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

NCT05752981 | Recruiting

• 1 other identifier: tr-fNIRS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

neuromonitoring; cerebral oxygenation; stroke; anesthesia

Outcome Measures

Primary Outcomes (1)

• Impact of intraoperative hemodynamic parameter on regional differences in cerebral oxygenation (ScO2) between brain regions during surgery

  cerebral oxygenation (ScO2) between brain regions will be done by assessing the data collected by the tr-fNIRS monitor during surgery.

  Duration of surgical procedure

Secondary Outcomes (2)

• Regional differences in cerebral autoregulation in beach-chair position under general anesthesia as measured by the tr-fNIRS monitor (Hz) data outputs.

  Duration of surgery

• To assess the association between cerebral desaturation (or hypoxic injury) events in multiple brain regions to clinical outcomes such as stroke and delirium

  Up to 72 hours following surgery or until discharge from hospital.

Study Arms (1)

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.

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

Interventions

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

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.

tr-FNIRS neuromonitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Shoulder surgery patients were chosen as the study population because of the high frequency of intraoperative hypotensive and cerebral desaturation events that may occur during this procedure, and the unique physiological changes such as impaired cerebral autoregulation that accompany the beach chair surgical positioning. This unique but commonly encountered operative condition create ischemic challenges and injury to the brain and provide opportunities to assess the spatial and temporal differences of cerebral desaturation patterns experienced during hypotensive and other physiological challenges, and to refine the tr-fNIRS device for perioperative applications.

You may qualify if:

• Adult patients (age ≥ 18 years old)
• Scheduled to have elective shoulder surgery in the beach-chair position under general anesthesia
• Provide informed consent

You may not qualify if:

• i) have skin/scalp lesions that preclude the application of fNIRS device to the head ii) lack of written consent iii) emergency surgery

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

Related Publications (20)

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• NeuroVISION Investigators. Perioperative covert stroke in patients undergoing non-cardiac surgery (NeuroVISION): a prospective cohort study. Lancet. 2019 Sep 21;394(10203):1022-1029. doi: 10.1016/S0140-6736(19)31795-7. Epub 2019 Aug 15.

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• Ogoh S, Sato K, Okazaki K, Miyamoto T, Secher F, Sorensen H, Rasmussen P, Secher NH. A decrease in spatially resolved near-infrared spectroscopy-determined frontal lobe tissue oxygenation by phenylephrine reflects reduced skin blood flow. Anesth Analg. 2014 Apr;118(4):823-9. doi: 10.1213/ANE.0000000000000145.

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• Milej D, Shahid M, Abdalmalak A, Rajaram A, Diop M, St Lawrence K. Characterizing dynamic cerebral vascular reactivity using a hybrid system combining time-resolved near-infrared and diffuse correlation spectroscopy. Biomed Opt Express. 2020 Jul 23;11(8):4571-4585. doi: 10.1364/BOE.392113. eCollection 2020 Aug 1.

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• Milej D, Abdalmalak A, McLachlan P, Diop M, Liebert A, St Lawrence K. Subtraction-based approach for enhancing the depth sensitivity of time-resolved NIRS. Biomed Opt Express. 2016 Oct 7;7(11):4514-4526. doi: 10.1364/BOE.7.004514. eCollection 2016 Nov 1.

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jason Chui

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Chui

CONTACT

5196858500; Jason.Chui@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Associate Professor

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: March 3, 2023
• Study Start: May 16, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)