Continuous, Non-invasive Monitoring of Intraoperative Cerebral Perfusion and Oxidative Metabolism (CPOM)

Brain Hypoxia Ischemia Clinical Trial

Official title:

Continuous, Non-invasive Monitoring of Intraoperative Cerebral Perfusion and Oxidative Metabolism (CPOM): a Knowledge Translation Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03907904
• Other study ID #: 113650
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Western University, Canada
• Contact: Jason Chui, MBChB
• Phone: 5196858500
• Email: jason.chui[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study uses a CPOM Optical neuromonitor to assess the relationship between brain cytochrome C oxidase, cerebral oxygen saturation and blood pressure during surgery performed under general anesthesia.

Description:

During various surgical procedures, blood supply to the brain can be jeopardized either due to interruption of flow as occurs during carotid surgery, or due to inadequate arterial pressure which can occur in settings as diverse as heart surgery or shoulder surgery. This is a prospective observational study of brain oxygen levels, brain metabolism and blood pressure in 40 adult surgical patients under general anesthesia using a CPOM Optical neuromonitor.

This is an observational study. The primary objective of this study is to describe the changes in redox state of brain CCO (reflecting oxidative metabolism), CBFi, and brain tissue oxygen saturation in relation to systemic blood pressure in patients during the transition from the awake state to general anesthesia. This study represents the first opportunity to assess this combined technology in adult patients and will provide important pilot data to support further investigations in brain-at-risk patients.

These 40 patients will be used to help the investigators to obtain pilot data about the relationship between brain cytochrome C oxidase (bCCO), cerebral oxygen saturation (ScO2), and blood pressure using a CPOM device. No intervention will be applied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All adult surgical patients (>18 year-old) who require general anesthesia for their surgery

• Patients required an arterial line for his/her procedure

Exclusion Criteria:

• Emergency surgery

• Unable to obtain consent

• Condition that preclude the use of CPOM monitor (e.g. skin lesion in the forehead)

Related Conditions & MeSH terms

• Brain Hypoxia Ischemia
• Hypoxia
• Hypoxia, Brain
• Hypoxia-Ischemia, Brain
• Ischemia

Intervention

Device:
• CPOM Optical Neuromonitor
Prior to induction of anesthesia, the CPOM monitor will be secured to the temporal region of the participant's forehead to measure and record the cerebral hemodynamic data before, during, and following intubation. Hemodynamic, respiratory, body temperature, and anesthetic data will be continuously digitally records. The CPOM device will be detached after extubation in the operative room.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (18)

Bainbridge A, Tachtsidis I, Faulkner SD, Price D, Zhu T, Baer E, Broad KD, Thomas DL, Cady EB, Robertson NJ, Golay X. Brain mitochondrial oxidative metabolism during and after cerebral hypoxia-ischemia studied by simultaneous phosphorus magnetic-resonance and broadband near-infrared spectroscopy. Neuroimage. 2014 Nov 15;102 Pt 1:173-83. doi: 10.1016/j.neuroimage.2013.08.016. Epub 2013 Aug 17. Review. — View Citation

Bale G, Elwell CE, Tachtsidis I. Errata: From Jöbsis to the present day: a review of clinical near-infrared spectroscopy measurements of cerebral cytochrome-c-oxidase. J Biomed Opt. 2016 Sep;21(9):099801. doi: 10.1117/1.JBO.21.9.099801. — View Citation

Davie SN, Grocott HP. Impact of extracranial contamination on regional cerebral oxygen saturation: a comparison of three cerebral oximetry technologies. Anesthesiology. 2012 Apr;116(4):834-40. doi: 10.1097/ALN.0b013e31824c00d7. — View Citation

de Roever I, Bale G, Cooper RJ, Tachtsidis I. Functional NIRS Measurement of Cytochrome-C-Oxidase Demonstrates a More Brain-Specific Marker of Frontal Lobe Activation Compared to the Haemoglobins. Adv Exp Med Biol. 2017;977:141-147. doi: 10.1007/978-3-319-55231-6_19. — View Citation

Diop M, Kishimoto J, Toronov V, Lee DS, St Lawrence K. Development of a combined broadband near-infrared and diffusion correlation system for monitoring cerebral blood flow and oxidative metabolism in preterm infants. Biomed Opt Express. 2015 Sep 10;6(10):3907-18. doi: 10.1364/BOE.6.003907. eCollection 2015 Oct 1. — View Citation

Diop M, Verdecchia K, Lee TY, St Lawrence K. Calibration of diffuse correlation spectroscopy with a time-resolved near-infrared technique to yield absolute cerebral blood flow measurements. Biomed Opt Express. 2011 Jul 1;2(7):2068-81. doi: 10.1364/BOE.2.002068. Epub 2011 Jun 28. Erratum in: Biomed Opt Express. 2012 Jun 1;3(6):1476-7. — View Citation

Durduran T, Yodh AG. Diffuse correlation spectroscopy for non-invasive, micro-vascular cerebral blood flow measurement. Neuroimage. 2014 Jan 15;85 Pt 1:51-63. doi: 10.1016/j.neuroimage.2013.06.017. Epub 2013 Jun 14. Review. — View Citation

Govier AV, Reves JG, McKay RD, Karp RB, Zorn GL, Morawetz RB, Smith LR, Adams M, Freeman AM. Factors and their influence on regional cerebral blood flow during nonpulsatile cardiopulmonary bypass. Ann Thorac Surg. 1984 Dec;38(6):592-600. — View Citation

Lundar T, Frøysaker T, Lindegaard KF, Wiberg J, Lindberg H, Rostad H, Nornes H. Some observations on cerebral perfusion during cardiopulmonary bypass. Ann Thorac Surg. 1985 Apr;39(4):318-23. — View Citation

McManus R, Froats E, St Lawrence K, Vanuum S, Diop M. Dynamic Relationship between Cerebral Blood Flow and Symptoms of Hypoglycemia. Canadian Journal of Diabetes 42(5): S12, 2018.

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. — View Citation

Murkin JM, Kamar M, Silman Z, Balberg M, Adams SJ. Intraoperative Cerebral Autoregulation Assessment Using Ultrasound-Tagged Near-Infrared-Based Cerebral Blood Flow in Comparison to Transcranial Doppler Cerebral Flow Velocity: A Pilot Study. J Cardiothorac Vasc Anesth. 2015 Oct;29(5):1187-93. doi: 10.1053/j.jvca.2015.05.201. Epub 2015 May 27. — View Citation

Murkin JM. Is it better to shine a light, or rather to curse the darkness? Cerebral near-infrared spectroscopy and cardiac surgery. Eur J Cardiothorac Surg. 2013 Jun;43(6):1081-3. doi: 10.1093/ejcts/ezt186. Epub 2013 Mar 29. — View Citation

Ogoh S, Sato K, Okazaki K, Miyamoto T, Secher F, Sørensen 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

Olesen ND, Sørensen H, Ambrus R, Svendsen LB, Lund A, Secher NH. A mesenteric traction syndrome affects near-infrared spectroscopy evaluated cerebral oxygenation because skin blood flow increases. J Clin Monit Comput. 2018 Apr;32(2):261-268. doi: 10.1007/s10877-017-0014-2. Epub 2017 Mar 14. — View Citation

Rajaram A, Bale G, Kewin M, Morrison LB, Tachtsidis I, St Lawrence K, Diop M. Simultaneous monitoring of cerebral perfusion and cytochrome c oxidase by combining broadband near-infrared spectroscopy and diffuse correlation spectroscopy. Biomed Opt Express. 2018 May 10;9(6):2588-2603. doi: 10.1364/BOE.9.002588. eCollection 2018 Jun 1. — View Citation

Tisdall MM, Tachtsidis I, Leung TS, Elwell CE, Smith M. Increase in cerebral aerobic metabolism by normobaric hyperoxia after traumatic brain injury. J Neurosurg. 2008 Sep;109(3):424-32. doi: 10.3171/JNS/2008/109/9/0424. — View Citation

Verdecchia K, Diop M, Lee A, Morrison LB, Lee TY, St Lawrence K. Assessment of a multi-layered diffuse correlation spectroscopy method for monitoring cerebral blood flow in adults. Biomed Opt Express. 2016 Aug 24;7(9):3659-3674. eCollection 2016 Sep 1. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain cytochrome C oxidase level.	The cytochrome C oxidase level which reflects the brain oxidative metabolism will be measured by a CPOM Optical Neuromonitor.	Intraoperative
Primary	Brain saturation (ScO2)	The brain saturation (ScO2) (%) will be measured by a CPOM Optical Neuromonitor.	Intraoperative