Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05029180 |
| Other study ID # |
20/55990 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 16, 2022 |
| Est. completion date |
September 1, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
University of Southern Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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:
1. "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."
2. "Systems should define criteria for the withholding and termination of CPR, and ensure
criteria are validated locally."
3. "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.
