Monitoring brain oxygen levels during shoulder surgery to prevent stroke
Full-head Coverage Multi-channel Time-resolved Functional Near Infrared Spectroscopy for Early Detection and Prevention of Perioperative Brain Injury
This study is testing a new device to monitor brain oxygen levels in patients having shoulder surgery to see if it can help prevent strokes during the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT05752981 on ClinicalTrials.gov |
What this trial studies
This observational study aims to utilize a novel optical device called multi-channel time-resolved functional near infrared spectroscopy (tr-fNIRS) to monitor cerebral oxygenation and autoregulation in patients undergoing elective shoulder surgery. The focus is on detecting early signs of brain hypoperfusion, which can lead to covert strokes, a common complication in this surgical setting. By assessing regional differences in cerebral oxygenation during various physiological challenges, the study seeks to identify brain regions at higher risk for injury. The ultimate goal is to improve patient outcomes by enabling timely interventions to prevent brain injury during surgery.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older scheduled for elective shoulder surgery in the beach-chair position under general anesthesia.
Not a fit: Patients with skin or scalp lesions that prevent the application of the fNIRS device or those requiring emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of perioperative strokes and improve long-term cognitive outcomes for patients.
How similar studies have performed: Previous studies have shown promise in monitoring cerebral oxygenation during cardiac surgery, but this specific approach using tr-fNIRS in non-cardiac surgery is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (age ≥ 18 years old) * Scheduled to have elective shoulder surgery in the beach-chair position under general anesthesia * Provide informed consent Exclusion Criteria: i) have skin/scalp lesions that preclude the application of fNIRS device to the head ii) lack of written consent iii) emergency surgery
Where this trial is running
London, Ontario
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Jason Chui — Western University
- Study coordinator: Jason Chui
- Email: Jason.Chui@lhsc.on.ca
- Phone: 5196858500
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.