About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Single group
Treatments tested in this trial
single-center prospective pilot study
Other interventionfNIRS 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
Treatment groups
Trial outcomes
Primary outcomes
Results of fNIRS examination to those of evoked potentials (presence or absence of response) in unconscious ICU patients with severe hemorrhagic, ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation.
Correlation of presence of typical relative changes in NIRS pattern (increase of oxygenated hemoglobin and decrease of deoxygenated haemoglobin) to positive response to somatosensory and auditory stimulation measured by electroencephalography (change of cortical electrical acivity after stimulation). Both signals will be either present or absent.
Secondary outcomes
Evaluation of the agreement of the results of the experimental group and the control group
Frequency of presence of typical relative changes in NIRS pattern (increase of oxygenated hemoglobin and decrease of deoxygenated haemoglobin) compared in healthy controls and patients.
Other outcomes
Safety endpoints (adverse events)
Incidence of adverse events (for evoked potentials: skin infection or bleeding at the puncture site of electrode needles; for fNIRS: local allergic reaction against plaster or burning of the skin)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Emanuela Keller
Lead sponsor
University of Zurich
Sponsor institution