Cardiac ArrestNCT03409289
RHAPSody: Diagnostic Utility of RUSH Following ROSC
An observational study of Cardiac Arrest, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- RUSH Exam
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 14 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute care adult patients with cardiac arrest, including both traumatic and non-traumatic causes.
Who may be able to join
- Incoming ER patients with return of spontaneous circulation after cardiac arrest
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Health (UFHealth)
Gainesville, Florida, 32608
About this study
Official title: (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.
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.
- Conditions
- Cardiac Arrest
- Being tested
- RUSH Exam
- Keywords
- Spontaneous Circulation (ROSC), Shock and Hypotension (RUSH) exam
- Medical subject headings
- Heart Arrest, Shock, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUSH ExamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Device: RUSH Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: length of hospital stay (7 days)
Secondary outcomes (2)
Intervention or treatment initiated based on the results of the exam
Shorten time to critical interventions and/or treatment
Measured: length of hospital stay (7 days)
Time to ultimate diagnosis (if found)
Shorten length of time from presentation at ER to ultimate diagnosis.
Measured: length of hospital stay(7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start1 May 2018
- Primary completion14 Nov 2020
- Study completion14 Nov 2020
Why it stopped: Expired IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leslie C. Nickels, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409289
- Sponsor's protocol ID
- IRB201702314
- Other IDs
- OCR18537
- Status last verified
- Dec 2022
- First submitted
- 17 Jan 2018
- Last updated
- 27 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (RHAPSody) Diagnostic Utility of the Rapid Ultrasound for Shock and Hypotension (RUSH) Exam Following Return of Spontaneous Circulation (ROSC) in Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03409289
- Acronym / sponsor ID
- IRB201702314
- Conditions
- Cardiac Arrest
- Keywords
- Spontaneous Circulation (ROSC), Shock and Hypotension (RUSH) exam
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Expired IRB
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 14 Nov 2020 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ROSC RUSH Exam | – | Device: RUSH ExamThe 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 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute care adult patients with cardiac arrest, including both traumatic and non-traumatic causes.
Key inclusion criteria (1 listed)
- Incoming ER patients with return of spontaneous circulation after cardiac arrest
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RUSH ExamWithin 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. | Device | ROSC RUSH Exam |
Primary outcome
Cause of cardiac arrest.
Time frame: length of hospital stay (7 days)
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.
2 secondary outcomes
Intervention or treatment initiated based on the results of the exam
Time frame: length of hospital stay (7 days)
Time to ultimate diagnosis (if found)
Time frame: length of hospital stay(7 days)
Results and safety
The study was stopped early (reason given: Expired IRB). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie C. Nickels, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Expired IRB). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cause of cardiac arrest. (time frame: length of hospital stay (7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2022.