NCT04746820Completed
Functional Near-infrared Spectroscopy in Unconscious Patients
Prognostic Value of Functional Near-infrared Spectroscopy in Unconscious Neurocritical Care Patients- a Prospective Pilot Study
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
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 congruent with the results of SSEP and AEP. Hence, making it a potential prognostic tool for unconscious ICU patients. In a specific subgroup of unconscious patients after cardiac arrest and cardiopulmonary resuscitation the fNIRS measurement is congruent with the results of electroencephalography (EEG). The primary purpose of this study is to evaluate the agreement of the results of fNIRS examination to those of evoked potentials and EEG in unconscious ICU patients with severe hemorrhagic, or ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation. fNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects. To compare fNIRS with evoked potentials there are two test phases: 1. The cerebral response to a somatosensory stimulus (peripheral nerve stimulation) is measured by fNIRS and SSEP 2. The cerebral response to an auditory stimulus is measured by fNIRS and AEP To avoid biases the following has to be considered: * The timing of the measurements plays an important role. A time difference between compared measurements can influence the outcome significantly due to deterioration or recovery of the neuronal network during the time gap. Therefore, fNIRS and evoked potentials will be measured simultaneously. * If the compared measurement methods are conducted by the same researcher the possibility of bias is high. Hence, two different researcher will conduct each one measurement without knowing the results of each other during the measurement.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 12 Nov 2020
- Start date
- Jan 2020
- Primary completion date
- Oct 2026
- Lead sponsor
- Emanuela Keller
- Diseases
- Stroke
- NCT number
- NCT04746820
What you commit to
- Study type: Interventional
- Participants enrolled: 38
- From Jan 2020 to the primary completion date, Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous auditory complaints or any ear diseases
- Any history of previous cerebral or brainstem disease
- Concomitant instable critical illness (e.g. sepsis, multi-organ failure, hemodynamic or respiratory instability)
- Previous auditory complaints or any ear diseases
- Any history of previous cerebral or brainstem disease
Age
- Patients age \< 18 years
- Subjects age \< 18 years
Other
- Positive pregnancy test for any female of childbearing potential or breast feeding female
- No response detectable at Erb's point in SSEP (e.g. due to peripheral nerve lesions, edema etc.)
- Acute status epilepticus
- Clinical recovery (GCS ≥ 9) or death before enrolment of the study
- Positive pregnancy test for any female of childbearing potential or breast feeding female
- No response detectable at Erb's point in SSEP (e.g. due to peripheral nerve lesions, edema etc.)
Who the study is looking for
- 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
- Subjects of either sex
- Conscious (GCS = 15)
- Age ≥ 18 years
- Signed informed consent
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Zurich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.