Status:
RECRUITING
Functional Near-infrared Spectroscopy in Unconscious Patients
Lead Sponsor:
Emanuela Keller
Conditions:
Nervous System Diseases
Healthy Subjects
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study design is a single-center prospective pilot study. Hypothesis: Results of cerebral fNIRS examination in unconscious patients with severe hemorrhagic or ischemic stroke in the ICU are congrue...
Detailed Description
Severe ischemic and hemorrhagic stroke, as well cardiac arrest even after successful cardiopulmonary reanimation are great causes of morbidity and mortality in Europe and worldwide. Although preventio...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04746820
Start Date
January 15 2020
End Date
December 31 2026
Last Update
May 16 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, CH-8091
2
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, CH-8091