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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiopulmonary Arrest
• Intervention / Treatment: Diagnostic test: carotid ultrasound

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 Type: Interventional
• Enrollment (Anticipated): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sooyeon Kang, fellow; Phone Number: +821031574718; Email: syrei3.kang@samsung.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Sooyeon Kang, fellow; Phone Number: 82-10-3157-4718; Email: syrei3.kang@samsung.com
    • Contact: Hee Yoon, Professor; Phone Number: 82-10-9933-5581; Email: wildhi.yoon@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent assessing	Time spent assessing return of spontaneous circulation using two methods (manual pulse palpation and carotid ultrasound)	Procedure (during chest compression)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Study Chair: Hee Yoon, Professor, Samsung medical center, Emergency department

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: February 14, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: 2020-11-116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No