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Brain Hypoxia IschemiaNCT03907904

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

An observational study of Brain Hypoxia Ischemia, run by Western University, Canada at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Hypoxia Ischemia
What is being tested?
CPOM Optical Neuromonitor
Type of treatment
Medical device
How many people
50 participants
Where
1 siteCanada
Study dates
1 Jul 2019to 24 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • All adult surgical patients (>18 year-old) who require general anesthesia for their surgery
  • Patients required an arterial line for his/her procedure

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Health Sciences Centre

    London, Ontario

Other trials in Canada

About this study

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

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.

Being tested
CPOM Optical Neuromonitor
Keywords
Intraoperative/methods* Oximetry/methods* Oxygen/metabolism, brain/metabolism, brain chemistry, cerebrovascular circulation, humans, monitoring, intraoperative/methods, oximetry/methods, oxygen/metabolism
Medical subject headings
Hypoxia-Ischemia, Brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPOM Optical NeuromonitorDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Intraoperative

  2. Brain saturation (ScO2)

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

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2019
  2. Study start1 Jul 2019
  3. Primary completion24 Feb 2023
  4. Study completion24 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03907904
Sponsor's protocol ID
113650
Status last verified
Oct 2020
First submitted
5 Mar 2019
Last updated
27 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    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.

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Hypoxia Ischemia, run by Western University, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain cytochrome C oxidase level. (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03907904, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.

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