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

Primary Purpose

Cardiopulmonary Arrest

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
carotid ultrasound
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiopulmonary Arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carotid ultrasound

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
February 14, 2021
Last Updated
April 5, 2021
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04793386
Brief Title
Usefulness of the Evaluation of the ROSC With Carotid Ultrasound During CPR
Official Title
Usefulness of the Evaluation of the Return of Spontaneous Circulation(ROSC) With Carotid Ultrasound During Cardiopulmonary Resuscitation(CPR)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Arrest

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carotid ultrasound
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
carotid ultrasound
Intervention Description
Every time checking pulse, evaluate the carotid artery compressibility and pulsatility by ultrasound
Primary Outcome Measure Information:
Title
Time spent assessing
Description
Time spent assessing return of spontaneous circulation using two methods (manual pulse palpation and carotid ultrasound)
Time Frame
Procedure (during chest compression)
Secondary Outcome Measure Information:
Title
Agreement of return of spontaneous circulation
Description
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.
Time Frame
Procedure (during chest compression)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sooyeon Kang, Fellow
Phone
+821031574718
Email
syrei3.kang@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Yoon, Professor
Organizational Affiliation
Samsung medical center, Emergency department
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Yoon, Professor
Phone
82-10-9933-5581
Email
wildhi.yoon@samsung.com
First Name & Middle Initial & Last Name & Degree
Sooyeon Kang, fellow
Phone
82-10-3157-4718
Email
syrei3.kang@samsung.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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