NCT06012838

Brief Summary

The cause of cardiac arrest mostly determines outcomes of cardiac arrest survivors. Identifying and treating the cause of cardiac arrest constitute a critical part in post-arrest care. However, the pathophysiology of cardiac arrest often encompasses multiple organ systems. Thus, forming accurate diagnosis for each case presents a daunting challenge, especially for unexperienced physicians. This study aims to evaluate whether a standardized protocol would improve the diagnostic proficiency for out-of-hospital cardiac arrest (OHCA) patients. Sixteen Emergency Medicine Residents from National Taiwan University Hospital participated in this study. The cause classification of OHCA (CCCA) protocol was developed by an expert cardiac arrest committee, and a lecture concerning the Utstein's template, the epidemiology of cardiac arrest and the CCCA protocol was addressed. Pre-/post-lecture questionnaires regarding self-assessed diagnostic certainty and knowledge of cardiac arrest were obtained and compared to evaluate participants' learning effectiveness. To validate the efficiency of protocol, medical records of 586 non-traumatic OHCA adults with successful resuscitation and ICU admission were reviewed retrospectively, and the OHCA cause of each patient was identified by the trained residents following CCCA protocol. The primary outcome was the diagnostic consistency between protocolized diagnosis, expert diagnosis and the discharge diagnosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 10, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 8, 2023

Last Update Submit

August 23, 2023

Conditions

Keywords

Non-traumatic Out-Of-Hospital Cardiac Arresttraining program

Outcome Measures

Primary Outcomes (2)

  • diagnostic consistency between protocolized diagnosis and the discharge diagnosis

    The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.

    3 months

  • diagnostic consistency between protocolized diagnosis and the expert diagnosis

    The diagnosis made by young physicians with protocol defined as protocolized diagnosis. Expert diagnosis was recognized as diagnosis identified by expert physician. The expert physician is an experienced emergency physicians specialized in both emergency and critical care, who has reviewed the medical records without the assistance of the established CCCA protocol. The discharge diagnosis is the major diagnosis related to index cardiac arrest. The Light's kappa was used to evaluate the consistency of OHCA classification.

    3 months

Secondary Outcomes (3)

  • Portion of sufficient confidence to make proper OHCA cause identification

    2 months

  • the accuracy rates on the classification test of OHCA cause before and after the lecture

    baseline, 2 weeks

  • diagnostic consistency between participants before and after the lecture

    baseline, 2 weeks

Study Arms (1)

cause classification of OHCA protocol

EXPERIMENTAL

The cause classification of OHCA protocol was developed by an expert cardiac arrest committee. A lecture concerning the Utstein's template, the epidemiology of cardiac arrest and the CCCA protocol was addressed to the participants.

Behavioral: Cause classification of OHCA protocol

Interventions

training program with cause classification of OHCA protocol

cause classification of OHCA protocol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Residents of National Taiwan University Hospital

You may not qualify if:

  • Visiting staffs of National Taiwan University Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei County, 100, Taiwan

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Min-Shan Tsai, MD, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

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

August 8, 2023

First Posted

August 28, 2023

Study Start

August 10, 2022

Primary Completion

November 10, 2022

Study Completion

November 10, 2022

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations