Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
813 participants
OBSERVATIONAL
2021-09-15
2025-01-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Echocardiography
Patients presenting in cardiac arrest will undergo echocardiography as is the standard of care at their institution
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
Echocardiography
Patients presenting in cardiac arrest will undergo echocardiography as is the standard of care at their institution
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
Echocardiography
Patients presenting in cardiac arrest will undergo echocardiography as is the standard of care at their institution
Electrocardiogram (ECG)
Patients presenting in cardiac arrest will undergo an electrocardiogram (ECG) as is the standard of care at their institution
Interventions
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Echocardiography
Patients presenting in cardiac arrest will undergo echocardiography as is the standard of care at their institution
Electrocardiogram (ECG)
Patients presenting in cardiac arrest will undergo an electrocardiogram (ECG) as is the standard of care at their institution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Documented allergy to ultrasound gel
* Technical malfunction of ultrasound machine during imaging that prevents use Ultrasound machine unable to record images
18 Years
ALL
No
Sponsors
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Temple University
OTHER
Stony Brook University
OTHER
University of Ottawa
OTHER
ChristianaCare
OTHER
Boston Medical Center
OTHER
Dartmouth College
OTHER
University of Alabama at Birmingham
OTHER
University of Rochester
OTHER
Baystate Medical Center
OTHER
Medical College of Wisconsin
OTHER
University of Pennsylvania
OTHER
Prisma Health-Midlands
OTHER
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
OTHER
Staten Island University Hospital
OTHER
State University of New York - Upstate Medical University
OTHER
University of Manitoba
OTHER
Mayo Clinic
OTHER
Kaweah Delta Health Care District
OTHER
SBH Health System
OTHER
Yale University
OTHER
Johns Hopkins University
OTHER
The University of Texas at San Antonio
OTHER
Wake Forest University Health Sciences
OTHER
University of Arkansas
OTHER
Valleywise Health
OTHER
Kendall Healthcare Group, Ltd.
INDUSTRY
Truman Medical Center
OTHER
Oregon Health and Science University
OTHER
Vassar Brothers Medical Center
OTHER
Brookdale University Hospital Medical Center
OTHER
University of Kansas Medical Center
OTHER
University of Maine
OTHER
University of Colorado, Denver
OTHER
Duke University
OTHER
University at Buffalo
OTHER
North Shore University Hospital
OTHER
Hartford Hospital
OTHER
Louisiana State University Health Sciences Center in New Orleans
OTHER
University of Florida
OTHER
University of Maryland
OTHER
Sutter Medical Foundation
OTHER
Arizona School of Health Sciences
OTHER
Virginia Commonwealth University
OTHER
Romolo Gaspari
OTHER
Responsible Party
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Romolo Gaspari
Professor
Principal Investigators
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Romolo Gaspari, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMass Medical School
Locations
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Hartford Hospital
Hartford, Connecticut, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Stony Brook University
Stony Brook, New York, United States
Duke University
Durham, North Carolina, United States
Allegheny Hospital
Pittsburgh, Pennsylvania, United States
Univesity of Texas San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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H00021832
Identifier Type: -
Identifier Source: org_study_id
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