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RHAPSody: Diagnostic Utility of RUSH Following ROSC

NCT ID: NCT03409289

Last Updated: 2022-12-27

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-11-14

Brief Summary

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This will be a prospective observational study of adult primary cardiac arrest patients presenting to Shands Emergency Department following ROSC or actively in cardiac arrest with subsequent ROSC after treatment in the emergency department.

Detailed Description

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This will be a prospective observational study of adult primary cardiac arrest patients presenting to Shands Emergency Department following ROSC or actively in cardiac arrest with subsequent ROSC after treatment in the emergency department. The study will be a single center pilot study to evaluate the role of the extended RUSH exam in patients following cardiac arrest in order to potentially diagnose the cause of their arrest. No control group will be included in this study due to ethical concerns of withholding a potentially life-saving diagnostic test. Patients will be treated with ACLS per standard of care and resuscitation measures given. Within two hours of return of spontaneous circulation, the RUSH exam will be performed by ultrasound-trained emergency department physicians with images saved into the Qpath system, our already existing database where all emergency ultrasound exams - education and diagnostic - are stored currently. The physician who performed the exam will fill out a checklist with their interpretation and findings based on the elements included in the exam. The data collected will be stored in a RedCap database. Identifying data will be removed from the images and reviewed by two experienced ultrasonographers who will give separate interpretations, and inter-observer reliability will be examined. We will then correlate the interpretation with that of the physicians performing the exam. The elements of the RUSH exam that will be performed include focused evaluation of the heart, inferior vena cava, abdomen and aorta with the addition of evaluation for DVT and ocular ultrasound. The evaluation for DVT will be an abbreviated exam with one view of each of the bilateral femoral veins and popliteal veins. Techniques for performing the exam are based on the 2012 RUSH guidelines \[2\]. The data will undergo statistical analysis to determine if the data supported the initial hypotheses. Subjects will be contacted 30 days following the initial study for telephone follow-up and a CPC assessment for neurologic recovery will also be performed at that time.

Conditions

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Cardiac Arrest

Keywords

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Spontaneous Circulation (ROSC) Shock and Hypotension (RUSH) exam

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ROSC RUSH Exam

The study population will include out of hospital cardiac arrest (both traumatic and non-traumatic causes) with return of spontaneous circulation after the cardiac arrest while in the emergency department .

RUSH Exam

Intervention Type DEVICE

Within two hours of return of spontaneous circulation, the following elements of the RUSH exam will be performed: focused evaluation of the heart, inferior vena cava, abdomen and aorta with the addition of evaluation for DVT and ocular ultrasound.

Interventions

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RUSH Exam

Within two hours of return of spontaneous circulation, the following elements of the RUSH exam will be performed: focused evaluation of the heart, inferior vena cava, abdomen and aorta with the addition of evaluation for DVT and ocular ultrasound.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Incoming ER patients with return of spontaneous circulation after cardiac arrest

Exclusion Criteria

* Patients who do not achieve return of spontaneous circulation long enough for the exam to be performed
* Patients who have initial cardiac arrest while on an inpatient unit of the hospital
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leslie C. Nickels, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida Health (UFHealth)

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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OCR18537

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201702314

Identifier Type: -

Identifier Source: org_study_id