Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT03835403
Eligibility Criteria:
Inclusion Criteria:
* All out-of-hospital cardiac arrests recognized by Emergency Medical Dispatcher and where the HeartRunner system is activated.
* Non-traumatic etiology, this excludes intoxication, drowning or suicide.
* Age \> 7 years
Exclusion Criteria:
* Caller is not in direct contact with the patient
* If Emergency Medical Dispatcher deems AED is not indicated, e.g., in nursing homes where trained personal is present.
* OHCAs not treated by the EMS due to ethical reasons or obvious signs of death
* OHCAs with no heart runners within 1800 meters
* Not true cardiac arrest (suspected, but not verified)
* EMS-witnessed OHCAs
Emergency medical dispatchers are instructed not to activate heart runners in case any of the exclusion criteria above. However, since it can be challenging for emergency medical dispatchers to gather sufficient information about the patient within the first few minutes, heart runners will admittedly be activated even though they should not have been. Since randomization will occur for all cases in which a heart runner is activated, cases with any of the exclusion criteria will be secondarily excluded.
These cases will be accounted for but not included in analyses of outcome. Our pilot study showed approximately 60% of suspected cardiac arrests were true cardiac arrests. Therefore, we expect 40% of cases for which heart runners were dispatched not to be true cardiac arrests.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT03835403
Study Brief:
Protocol Section:
NCT03835403