RHAPSody: Diagnostic Utility of RUSH Following ROSC

(RHAPSody) Diagnostic Utility of the Rapid Ultrasound for Shock and Hypotension (RUSH) Exam Following Return of Spontaneous Circulation (ROSC) in Cardiac Arrest

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.

Study Overview

• Status: Terminated
• Conditions: Cardiac Arrest
• Intervention / Treatment: Device: RUSH Exam

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida Health (UFHealth)

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Acute care adult patients with cardiac arrest, including both traumatic and non-traumatic causes.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 .	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cause of cardiac arrest.	Assessment of a contributing diagnosis or cause of cardiac arrest following performance of the extended RUSH exam. We will examine if a diagnosis is provided or supported by the RUSH exam and if this leads to intervention.	length of hospital stay (7 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention or treatment initiated based on the results of the exam	Shorten time to critical interventions and/or treatment	length of hospital stay (7 days)
Time to ultimate diagnosis (if found)	Shorten length of time from presentation at ER to ultimate diagnosis.	length of hospital stay(7 days)

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Leslie C. Nickels, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): November 14, 2020
• Study Completion (Actual): November 14, 2020

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: January 17, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 27, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Spontaneous Circulation (ROSC); Shock and Hypotension (RUSH) exam
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: IRB201702314; OCR18537 (Other Identifier: University of Florida)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes