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NCT05545176 Clinical Trial

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

Out-Of-Hospital Cardiac Arrest Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05545176
Other study ID # 202206030RINC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2007
Est. completion date December 31, 2032

Study information
Verified date July 2022
Source National Taiwan University Hospital
Contact Shu-Hsien Hsu, MPH
Email pedroe929@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 140000
Est. completion date December 31, 2032
Est. primary completion date June 1, 2032
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• termination of resuscitation rules
Use retrospective data to analyze the accuracy termination of resuscitation rules and further develope a termination of resuscitation rule.

Locations
Country Name City State
Taiwan National Taiwan University Taipei

Sponsors (2)
Lead Sponsor Collaborator
National Taiwan University Hospital Singapore Clinical Research Institute

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary survival to hospital discharge survival to 30-day hospitalisation survival to 30-day hospitalisation
Secondary Cerebral Performance Categories Scale (CPC) CPC Scale 1~5, minimum value: 1; maximum value:5; lower score means greater outcome CPC within 30-day hospitalisation
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