Using near-infrared spectroscopy to assess unconscious patients with severe strokes
Prognostic Value of Functional Near-infrared Spectroscopy in Unconscious Neurocritical Care Patients- a Prospective Pilot Study
NA · University of Zurich · NCT04746820
This study is testing a new tool called near-infrared spectroscopy to see if it can help doctors better understand the condition of unconscious patients with severe strokes in the ICU.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich (other) |
| Locations | 2 sites (Zurich, Canton of Zurich and 1 other locations) |
| Trial ID | NCT04746820 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the effectiveness of functional near-infrared spectroscopy (fNIRS) as a prognostic tool for unconscious patients suffering from severe hemorrhagic or ischemic strokes in the ICU. The study compares fNIRS results with established methods like somatosensory and auditory evoked potentials (SSEP and AEP) and electroencephalography (EEG) to determine their congruence. By focusing on unconscious patients after cardiac arrest, the study aims to enhance prognosis accuracy and improve patient management in neuro-intensive care settings. The research is conducted at a single center, the University Hospital Zurich.
Who should consider this trial
Good fit: Ideal candidates include unconscious adults aged 18 and older with severe hemorrhagic or ischemic strokes or hypoxic brain injury after cardiac arrest.
Not a fit: Patients under 18 years of age or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for early prognosis in unconscious stroke patients, aiding in better clinical decision-making and patient management.
How similar studies have performed: While evoked potentials are established prognostic tools, the use of fNIRS in this context is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zurich, Canton of Zurich and 1 other locations
- University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (RECRUITING)
- University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Emanuela Keller, Prof. Dr. — University Hospital, Zürich
- Study coordinator: Emanuela Keller, Prof. Dr.
- Email: emanuela.keller@usz.ch
- Phone: +41 44 255 56 71
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nervous System Diseases, Healthy Subjects, severe cerebral hemorrhage, ischemic stroke, unconscious neurocritical care patients, functional near-infrared spectroscopy, evoked potentials, electroencephalography