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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT03248557
Eligibility Criteria:
Inclusion Criteria:
* In or out-of-hospital cardiac arrest with ventricular fibrillation (VF) as first documented rhythm.
* A ≥3-second VF tracings before the first direct current (DC) shock.
* Signed informed consent. Patients unable to consent, it will be requested to an authorized relative.
* Study group: GCS ≤8 and subject to temperature management (hypothermia 32-34ºC or normothermia 36ºC).
* Control group: GCS=15, thus no indication for temperature management.
Exclusion Criteria:
* First documented rhythm other than VF (e.g. ventricular tachycardia, pulseless electrical activity, asystole)
* Unavailable or suboptimal quality of the ECG tracing before the first DC shock.
* Terminal disease or cognitive impairment before the SCD event.
* Other possible causes of comatose status different from SCD (e.g. drugs, traumatic brain injury, hypoxia).
* Aged under 18 .
* Unwilling to provide the informed consent.
* Comatose status (GCS≤8) and absence of temperature management or GCS ≥9 if temperature management was undertaken.
* Hemodynamic instability leading to incomplete 24 h of temperature management
* Early mortality and absence of subsequent withdrawal of sedation to assess cerebral performance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03248557
Study Brief:
Protocol Section:
NCT03248557