The Validation and Development of Termination-of-Resuscitation (TOR) Rules in OHCA Patients in Asia Countries

September 19, 2022 updated by: National Taiwan University Hospital

The Validation and Development of Termination-of-Resuscitation (TOR) Rules in Patients Following Out-of-Hospital Cardiac Arrest (OHCA) in Asia Countries

Objectives/Hypotheses

  1. Prehospital termination-of-resuscitation (TOR) rules were developed in North American and European sites. Whether they remained valid in different geographic, ethnic, and cultural background areas is still under debate.
  2. Differences in characteristics of out-of-hospital cardiac arrests (OHCAs) and configurations of emergency medical service (EMS) between the Western and Asian countries, including relatively lower rate of presenting shockable rhythm (i.e. ventricular fibrillation / ventricular tachycardia; VF/VT), lower rates of bystander CPR, less advanced life support (ALS) implementation, and less public access defibrillators, might create potential threats to the prediction accuracy of TOR rules.
  3. We aim to conduct a study to validate the performance of ever published TOR rules in Asian OHCA population, including non-traumatic, traumatic, and pediatric OHCA patients. Furthermore, assess the possible variables that may impact the performance of TOR rules.
  4. We also aim to develop new TOR rules based on PAROS registry for Asia population, focusing on non-traumatic, traumatic, and pediatric OHCA patients, respectively.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

140000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population included adults, OHCA patients since1 January 2007, identified from the PAROS registry. The PAROS data encompass 13 countries. The exclusion criteria include: (1) age <18 years, (2) non-EMS transport to the emergency department, (3) obvious signs of death (e.g. decapitation, rigor mortis, lividity, and decapitation) or having do-not-resuscitate (DNR) orders, and (4) missing data despite meeting the inclusion criteria.

Description

Inclusion Criteria:

  • out of hospital cardiac arrest (OHCA) patients

Exclusion Criteria:

  • age <18 years
  • non-EMS transport to the emergency department
  • obvious signs of death (e.g. decapitation, rigor mortis, lividity, and decapitation) or having do-not-resuscitate (DNR) orders
  • missing data despite meeting the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
out of hospital cardiac arrest patients in Asia countries
Other: termination of resuscitation rules
Use retrospective data to analyze the accuracy termination of resuscitation rules and further develope a termination of resuscitation rule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival to hospital discharge
Time Frame: survival to 30-day hospitalisation
survival to 30-day hospitalisation
survival to 30-day hospitalisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral Performance Categories Scale (CPC)
Time Frame: CPC within 30-day hospitalisation
CPC Scale 1~5, minimum value: 1; maximum value:5; lower score means greater outcome
CPC within 30-day hospitalisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Singapore Clinical Research Institute

Investigators

  • Principal Investigator: Shu-Hsien Hsu, MPH, National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2007

Primary Completion (Anticipated)

June 1, 2032

Study Completion (Anticipated)

December 31, 2032

Study Registration Dates

First Submitted

September 14, 2022

First Submitted That Met QC Criteria

September 14, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202206030RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

30 years

IPD Sharing Access Criteria

PAROS study members

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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