Clinical trial NCT04906252: Vfib by ECG or Echo During Cardiac Arrest
Official title: Ventricular Fibrillation and Electrocardiographic Rhythm vs Echocardiographic Rhythm During Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: Echocardiography
Ultrasound
Ventricular Fibrillation
Vfib
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Temple University
name: Stony Brook University
name: University of Ottawa
name: ChristianaCare
name: Boston Medical Center
name: Dartmouth College
name: University of Alabama at Birmingham
name: University of Rochester
name: Baystate Medical Center
name: Medical College of Wisconsin
name: University of Pennsylvania
name: Prisma Health-Midlands
name: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
name: Staten Island University Hospital
name: State University of New York - Upstate Medical University
name: University of Manitoba
name: Mayo Clinic
name: Kaweah Delta Health Care District
name: SBH Health System
name: Yale University
name: Johns Hopkins University
name: The University of Texas at San Antonio
name: Wake Forest University Health Sciences
name: University of Arkansas
name: Valleywise Health
name: Kendall Healthcare Group, Ltd.
name: Truman Medical Center
name: Oregon Health and Science University
name: Vassar Brothers Medical Center
name: Brookdale University Hospital Medical Center
name: University of Kansas Medical Center
name: University of Maine
name: University of Colorado, Denver
name: Duke University
name: University at Buffalo
name: North Shore University Hospital
name: Hartford Hospital
name: Louisiana State University Health Sciences Center in New Orleans
name: University of Florida
name: University of Maryland
name: Sutter Medical Foundation
name: Arizona School of Health Sciences
name: Virginia Commonwealth University
First posted: 2021-05-28
Enrollment: 813
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting after out of hospital cardiac arrest to the emergency department.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival to Hospital Admission
timeFrame: up to 60 minutes
measure: Rhythm Change post defibrillation
timeFrame: up to 60 minutes
Secondary outcomes:
measure: Return of Spontaneous Circulation (ROSC)
timeFrame: up to 60 minutes
measure: Survival to Hospital Discharge
timeFrame: up to discharge, on average 7 days
measure: Ventricular Fibrillation (VFib) detected via Ultrasound but not detected via Electrocardiogram (ECG)
timeFrame: up to 60 minutes
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Pittsburgh
country: United States
facility: Allegheny Hospital
state: Pennsylvania
city: San Antonio
country: United States
facility: Univesity of Texas San Antonio
state: Texas
Study officials:
affiliation: UMass Medical School
name: Romolo Gaspari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: