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

Stroke Clinical Trial

Official title:

Full-head Coverage Multi-channel Time-resolved Functional Near Infrared Spectroscopy for Early Detection and Prevention of Perioperative Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752981
• Other study ID #: tr-fNIRS
• Status: Recruiting
• Start date: May 16, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Lawson Health Research Institute
• Contact: Jason Chui
• Phone: 5196858500
• Email: Jason.Chui[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Perioperative stroke is a significant complication after surgery. Unfortunately, covert stroke occurs in one out of fourteen elderly patients after non-cardiac surgery and is associated with an increased risk of long-term cognitive decline. Further, perioperative overt stroke is associated with an 8-fold increase in perioperative mortality, prolonged length of hospital stay, and decreased quality of life. For shoulder surgery performed in the beach chair position, due to systemic hypotension and reduction in cerebral perfusion pressure, cerebral desaturation events and impaired cerebral autoregulation can occur in up to 80% of patients. Most perioperative stroke in non-cardiac surgery is ischemic and is related to brain hypoperfusion. Importantly, brain hypoperfusion is potentially modifiable with simple measures such as increasing systemic blood pressure (BP) if brain ischemia is identified early enough. However, deliberate hypertension is not devoid of risk and there is currently no effective monitor that can detect brain hypoperfusion during surgery.

Cerebral oxygenation has been used clinically as a measure of adequate brain perfusion during surgery. An early clinical trial at Western found that monitoring cerebral oxygenation was associated with fewer cases of major organ dysfunction in cardiac surgery patients. Despite this promising initial finding, current commercial cerebral oximeters have a number of limitations that prevent reliable perioperative neuromonitoring, including non-specificity due to signal contamination from extracerebral tissue, especially during administration of vasoconstrictors or hypothermia. In addition, current commercial cerebral oximeters only have two channels to monitor the frontal lobe regions (i.e., anterior cerebral artery territory). This monitoring strategy assumes that cerebral oxygenation is homogenous across different brain regions so that measurements from the frontal lobe regions can be used clinically to represent the adequacy of global brain oxygenation. Such a limited spatial coverage may result in undetected stroke, despite the patients having apparently normal cerebral oxygenation in the frontal regions throughout surgery. The current research project employs multi-channel tr-fNIRS to address these limitations, with the goal of timely detection and prevention of ischemic brain injury.

Multi-channel tr-fNIRS (time-resolved (tr) functional near infrared spectroscopy (fNIRS) (tr-fNIRS)) is an emerging brain-imaging technology that was originally developed to explore changes in cerebral oxygenation generated by cortical neuronal activity during various cognitive tasks such as speech, sensory and motor functions, and emotion. This is because tr-fNIRS can measure such subtle cerebral oxygenation changes in milliseconds (up to 100 ms) that accompany neuro-activation such as finger-tapping. The investigators has built several tr-fNIRS devices and have the expertise of adapting the full head coverage tr-fNIRS device to perioperative neuromonitoring. Furthermore, tr-fNIRS operate by sending short (picosecond) pulses of light into the head and precisely measures the time of travel of each photon in the tissue. Since there is an equivalence between time and distance, photons that are detected right after the pulse have only probed the extracerebral layers (scalp and skull) while photons that are detected long after (1-2 ms) the pulse have travelled deep into the brain tissues. The investigators have recently shown that this approach reduces the signal contaminations of the extracerebral layers from 80% with current commercial NIRS devices to less than 8% with tr-fNIRS. In this study, the investigators will employ a state-of-the-art full head coverage tr-fNIRS device to monitor the entire brain, as opposed to only select regions (such as the limited capabilities of the current cerebral oximeters) in the perioperative setting. Together with in-house analysis algorithms, the full head coverage tr-fNIRS can detect specific brain regions at-risk of ischemic injury with a high degree of certainty because of greater spatial resolution (in cm) and less signal contamination from extracerebral tissue.

All study participants will be recruited and consented adhering to the local ethics guidelines. For all study participants, the surgical and anesthetic management of the patients will be conducted in a standard fashion and will not be altered in this study. The exception is that tr-fNIRS will be used to monitor regional brain oxygenation from anesthesia induction to completion of surgery. The surgeons, anesthesiologists, and nurses will be blinded to the monitor/measurements during the procedure. No intervention will be administered based on the results of the tr-fNIRS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Cerebral Oxygenation
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (20)

Ban HY, Barrett GM, Borisevich A, Chaturvedi A, Dahle JL, Dehghani H, Dubois J, Field RM, Gopalakrishnan V, Gundran A, Henninger M, Ho WC, Hughes HD, Jin R, Kates-Harbeck J, Landy T, Leggiero M, Lerner G, Aghajan ZM, Moon M, Olvera I, Park S, Patel MJ, Perdue KL, Siepser B, Sorgenfrei S, Sun N, Szczepanski V, Zhang M, Zhu Z. Kernel Flow: a high channel count scalable time-domain functional near-infrared spectroscopy system. J Biomed Opt. 2022 Jan;27(7):074710. doi: 10.1117/1.JBO.27.7.074710. — View Citation

Brady KM, Hudson A, Hood R, DeCaria B, Lewis C, Hogue CW. Personalizing the Definition of Hypotension to Protect the Brain. Anesthesiology. 2020 Jan;132(1):170-179. doi: 10.1097/ALN.0000000000003005. No abstract available. Erratum In: Anesthesiology. 2020 Jul;133(1):250. — View Citation

Erdoes G, Rummel C, Basciani RM, Verma R, Carrel T, Banz Y, Eberle B, Schroth G. Limitations of Current Near-Infrared Spectroscopy Configuration in Detecting Focal Cerebral Ischemia During Cardiac Surgery: An Observational Case-Series Study. Artif Organs. 2018 Oct;42(10):1001-1009. doi: 10.1111/aor.13150. Epub 2018 May 3. — View Citation

Grocott HP, Davie SN. Future uncertainties in the development of clinical cerebral oximetry. Front Physiol. 2013 Dec 18;4:360. doi: 10.3389/fphys.2013.00360. eCollection 2013. No abstract available. — View Citation

Joshi B, Ono M, Brown C, Brady K, Easley RB, Yenokyan G, Gottesman RF, Hogue CW. Predicting the limits of cerebral autoregulation during cardiopulmonary bypass. Anesth Analg. 2012 Mar;114(3):503-10. doi: 10.1213/ANE.0b013e31823d292a. Epub 2011 Nov 21. — View Citation

Lee JH, Min KT, Chun YM, Kim EJ, Choi SH. Effects of beach-chair position and induced hypotension on cerebral oxygen saturation in patients undergoing arthroscopic shoulder surgery. Arthroscopy. 2011 Jul;27(7):889-94. doi: 10.1016/j.arthro.2011.02.027. Epub 2011 May 28. — View Citation

Lee JM, Grabb MC, Zipfel GJ, Choi DW. Brain tissue responses to ischemia. J Clin Invest. 2000 Sep;106(6):723-31. doi: 10.1172/JCI11003. No abstract available. — View Citation

Mashour GA, Shanks AM, Kheterpal S. Perioperative stroke and associated mortality after noncardiac, nonneurologic surgery. Anesthesiology. 2011 Jun;114(6):1289-96. doi: 10.1097/ALN.0b013e318216e7f4. — View Citation

McCulloch TJ, Liyanagama K, Petchell J. Relative hypotension in the beach-chair position: effects on middle cerebral artery blood velocity. Anaesth Intensive Care. 2010 May;38(3):486-91. doi: 10.1177/0310057X1003800312. — View Citation

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. — View Citation

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. — View Citation

Mrkobrada M, Hill MD, Chan MT, Sigamani A, Cowan D, Kurz A, Sessler DI, Jacka M, Graham M, Dasgupta M, Dunlop V, Emery DJ, Gulka I, Guyatt G, Heels-Ansdell D, Murkin J, Pettit S, Sahlas DJ, Sharma M, Sharma M, Srinathan S, St John P, Tsai S, Gelb AW, O'Donnell M, Siu D, Chiu PW, Sharath V, George A, Devereaux PJ. Covert stroke after non-cardiac surgery: a prospective cohort study. Br J Anaesth. 2016 Aug;117(2):191-7. doi: 10.1093/bja/aew179. — 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

Murphy GS, Szokol JW, Marymont JH, Greenberg SB, Avram MJ, Vender JS, Vaughn J, Nisman M. Cerebral oxygen desaturation events assessed by near-infrared spectroscopy during shoulder arthroscopy in the beach chair and lateral decubitus positions. Anesth Analg. 2010 Aug;111(2):496-505. doi: 10.1213/ANE.0b013e3181e33bd9. Epub 2010 May 27. — View Citation

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. — View Citation

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. — View Citation

Ono M, Joshi B, Brady K, Easley RB, Zheng Y, Brown C, Baumgartner W, Hogue CW. Risks for impaired cerebral autoregulation during cardiopulmonary bypass and postoperative stroke. Br J Anaesth. 2012 Sep;109(3):391-8. doi: 10.1093/bja/aes148. Epub 2012 Jun 1. — View Citation

Salazar D, Sears BW, Aghdasi B, Only A, Francois A, Tonino P, Marra G. Cerebral desaturation events during shoulder arthroscopy in the beach chair position: patient risk factors and neurocognitive effects. J Shoulder Elbow Surg. 2013 Sep;22(9):1228-35. doi: 10.1016/j.jse.2012.12.036. Epub 2013 Feb 15. — 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

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Regional differences in cerebral autoregulation in beach-chair position under general anesthesia as measured by the tr-fNIRS monitor (Hz) data outputs.	Cerebral autoregulation index will be calculated based on the data collected by the tr-fNIRS monitor during surgery.	Duration of surgery
Secondary	To assess the association between cerebral desaturation (or hypoxic injury) events in multiple brain regions to clinical outcomes such as stroke and delirium	Covert stroke will be assessed by performing a postoperative MRI. Neurological deficits will be assessed by physical examination and delirium will be assessed by 3D CAM administration).	Up to 72 hours following surgery or until discharge from hospital.