RHAPSody: Diagnostic Utility of RUSH Following ROSC

NCT03409289 | Terminated FDA Device

• 2 other identifiers: IRB201702314OCR18537
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Arrest

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intervention or treatment initiated based on the results of the exam

  length of hospital stay (7 days)

• Time to ultimate diagnosis (if found)

  length of hospital stay(7 days)

Study Arms (1)

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

Interventions

RUSH Exam 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.

ROSC RUSH Exam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Health (UFHealth)

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Heart Arrest; Shock; Hypotension

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Leslie C. Nickels, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 24, 2018
• Study Start: May 1, 2018
• Primary Completion: November 14, 2020
• Study Completion: November 14, 2020
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

US (1)