Recruiting

Functional Near Infrared Spectroscopy

Sponsor:

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

Code:

NCT05752981

Conditions

Stroke

Cerebral Oxygenation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

multichannel time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)

Study Details

Brief summary:

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.

Conditions

Stroke

Cerebral Oxygenation

Study ID

NCT05752981

Start date

May 16, 2023

Status verified date

Feb, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

tr-FNIRS neuromonitor

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.

Interventions

multichannel time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)

Participants will be monitored during surgery using the multichannel time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS). This study is observational in nature and no intervention will be applied based on the results of the tr-fNIRS device.

Primary outcome measure

  • Impact of intraoperative hemodynamic parameter on regional differences in cerebral oxygenation (ScO2) between brain regions during surgery [ Time Frame: Duration of surgical procedure ]

Central Contacts and Locations

Central contacts

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

More Information

Sponsor

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

Last update posted

Mar 1, 2024

Last verified

Feb, 2024

Keywords

  • neuromonitoring
  • cerebral oxygenation
  • stroke
  • anesthesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-03-01.