Vfib by ECG or Echo During Cardiac Arrest (REASON3-2021)

Ventricular Fibrillation and Electrocardiographic Rhythm vs Echocardiographic Rhythm During Cardiac Arrest

The goal of this study is to measure survival rates associated with patients presenting in cardiac arrest based on their electrocardiographic rhythm and their echocardiographic rhythm. Electrocardiographic rhythm is defined as the rhythm on the ECG and echocardiographic rhythm is the rhythm visualized on bedside ultrasound. Specifically, we will categorize patients based on identical rhythms and dichotomous rhythms with an interest in outcomes in the patient group where their echocardiographic and electrographic rhythms do not match. This is important as current ACLS protocols use electrocardiographic rhythms to determine therapy but limited research implies that therapeutic decisions based on echocardiographic rhythm may produce increased survival.

This study will occur during emergency department resuscitation of patients presenting in cardiac arrest. Patients presenting to the emergency department after cardiac arrest will undergo standard resuscitation based on ACLS protocols. Ultrasound imaging will be performed as soon as possible after the patient arrives and digitally recorded, as is currently the standard of care at the institute. Simultaneous recording of the ECG rhythm strip will occur as well. This will be repeated for as many pauses in CPR as is warranted.

Each site will record data based on the Utstein nomenclature including patient demographics, arrest details and survival outcomes. Ultrasound images and ECG recordings will be de-identified and submitted to a central database. Data will be uploaded into a centralized database. Statistical analysis will analyze outcomes based on echocardiographic and sonographic findings. Our aim is to measure the survival benefit of treating out of hospital cardiac arrest using echocardiographic rhythm instead of electrocardiographic rhythm.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Diagnostic test: Echocardiography; Diagnostic test: Electrocardiogram (ECG)

Detailed Description

This is a multi-center, prospective, observational trial involving sites across the United States and Canada. Patients will be enrolled through the emergency department either presenting in cardiac arrest, or going into cardiac arrest while in the emergency department after having arrested out of hospital. Advanced Cardiac Life Support (ACLS) protocols and institutional policies for resuscitation will be followed, as is the current standard of care. A patient encounter will conclude upon halting of cardiopulmonary resuscitation. Patient outcome will be evaluated by chart review or follow-up.

Programs involved in this study must have already integrated echocardiography into Cardiac Arrest clinically and have established procedures for how imaging is performed in the context of CPR. Echocardiography will not hinder or impair resuscitative efforts in any way, including halting CPR or prolonging pauses in CPR. Sonographic images will be obtained during designated pauses in chest compressions, as is routine care, during CPR for pulse checks, rhythm checks, and necessary resuscitative procedures.

Echocardiography will be performed as appropriate to obtain diagnostic information for each particular patient during resuscitative efforts. Recording of the image loops will be performed during image acquisition according to standard technology availability and clinical protocols at each site. To facilitate image acquisition, the ultrasound probe may be placed in the epigastrium or parasternal region during CPR with the heart centered in the field of view, if it will not interfere with ongoing resuscitation. Recording of the images can begin immediately upon pauses of CPR using whatever means are available at the site. Sonographic images will be obtained by competent personnel with experience in bedside cardiac ultrasound. This information will be made available to the physician taking care of the patient.

Continuous ECG tracings are displayed during cardiac arrest, and for the purpose of this study recordings of these ECG tracings will need to be digitally recorded. These digital ECG 'rhythm strips" will be matched with contemporaneous recordings of the ultrasound images of the heart.

Subject data, with identifiers removed, will be uploaded into the REDcap web-based database. Data will be obtained from initial patient encounter, patient records, and EMS records when available.

Contemporaneous digital recordings of ultrasound images and ECG rhythm strips blinded to patient identifiers will be included in a centralized database. Echocardiographic images will be reviewed and interpreted by the central coordinating site blinded to patient information. ECG images will be reviewed and interpreted by the central coordinating site blinded to patient information.

Patient cohorts will be compared for the electrical activity by ECG and the myocardial activity by echo.

• Study Type: Observational
• Enrollment (Actual): 813

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 02747
      • Dartmouth Hitchcock Medical Center
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Hospital
  • Texas
    • San Antonio, Texas, United States, 78249
      • Univesity of Texas San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting after out of hospital cardiac arrest to the emergency department.

Description

Inclusion Criteria:

• Patients presenting in out-of-hospital, atraumatic cardiac arrest

Exclusion Criteria:

• Resuscitation ended due to end of life decisions
• Documented allergy to ultrasound gel
• Technical malfunction of ultrasound machine during imaging that prevents use Ultrasound machine unable to record images

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ventricular Fibrillation; Patients presenting to the Emergency Department after out of hospital cardiac arrest demonstrating Ventricular Fibrillation (Vfib) Cardiac Arrest or Patients demonstrating Vfib during cardiac arrest.	Diagnostic test: Echocardiography; Patients presenting in cardiac arrest will undergo echocardiography as is the standard of care at their institution; Other Names: Ultrasound; Diagnostic test: Electrocardiogram (ECG); Patients presenting in cardiac arrest will undergo an electrocardiogram (ECG) as is the standard of care at their institution
PEA; Patients presenting to the Emergency Department after out of hospital cardiac arrest demonstrating Pulseless Electrical Activity (PEA) Cardiac Arrest. Patients demonstrating PEA during cardiac arrest	Diagnostic test: Echocardiography; Patients presenting in cardiac arrest will undergo echocardiography as is the standard of care at their institution; Other Names: Ultrasound; Diagnostic test: Electrocardiogram (ECG); Patients presenting in cardiac arrest will undergo an electrocardiogram (ECG) as is the standard of care at their institution
Asystole Cardiac Arrest; Patients presenting to the Emergency Department after out of hospital cardiac arrest demonstrating Asystolic Cardiac Arrest. Patients demonstrating Asystole during cardiac arrest	Diagnostic test: Echocardiography; Patients presenting in cardiac arrest will undergo echocardiography as is the standard of care at their institution; Other Names: Ultrasound; Diagnostic test: Electrocardiogram (ECG); Patients presenting in cardiac arrest will undergo an electrocardiogram (ECG) as is the standard of care at their institution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival to Hospital Admission	Percentage of patients who survive at the point where they are admitted to the hospital	up to 60 minutes
Rhythm Change post defibrillation	Percentage of patients who when defibrillated have a change in their cardiac rhythm as reflected by Electrocardiogram (ECG) report	up to 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return of Spontaneous Circulation (ROSC)	Percentage of patients who demonstrate return of spontaneous circulation (ROSC)	up to 60 minutes
Survival to Hospital Discharge	Percentage of patients who survive at the point where they are discharged from the hospital	up to discharge, on average 7 days
Ventricular Fibrillation (VFib) detected via Ultrasound but not detected via Electrocardiogram (ECG)	The percentage of patients with Ventricular Fibrillation (VFib)which is detected via ultrasound examination but is not detected via Electrocardiogram (ECG)	up to 60 minutes

Collaborators and Investigators

• Sponsor: Romolo Gaspari
• Collaborators: Johns Hopkins University; University of Manitoba; University of Colorado, Denver; Mayo Clinic; University of Pennsylvania; Yale University; University of Maryland; University of Alabama at Birmingham; Stony Brook University; Duke University; University of Florida; Medical College of Wisconsin; Boston Medical Center; Wake Forest University Health Sciences; Oregon Health and Science University; State University of New York - Upstate Medical University; University of Kansas Medical Center; University at Buffalo; Temple University; University of Ottawa; Virginia Commonwealth University; University of Rochester; Dartmouth College; Louisiana State University Health Sciences Center in New Orleans; University of Arkansas; Prisma Health-Midlands; Hartford Hospital; Baystate Medical Center; North Shore University Hospital; Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute); Truman Medical Center; Valleywise Health; Staten Island University Hospital; The University of Texas at San Antonio; Brookdale University Hospital Medical Center; Kaweah Delta Health Care District; ChristianaCare; SBH Health System; Kendall Healthcare Group, Ltd.; Vassar Brothers Medical Center; University of Maine; Sutter Medical Foundation; Arizona School of Health Sciences
• Investigators: Principal Investigator: Romolo Gaspari, MD, PhD, UMass Medical School

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound; Echocardiography; Ventricular Fibrillation; Vfib
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Arrest; Ventricular Fibrillation
• Other Study ID Numbers: H00021832

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As a cardiac arrest study, there is not a current plan to share individual data but this may be reconsidered if required

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No