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:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT04746820
Eligibility Criteria:
Inclusion Criteria - experimental group:
* Patients of either sex with severe hemorrhagic, ischemic stroke or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation treated at the Institute of Intensive Care Medicine, University Hospital Zurich
* Unconsciousness (GCS \< 9) or sedated to the severity of the disease (for the subgroup of patients included in the fNIRS-EEG measurement unconscious patients are defined as not responding to verbal stimuli. The motor response to pain should be one of the following: no response to pain / extensor response / flexor response / localize to pain)
* Age ≥ 18 years
* Signed informed consent obtained from legal representative
* Measurement logistically and technical possible within the first 7 days after admission
Inclusion Criteria - control group:
* Subjects of either sex
* Conscious (GCS = 15)
* Age ≥ 18 years
* Signed informed consent
Exclusion Criteria - experimental group:
* Patients age \< 18 years
* Positive pregnancy test for any female of childbearing potential or breast feeding female
* Previous auditory complaints or any ear diseases
* No response detectable at Erb's point in SSEP (e.g. due to peripheral nerve lesions, edema etc.)
* Any history of previous cerebral or brainstem disease
* Concomitant instable critical illness (e.g. sepsis, multi-organ failure, hemodynamic or respiratory instability)
* Acute status epilepticus
* Clinical recovery (GCS ≥ 9) or death before enrolment of the study
Exclusion Criteria - control group:
* Subjects age \< 18 years
* Positive pregnancy test for any female of childbearing potential or breast feeding female
* Previous auditory complaints or any ear diseases
* No response detectable at Erb's point in SSEP (e.g. due to peripheral nerve lesions, edema etc.)
* Any history of previous cerebral or brainstem disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04746820
Study Brief:
Protocol Section:
NCT04746820