NCT04793386

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

April 6, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 14, 2021

Last Update Submit

April 5, 2021

Conditions

Cardiopulmonary Arrest

Outcome Measures

Primary Outcomes (1)

  • Time spent assessing

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

    Procedure (during chest compression)

Secondary Outcomes (1)

  • Agreement of return of spontaneous circulation

    Procedure (during chest compression)

Study Arms (1)

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.

Diagnostic Test: carotid ultrasound

Interventions

carotid ultrasoundDIAGNOSTIC_TEST

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

Carotid ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Interventions

Ultrasonography, Carotid Arteries

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Hee Yoon, Professor

    Samsung medical center, Emergency department

    STUDY CHAIR

Central Study Contacts

Sooyeon Kang, Fellow

CONTACT

+821031574718syrei3.kang@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2021

First Posted

March 11, 2021

Study Start

January 1, 2021

Primary Completion

December 1, 2021

Study Completion

March 1, 2022

Last Updated

April 6, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)