Multi-channel Time-resolved Functional Near Infrared Spectroscopy for Prevention of Perioperative Brain Injury

Overseen By Jason Chui

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Disqualifiers: Skin lesions, Emergency surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of surgical procedure

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Covert stroke occurs in one out of fourteen patients during or shortly after surgery, and may result in long-term disability. Fortunately, stroke that occurs during non-cardiac surgery is most commonly caused by inadequate blood flow to the brain and is, therefore, preventable if it can be detected early. Current clinical tools used to monitor the brain during surgery do not have the accuracy nor the spatial coverage - they only monitor one small region of the brain. In this study, the investigators plan to apply a cutting-edge optical device, tr-fNIRS, to monitor the whole brain during shoulder surgery. The primary aim is to determine any regional differences in cerebral oxygenation (ScO2) and cerebral autoregulation (CA)between brain regions during surgery and especially during various physiological challenges, such as hypotension. The investigators hypothesize that certain brain regions are more likely to develop cerebral desaturation and impaired CA, and are more prone to brain injury than the frontal lobe region which is the traditional monitoring site. The investigators also hypothesize that cerebral desaturation (or hypoxic injury) events correlate with adverse postoperative neurological outcomes such as covert stroke, overt stroke and/or postoperative delirium.

Who Is on the Research Team?

Jason Chui

Principal Investigator

Western University

Are You a Good Fit for This Trial?

Inclusion Criteria

Scheduled to have elective shoulder surgery in the beach-chair position under general anesthesia

Provide informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

tr-fNIRS is used to monitor regional brain oxygenation from anesthesia induction to completion of surgery

Duration of surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of covert stroke and neurological deficits

Up to 72 hours following surgery or until discharge from hospital

What Are the Treatments Tested in This Trial?

Interventions

• Multi-channel Time-resolved Functional Near Infrared Spectroscopy

How Is the Trial Designed?

Group I: tr-FNIRS neuromonitor Experimental Treatment 1 Intervention

During shoulder surgery, the tr-fNIRS (time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)) neuromonitor will be used to gather data on cerebral oxygenation of multiple brain regions for these patients. No intervention will be administered based on the results of the tr-fNIRS.

Who Is Running the Clinical Trial?

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+