International Termination of Resuscitation Practices

Sponsor

University of Southern Denmark (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05029180

Collaborator

(none)

Enrollment

3.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Neither the international nor the interregional variation in survival following OHCA is fully understood, but may rely on multiple factors such as: organization of the Emergency Medical Service (EMS) system bystander cardiopulmonary resuscitation (CPR), the use of Automatic External Defibrillators (AED's), response time, and which subgroups are included as the denominator, (i.e. obvious dead, withholding of resuscitation). Variation in denominators provide an obstacle when comparing outcome between different EMS-systems. Studies have found that Utstein factors explained half of the variation in survival to hospital discharge among different EMS agencies highlighting the importance of further research.

Due to the high mortality rate of OHCA, the decision of withholding or withdrawing resuscitative efforts must be made frequently. We find that a description of the differences in initiation and termination of resuscitation of adult patients (>18 years of age), suffering from non-traumatic OHCA could add an important perspective on the impact of differences in EMS systems across the World regarding the outcome following OHCA.

Condition or Disease	Intervention/Treatment	Phase
Out-Of-Hospital Cardiac Arrest	Other: Termination of resuscitation

Detailed Description

Out-of-hospital cardiac arrest (OHCA) is a leading cause of death in the World. Substantial international differences in survival to hospital discharge has been reported; ranging from 3.1% to 20.4% worldwide, 0% to 18% in Europe, 0,5% to 8,5% in Asia, 9% to 17% in Australia and New Zealand and from 1.1% to 8.4% in North America. Regional differences of up to a fivefold increase in survival have also been reported in multiple settings and geographic locations.

Neither the international nor the interregional variation is fully understood, but may rely on multiple factors such as: organization of the Emergency Medical Service (EMS) system bystander cardiopulmonary resuscitation (CPR), the use of Automatic External Defibrillators (AED's), response time, and which subgroups are included as the denominator, (i.e. obvious dead, withholding of resuscitation). Variation in denominators provide an obstacle when comparing outcome between different EMS-systems. Studies have found that Utstein factors explained half of the variation in survival to hospital discharge among different EMS agencies highlighting the importance of further research.

Due to the high mortality rate of OHCA, the decision of withholding or withdrawing resuscitative efforts must be made frequently. The European Resuscitation Council (ERC) stated in their 2021 guidelines that:

"Systems should implement criteria for the withholding and termination of CPR out-of-hospital cardiac arrest (OHCA), taking into consideration the specific local legal, organizational, and cultural context."
"Systems should define criteria for the withholding and termination of CPR, and ensure criteria are validated locally."
"Systems should implement criteria for early transport to hospital in cases of OHCA, taking into account the local context, if there are no criteria for withholding/terminating CPR".

To validate Termination of Resuscitation rules locally could be challenging both ethically and epidemiologically. This would require a prospective study with a transportation rate of 100%, which could put an immense amount of pressure on the limited sources of the EMS system, and moreover providing sufficient power in the study could be difficult.

We find that a description of the differences in initiation and termination of resuscitation of adult patients (>18 years of age), suffering from non-traumatic OHCA could add an important perspective on the impact of differences in EMS systems across the World regarding the outcome following OHCA.

Study Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

International Termination of Resuscitation Practices - a Worldwide Survey

Anticipated Study Start Date :

May 16, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Outcome Measures

Primary Outcome Measures

Difference in termination of resuscitation practices - a questionnaire [1 year]
legislation, termination rules, cultural differences, regional differences, description

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Countries that provide two separate answers

Exclusion Criteria:

Countries that do not provide two separate answers

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Southern Denmark

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol - Apr 6, 2022

More Information

Publications

None provided.

Responsible Party:

Ulrik Havshøj, MD, PhD student, University of Southern Denmark

ClinicalTrials.gov Identifier:

NCT05029180

Other Study ID Numbers:

20/55990

First Posted:

Aug 31, 2021

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ulrik Havshøj, MD, PhD student, University of Southern Denmark

Termination of resuscitation

Additional relevant MeSH terms:

Out-of-Hospital Cardiac Arrest

Study Results

No Results Posted as of May 18, 2022