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CompletedNCT03907904Updated Jan 27, 2025

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

An observational study in Brain Hypoxia Ischemia, sponsored by Western University, Canada. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by Western University, Canada · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 19 studies in Hypoxia-Ischemia, Brain with a site in Canada — 10 open to participants now, 10 under way, none of them phase 3. Hypoxia-Ischemia, Brain · Canada.

Started
2019
the only one that year
Observational
5 of 19
2 open now
Registered
7th of 19
by date

Among the 19 studies in Hypoxia-Ischemia, Brain with a site in Canada, this one is the only one that started in 2019, is one of 5 observational ones, and was the 7th registered.

Hypoxia-Ischemia, Brain

261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.

Browse Hypoxia-Ischemia, Brain studies →

Open to participants now

10 of the 19 studies in Hypoxia-Ischemia, Brain with a site in Canada are open now. Recruiting first, the newest first:

5 more — sign in →

All 10 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 60 Hypoxia-Ischemia, Brain studies recruiting now, 21 (35%) set no upper age limit and 37 (62%) stop at 75 or younger; 46 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 19 studies in Hypoxia-Ischemia, Brain with a site in Canada, or all of them as a file.
02

Study 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.

Read the detailed 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 50 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 general anesthesia/cardiopulmonary bypass (CPB). This study represents the first opportunity to assess this combined technology in adult patients and will provide important data to support further investigations in brain-at-risk patients.

These 50 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 (especially hypotension) using a CPOM device. Cerebral auto regulation indices will also be determined. No intervention will be applied.

03

Conditions studied

  • Brain Hypoxia Ischemia

Keywords

  • Intraoperative/methods* Oximetry/methods* Oxygen/metabolism
  • brain/metabolism
  • brain chemistry
  • cerebrovascular circulation
  • humans
  • monitoring, intraoperative/methods
  • oximetry/methods
  • oxygen/metabolism
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted for surgery requiring general anesthesia and required to have an arterial line.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Emergency surgery
  • Unable to obtain consent
  • Condition that preclude the use of CPOM monitor (e.g. skin lesion in the forehead)
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • DeviceCPOM 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.

06

What researchers measure

Primary outcomes

  1. Brain cytochrome C oxidase level.

    The cytochrome C oxidase level which reflects the brain oxidative metabolism will be measured by a CPOM Optical Neuromonitor.

    Time frame: Intraoperative

  2. Brain saturation (ScO2)

    The brain saturation (ScO2) (%) will be measured by a CPOM Optical Neuromonitor.

    Time frame: Intraoperative

07

Study locations

1 site
  • London Health Sciences Centre
    London, Ontario, Canada
08

References and documents

Publications

  • Bale G, Elwell CE, Tachtsidis I. Errata: From Jobsis 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. No abstract available. PubMed 27411110 ↗
  • 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. PubMed 28685438 ↗
  • 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. PubMed 30258675 ↗
  • 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. PubMed 26504641 ↗
  • 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. PubMed 17179242 ↗
  • 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. PubMed 22343469 ↗
  • 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. PubMed 24651237 ↗
  • 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. No abstract available. PubMed 23543201 ↗
  • Olesen ND, Sorensen 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. PubMed 28293809 ↗
  • 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. PubMed 23959202 ↗
  • 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. PubMed 18759572 ↗
  • 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. doi: 10.1364/BOE.3.001476. PubMed 21750781 ↗
  • Durduran T, Yodh AG. Diffuse correlation spectroscopy for non-invasive, micro-vascular cerebral blood flow measurement. Neuroimage. 2014 Jan 15;85 Pt 1(0 1):51-63. doi: 10.1016/j.neuroimage.2013.06.017. Epub 2013 Jun 14. PubMed 23770408 ↗
  • 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. PubMed 26384626 ↗
  • 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.
  • 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. doi: 10.1016/s0003-4975(10)62316-8. PubMed 6439135 ↗
  • Lundar T, Froysaker 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. doi: 10.1016/s0003-4975(10)62621-5. PubMed 3985707 ↗
  • 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. doi: 10.1364/BOE.7.003659. eCollection 2016 Sep 1. PubMed 27699127 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2019 to primary completion in Feb 2023, 43 months.

Of 46 non-industry observational studies under Hypoxia-Ischemia, Brain, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20. This study's 43 months is close to that.

Counting every sponsor, half of 50 studies reached it within 43 months; a quarter within 20.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2019
First posted
Apr 9, 2019
StartActual
Jul 1, 2019
Primary completionActual
Feb 24, 2023
CompletionActual
Feb 24, 2023
Last update
Jan 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03907904
Responsible party
Sponsor
First posted
Apr 9, 2019
Start date
Jul 1, 2019
Primary completion
Feb 24, 2023
Completion
Feb 24, 2023
Last update
Jan 27, 2025

Study contacts

Jason Chui, MBChB
principal investigator · Western University, Canada

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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