Functional Near-infrared Spectroscopy in Unconscious Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmanuela Keller

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • single-center prospective pilot study

    Other intervention

    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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Experimental (unconscious)Experimental treatment 1 intervention
Group B: Control group (healthy, conscious)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
7 days

Secondary outcomes

1

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.

Time frame
1 day

Other outcomes

1

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)

Time frame
7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emanuela Keller

Lead sponsor

University of Zurich

Sponsor institution