Out-Of-Hospital Cardiac ArrestNCT05029180
International Termination of Resuscitation Practices
An observational study of Out-Of-Hospital Cardiac Arrest, run by University of Southern Denmark.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Termination of resuscitation
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2022to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: International experts in OHCA
Who may be able to join
- Countries that provide two separate answers
Who cannot join
- Countries that do not provide two separate answers
About this study
Official title: International Termination of Resuscitation Practices - a Worldwide Survey
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.
Read the 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.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Termination of resuscitation
- Keywords
- Termination of resuscitation
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Termination of resuscitationOther
Do estimate the approaches used worldwide when terminating resuscitative efforts
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in termination of resuscitation practices - a questionnaire
legislation, termination rules, cultural differences, regional differences, description
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start16 May 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrik Havshøj, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029180
- Sponsor's protocol ID
- 20/55990
- Status last verified
- May 2022
- First submitted
- 11 Aug 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no data regarding patients in this study
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Termination of Resuscitation Practices - a Worldwide Survey
- ClinicalTrials.gov ID
- NCT05029180
- Acronym / sponsor ID
- 20/55990
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Keywords
- Termination of resuscitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 16 May 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 31 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- International experts in OHCA
Key inclusion criteria (1 listed)
- Countries that provide two separate answers
Key exclusion criteria (1 listed)
- Countries that do not provide two separate answers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Termination of resuscitationDo estimate the approaches used worldwide when terminating resuscitative efforts | Other | – |
Primary outcome
Difference in termination of resuscitation practices - a questionnaire
Time frame: 1 year
legislation, termination rules, cultural differences, regional differences, description
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No. There are no data regarding patients in this study
Related trials for Out-Of-Hospital Cardiac Arrest
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest, run by University of Southern Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in termination of resuscitation practices - a questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.