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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04793386
Other study ID # 2020-11-116
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date March 2022

Study information

Verified date February 2021
Source Samsung Medical Center
Contact Sooyeon Kang, Fellow
Phone +821031574718
Email syrei3.kang@samsung.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 23
Est. completion date March 2022
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
carotid ultrasound
Every time checking pulse, evaluate the carotid artery compressibility and pulsatility by ultrasound

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time spent assessing Time spent assessing return of spontaneous circulation using two methods (manual pulse palpation and carotid ultrasound) Procedure (during chest compression)
Secondary 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.
Procedure (during chest compression)
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