RHAPSody: Diagnostic Utility of RUSH Following ROSC

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03409289
• Other study ID #: IRB201702314
• Secondary ID: OCR18537
• Status: Terminated
• Start date: May 1, 2018
• Est. completion date: November 14, 2020

Study information

• Verified date: December 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 14, 2020
• Est. primary completion date: November 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

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.

Locations

Country	Name	City	State
United States	University of Florida Health (UFHealth)	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Time to ultimate diagnosis (if found)	Shorten length of time from presentation at ER to ultimate diagnosis.	length of hospital stay(7 days)