Cardiopulmonary ArrestNCT04793386
Usefulness of the Evaluation of the ROSC With Carotid Ultrasound During CPR
A study testing carotid ultrasound in people with Cardiopulmonary Arrest, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The current cardiopulmonary resuscitation(CPR) guidelines recommend that the heart rhythm be checked every two minutes during CPR for cardiac arrest patients. Also it is very important to stop compressing the chest in less than 10 seconds when checking heart rhythm and pulse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Arrest
- What is being tested?
- carotid ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2021to Mar 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patients who underwent CPR among cardiac arrest patients 18 years of age or older who visit the emergency room
- Patients who applied carotid ultrasound to determine the presence of carotid artery compression and pulse
Who cannot join
- Patients who have stated their intention to do not resuscitation for future treatment (including cardiopulmonary resuscitation)
- Patients who have difficulty applying carotid ultrasound due to head and neck trauma
- Patients who have difficulty applying carotid ultrasound due to deformed neck structure by surgery or head and neck cancer
- Return of spontaneous circulation before ultrasound application
- Patients who could not evaluate carotid artery compressibility and pulsatility by ultrasound
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Hee Yoon, Professor, 82-10-9933-5581, wildhi.yoon@samsung.com
Sooyeon Kang, fellow, 82-10-3157-4718, syrei3.kang@samsung.com
About this study
Official title: Usefulness of the Evaluation of the Return of Spontaneous Circulation(ROSC) With Carotid Ultrasound During Cardiopulmonary Resuscitation(CPR)
The current cardiopulmonary resuscitation(CPR) guidelines recommend that the heart rhythm be checked every two minutes during CPR for cardiac arrest patients. Also it is very important to stop compressing the chest in less than 10 seconds when checking heart rhythm and pulse.
However, manual palpation, which is used as a standard for return of spontaneous circulation(ROSC), has been reported that the accuracy is not high in several studies. It is quite often necessary to perform pulse palpation for longer than the 10 second recommended by the guidelines to make a judgment.
Recently, a case study was published in which the presence of spontaneous circulation was confirmed by evaluating the carotid artery compressibility and pulsatility with an ultrasound probe when checking the rhythm of cardiac arrest patients. However, there has been no clinical study on actual cardiac arrest patients.
Read the detailed description
The current cardiopulmonary resuscitation(CPR) guidelines recommend that the heart rhythm be checked every two minutes during CPR for cardiac arrest patients. Also it is very important to stop compressing the chest in less than 10 seconds when checking heart rhythm and pulse.
However, manual palpation, which is used as a standard for return of spontaneous circulation(ROSC), has been reported that the accuracy is not high in several studies. It is quite often necessary to perform pulse palpation for longer than the 10 second recommended by the guidelines to make a judgment.
Ultrasound is a key technique that guides to discern and treat causes of cardiac arrest patients. Recently, a case study was published in which the presence of spontaneous circulation was confirmed by evaluating the carotid artery compressibility and pulsatility with an ultrasound probe when checking the rhythm of cardiac arrest patients.
However, this is just a case study. There has been no clinical study on actual cardiac arrest patients whether it is possible to accurately determine the ROSC by evaluating the carotid artery compressibility and pulsatility by ultrasound. Also there has been no clinical studies on actual cardiac arrest patients comparing the time taken to evaluate the ROSC of carotid ultrasound and manual palpation.
- Conditions
- Cardiopulmonary Arrest
- Being tested
- carotid ultrasound
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid ultrasoundDiagnostic test
Every time checking pulse, evaluate the carotid artery compressibility and pulsatility by ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Carotid ultrasound | Experimental | When stopping chest compressions to check manual palpation every 2 minutes, an ultrasound scan of the carotid artery is performed. Whether or not return of spontaneous circulation is determined based on the compressibility and pulsatility of the carotid artery, and the time taken from the start of the ultrasound scan to the determination is recorded. Receives: Diagnostic Test: carotid ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent assessing
Time spent assessing return of spontaneous circulation using two methods (manual pulse palpation and carotid ultrasound)
Measured: Procedure (during chest compression)
Secondary outcomes (1)
Agreement of return of spontaneous circulation
Compare the agreement between two methods (manual pulse palpation and carotid ultrasound) for evaluation of return of spontaneous circulation (ROSC).
The gold standard is arterial blood pressure by arterial catheter. The ROSC is judged when pulsation is detected by manual palpation. The ROSC is judged when carotid artery is not totally compressed or has pulsatility by carotid artery ultrasound.
Measured: Procedure (during chest compression)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Jan 2021
- Primary completionDec 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ArrestStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee Yoon, Professor, Study chair, Samsung medical center, Emergency department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793386
- Sponsor's protocol ID
- 2020-11-116
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of the Evaluation of the Return of Spontaneous Circulation(ROSC) With Carotid Ultrasound During Cardiopulmonary Resuscitation(CPR)
- ClinicalTrials.gov ID
- NCT04793386
- Acronym / sponsor ID
- 2020-11-116
- Conditions
- Cardiopulmonary Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 11 Mar 2021 (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.
The current cardiopulmonary resuscitation(CPR) guidelines recommend that the heart rhythm be checked every two minutes during CPR for cardiac arrest patients. Also it is very important to stop compressing the chest in less than 10 seconds when checking heart rhythm and pulse.
However, manual palpation, which is used as a standard for return of spontaneous circulation(ROSC), has been reported that the accuracy is not high in several studies. It is quite often necessary to perform pulse palpation for longer than the 10 second recommended by the guidelines to make a judgment.
Recently, a case study was published in which the presence of spontaneous circulation was confirmed by evaluating the carotid artery compressibility and pulsatility with an ultrasound probe when checking the rhythm of cardiac arrest patients. However, there has been no clinical study on actual cardiac arrest patients.
Detailed description
The current cardiopulmonary resuscitation(CPR) guidelines recommend that the heart rhythm be checked every two minutes during CPR for cardiac arrest patients. Also it is very important to stop compressing the chest in less than 10 seconds when checking heart rhythm and pulse.
However, manual palpation, which is used as a standard for return of spontaneous circulation(ROSC), has been reported that the accuracy is not high in several studies. It is quite often necessary to perform pulse palpation for longer than the 10 second recommended by the guidelines to make a judgment.
Ultrasound is a key technique that guides to discern and treat causes of cardiac arrest patients. Recently, a case study was published in which the presence of spontaneous circulation was confirmed by evaluating the carotid artery compressibility and pulsatility with an ultrasound probe when checking the rhythm of cardiac arrest patients.
However, this is just a case study. There has been no clinical study on actual cardiac arrest patients whether it is possible to accurately determine the ROSC by evaluating the carotid artery compressibility and pulsatility by ultrasound. Also there has been no clinical studies on actual cardiac arrest patients comparing the time taken to evaluate the ROSC of carotid ultrasound and manual palpation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid ultrasound | Experimental | Diagnostic Test: carotid ultrasoundWhen stopping chest compressions to check manual palpation every 2 minutes, an ultrasound scan of the carotid artery is performed. Whether or not return of spontaneous circulation is determined based on the compressibility and pulsatility of the carotid artery, and the time taken from the start of the ultrasound scan to the determination is recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who underwent CPR among cardiac arrest patients 18 years of age or older who visit the emergency room
- Patients who applied carotid ultrasound to determine the presence of carotid artery compression and pulse
Key exclusion criteria (5 listed)
- Patients who have stated their intention to do not resuscitation for future treatment (including cardiopulmonary resuscitation)
- Patients who have difficulty applying carotid ultrasound due to head and neck trauma
- Patients who have difficulty applying carotid ultrasound due to deformed neck structure by surgery or head and neck cancer
- Return of spontaneous circulation before ultrasound application
- Patients who could not evaluate carotid artery compressibility and pulsatility by ultrasound
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 |
|---|---|---|
| carotid ultrasoundEvery time checking pulse, evaluate the carotid artery compressibility and pulsatility by ultrasound | Diagnostic test | Carotid ultrasound |
Primary outcome
Time spent assessing
Time frame: Procedure (during chest compression)
Time spent assessing return of spontaneous circulation using two methods (manual pulse palpation and carotid ultrasound)
1 secondary outcome
Agreement of return of spontaneous circulation
Time frame: Procedure (during chest compression)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Cardiopulmonary Arrest
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Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
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Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
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.
Hee Yoon, Professor study chair
Samsung medical center, Emergency department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carotid ultrasound in people with Cardiopulmonary Arrest, run by Samsung Medical Center at 1 site in South Korea.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Apr 2021. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sooyeon Kang, Fellow (+821031574718, syrei3.kang@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent assessing (time frame: Procedure (during chest compression)). 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 6 Apr 2021.