dioxide out of the lungs by blowing air through the patient's mouth. Alternatively, the i-gel consists of a short tube which is inserted in the back of the patient's throat. This tube blows oxygen more directly into the lungs, bypassing the mouth itself. Each of these breathing methods is considered standard of care treatment by EMS first responders. Standard of care means each method is commonly used to treat patients in cardiac arrest and is performed regularly, depending upon the community in which the cardiac arrest has occurred. The other component of CPR is chest compressions. The American Heart Association has recommended a chest compression rate during CPR of between 100-120 compressions per minute, but has not specified an ideal exact compression rate within this range. Scientific studies in both animals and clinical studies have shown that these different standard-of-care approaches to ventilation and the compression rate can produce different physiologic effects (such as the adequacy of rescue breathing and blood flow) that could impact clinical outcome. The investigators propose a randomized controlled trial among persons who suffer SCA to compare these two rescue breathing approaches 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.

Study Type

Interventional

Enrollment (Estimated)

4200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: 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.
Other Names:
  • airway management
  • Bag Valve Mask
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.
Procedure: 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.
Other Names:
  • CPR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return to Spontaneous Circulation (ROSC)
Time Frame: This outcome occurs within minutes of the cardiac arrest event. The outcome will be monitored for 1 day from the time of cardiac arrest.
This outcome provides a proximal outcome of the potential differential effectiveness of the study interventions.
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)
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.
This outcome will compare the proportion of subjects who survive to be discharged from the hospital who have favorable functional status as determined by the Cerebral Performance Category. This outcome is an endorsed outcome measure by the Utstein guidelines and a common secondary or 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Thomas Rea, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

May 19, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00014110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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