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TerminatedNCT03409289Updated Dec 27, 2022

RHAPSody: Diagnostic Utility of RUSH Following ROSC

An observational study in Cardiac Arrest, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-27.

Sponsored by University of Florida · Observational

Why this study was terminated
Expired IRB
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiac Arrest

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Keywords

  • Spontaneous Circulation (ROSC)
  • Shock and Hypotension (RUSH) exam
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceRUSH 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.

05

What researchers measure

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.

    Time frame: length of hospital stay (7 days)

Secondary outcomes

  1. Intervention or treatment initiated based on the results of the exam

    Shorten time to critical interventions and/or treatment

    Time frame: length of hospital stay (7 days)

  2. Time to ultimate diagnosis (if found)

    Shorten length of time from presentation at ER to ultimate diagnosis.

    Time frame: length of hospital stay(7 days)

06

Study locations

1 site
  • University of Florida Health (UFHealth)
    Gainesville, Florida 32608, United States
07

Registry details

Key details

Study ID
NCT03409289
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
May 1, 2018
Primary completion
Nov 14, 2020
Completion
Nov 14, 2020
Last update
Dec 27, 2022

Study contacts

Leslie C. Nickels, MD
principal investigator · University of Florida

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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