Functional Near-infrared Spectroscopy in Unconscious Patients

Launched by EMANUELA KELLER · Feb 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new method called functional near-infrared spectroscopy (fNIRS) to see how well it can assess brain activity in patients who are unconscious due to severe strokes or cardiac arrest. The goal is to find out if the results from fNIRS are similar to those obtained from other established tests that measure brain function, such as somatosensory evoked potentials (SSEP) and auditory evoked potentials (AEP). This could help doctors better understand the condition of unconscious patients in the intensive care unit (ICU) and potentially predict their recovery.

To participate in this study, patients must be at least 18 years old and currently unconscious due to a severe stroke or brain injury. They will need consent from a legal representative. Healthy individuals who are conscious can also join as a control group. Participants can expect to undergo some non-invasive tests that measure their brain's response to different stimuli, such as touch and sound, while ensuring that the tests are conducted fairly and accurately. This research is an important step in improving care for patients who are critically ill and may benefit from better tools to assess their brain function.

Gender

ALL

Eligibility 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