Usefulness of the Evaluation of the ROSC With Carotid Ultrasound During CPR

Sponsor
Samsung Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04793386
Collaborator
(none)
23
1
1
13.9
1.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: carotid ultrasound
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Usefulness of the Evaluation of the Return of Spontaneous Circulation(ROSC) With Carotid Ultrasound During Cardiopulmonary Resuscitation(CPR)
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Carotid ultrasound

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.

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

Outcome Measures

Primary Outcome Measures

  1. Time spent assessing [Procedure (during chest compression)]

    Time spent assessing return of spontaneous circulation using two methods (manual pulse palpation and carotid ultrasound)

Secondary Outcome Measures

  1. Agreement of return of spontaneous circulation [Procedure (during chest compression)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 06351

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

  • Study Chair: Hee Yoon, Professor, Samsung medical center, Emergency department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT04793386
Other Study ID Numbers:
  • 2020-11-116
First Posted:
Mar 11, 2021
Last Update Posted:
Apr 6, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2021