Functional Near Infrared Spectroscopy in Adult Surgery

NCT04574440 | Recruiting

• 1 other identifier: FNIRS
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  Assess the feasibility of using multichannel fNIRS to detect and monitor cerebral oxygenation of multiple brain regions during cardiac surgery. This will be measured by using the multichannel fNIRS monitor during cardiac surgery and to determine if this monitor can detect cortical hemodynamic and metabolic changes in different brain regions. Data will be acquired using the NIRStar Software v14.0 (NIRx Medical Technologies LLC, Berlin, Germany) at a sampling rate of 10Hz.

  During the procedure/surgery

• Describe the regional cerebral oxygenation changes during cardiac surgery measured by using using multichannel fNIRS

  Describe the regional cerebral oxygenation changes during cardiac surgery. This will be measured by using multichannel fNIRS during cardiac surgery and determining whether it can detect differences in brain oxygenation in different regions of the brain. Data will be acquired using the NIRStar Software v14.0 (NIRx Medical Technologies LLC, Berlin, Germany) at a sampling rate of 10Hz .

  During the procedure/surgery

Study Arms (1)

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.

Device: multichannel fNIRS monitoring

Interventions

multichannel fNIRS monitoring DEVICE

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.

multichannel fNIRS monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult cardiac surgery patients who are scheduled to have elective cardiac operations. The type of cardiac surgery is not restricted.

You may qualify if:

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

You may not qualify if:

• 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

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 5W9, Canada

RECRUITING

Related Publications (10)

• McKhann GM, Grega MA, Borowicz LM Jr, Baumgartner WA, Selnes OA. Stroke and encephalopathy after cardiac surgery: an update. Stroke. 2006 Feb;37(2):562-71. doi: 10.1161/01.STR.0000199032.78782.6c. Epub 2005 Dec 22.

  PMID: 16373636 BACKGROUND

• Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. doi: 10.1056/NEJM199612193352501.

  PMID: 8948560 BACKGROUND

• Rankin JM, Silbert PL, Yadava OP, Hankey GJ, Stewart-Wynne EG. Mechanism of stroke complicating cardiopulmonary bypass surgery. Aust N Z J Med. 1994 Apr;24(2):154-60. doi: 10.1111/j.1445-5994.1994.tb00551.x.

  PMID: 8042943 BACKGROUND

• Salazar JD, Wityk RJ, Grega MA, Borowicz LM, Doty JR, Petrofski JA, Baumgartner WA. Stroke after cardiac surgery: short- and long-term outcomes. Ann Thorac Surg. 2001 Oct;72(4):1195-201; discussion 1201-2. doi: 10.1016/s0003-4975(01)02929-0.

  PMID: 11603436 BACKGROUND

• Tufo HM, Ostfeld AM, Shekelle R. Central nervous system dysfunction following open-heart surgery. JAMA. 1970 May 25;212(8):1333-40. No abstract available.

  PMID: 5467674 BACKGROUND

• Gardner TJ, Horneffer PJ, Manolio TA, Pearson TA, Gott VL, Baumgartner WA, Borkon AM, Watkins L Jr, Reitz BA. Stroke following coronary artery bypass grafting: a ten-year study. Ann Thorac Surg. 1985 Dec;40(6):574-81. doi: 10.1016/s0003-4975(10)60352-9.

  PMID: 3878134 BACKGROUND

• Sun LY, Chung AM, Farkouh ME, van Diepen S, Weinberger J, Bourke M, Ruel M. Defining an Intraoperative Hypotension Threshold in Association with Stroke in Cardiac Surgery. Anesthesiology. 2018 Sep;129(3):440-447. doi: 10.1097/ALN.0000000000002298.

  PMID: 29889106 BACKGROUND

• Gottesman RF, Sherman PM, Grega MA, Yousem DM, Borowicz LM Jr, Selnes OA, Baumgartner WA, McKhann GM. Watershed strokes after cardiac surgery: diagnosis, etiology, and outcome. Stroke. 2006 Sep;37(9):2306-11. doi: 10.1161/01.STR.0000236024.68020.3a. Epub 2006 Jul 20.

  PMID: 16857947 BACKGROUND

• Malone M, Prior P, Scholtz CL. Brain damage after cardiopulmonary by-pass: correlations between neurophysiological and neuropathological findings. J Neurol Neurosurg Psychiatry. 1981 Oct;44(10):924-31. doi: 10.1136/jnnp.44.10.924.

  PMID: 7310410 BACKGROUND

• Murkin JM, Adams SJ, Novick RJ, Quantz M, Bainbridge D, Iglesias I, Cleland A, Schaefer B, Irwin B, Fox S. Monitoring brain oxygen saturation during coronary bypass surgery: a randomized, prospective study. Anesth Analg. 2007 Jan;104(1):51-8. doi: 10.1213/01.ane.0000246814.29362.f4.

  PMID: 17179242 BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jason Chui, MD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Chui, MD

CONTACT

5196858500; jason.chui@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: October 5, 2020
• Study Start: December 20, 2019
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)