Clinical trial NCT05545176: The Validation and Development of Termination-of-Resuscitation (TOR) Rules in OHCA Patients in Asia Countries
Official title: The Validation and Development of Termination-of-Resuscitation (TOR) Rules in Patients Following Out-of-Hospital Cardiac Arrest (OHCA) in Asia Countries
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: Out-Of-Hospital Cardiac Arrest
OHCA
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Singapore Clinical Research Institute
First posted: 2022-09-19
Enrollment: 140000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: survival to hospital discharge
timeFrame: survival to 30-day hospitalisation
Secondary outcomes:
measure: Cerebral Performance Categories Scale (CPC)
timeFrame: CPC within 30-day hospitalisation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: National Taiwan University
name: Shu-Hsien Hsu, MPH
role: PRINCIPAL_INVESTIGATOR
References: