Cerebral Injury Clinical Trial
Official title:
Evaluation of Cerebral Oxygenation Using Functional Near Infrared Spectroscopy in Adult Surgery
NCT number | NCT04574440 |
Other study ID # | FNIRS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 20, 2019 |
Est. completion date | December 30, 2025 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
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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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Erratum In: Anesthesiology. 2019 Feb;130(2):360. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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