Recruiting

Functional Near Infrared Spectroscopy

Sponsor:

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

Code:

NCT04574440

Conditions

Cerebral Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

multichannel fNIRS monitoring

Study Details

Brief summary:

Brain injury is a serious problem after cardiac surgery. Brain injury can become evident in the form of stroke and cognitive dysfunction after surgery. The current neuromonitoring technique used is unable to monitor the region of the brain that is most susceptible to injury. This study aims to use a novel, non-invasive brain monitoring technique known as multichannel functional near infrared spectroscopy to assess brain oxygenation at multiple brain regions simultaneously during cardiac surgery. This research enables the investigators to understand the differences between regional brain oxygenation during cardiac surgery and to assess the feasibility and effectiveness of multichannel functional near infrared spectroscopy to be used as a future brain monitoring technique to detect brain injury in cardiac surgery.

Conditions

Cerebral Injury

Study ID

NCT04574440

Start date

Dec 20, 2019

Status verified date

Jun, 2024

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult cardiac surgery patients who are scheduled to have elective cardiac operations.

Exclusion Criteria:

  • Under 18 years of age
  • have skin lesions or other conditions that preclude the application of fNIRS to the head
  • lack of written consent
  • emergency surgery

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

multichannel fNIRS monitoring

Patients who will be enrolled in this study will be monitored during cardiac surgery using multichannel fNIRS monitoring. This consists of wearing the NIRS cap during surgery. The patient's surgery and subsequent medical care will not be altered.

Interventions

multichannel fNIRS monitoring

Patients who will be enrolled in this study will be monitored during cardiac surgery using multichannel fNIRS monitoring. This consists of wearing the NIRS cap that will be positioned on the patient's head according to international operational guidelines and will be secured to the temporal region of the patient's forehead. The NIRS cap is entirely non-invasive and does not pose any additional risk to the patient. Monitoring will be commenced prior to the induction of anesthesia. Subsequent surgical and medical care will not be affected.

Primary outcome measure

  • feasibility of using multichannel fNIRS to detect and monitor cerebral oxygenation of multiple brain regions during cardiac surgery measured by detecting cortical hemodynamic and metabolic changes in different brain regions. [ Time Frame: During the procedure/surgery ]
  • Describe the regional cerebral oxygenation changes during cardiac surgery measured by using using multichannel fNIRS [ Time Frame: During the procedure/surgery ]

Central Contacts and Locations

Central contacts

Jason Chui, MD

5196858500jason.chui@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Jason Chui, MD

5196858500jason.chui@lhsc.on.ca

More Information

Sponsor

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

Last update posted

Jun 4, 2024

Last verified

Jun, 2024

Keywords

  • multichannel functional near infrared spectroscopy (fNIRS)
  • cerebral oxygenation
  • cardiac surgery

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 2024-06-04.