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| Name | Class |
|---|---|
| Temple University | OTHER |
| Stony Brook University | OTHER |
| University of Ottawa | OTHER |
| ChristianaCare |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiography | Diagnostic Test | Patients presenting in cardiac arrest will undergo echocardiography as is the standard of care at their institution |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting after out of hospital cardiac arrest to the emergency department.
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| Name | Affiliation | Role |
|---|---|---|
| Romolo Gaspari, MD, PhD | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06106 | United States | ||
| Dartmouth Hitchcock Medical Center |
As a cardiac arrest study, there is not a current plan to share individual data but this may be reconsidered if required
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| D014463 | Ultrasonography |
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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 |
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|
| Electrocardiogram (ECG) | Diagnostic Test | Patients presenting in cardiac arrest will undergo an electrocardiogram (ECG) as is the standard of care at their institution |
|
| 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 |
| Lebanon |
| New Hampshire |
| 02747 |
| United States |
| Stony Brook University | Stony Brook | New York | 11794 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Allegheny Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Univesity of Texas San Antonio | San Antonio | Texas | 78249 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D004568 | Electrodiagnosis |