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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03907904
Enrollment
50
Registered
2019-04-09
Start date
2019-07-01
Completion date
2023-02-24
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Hypoxia Ischemia

Keywords

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

Brief 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.

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.

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.

Sponsors

Western University, Canada
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Brain cytochrome C oxidase level.IntraoperativeThe cytochrome C oxidase level which reflects the brain oxidative metabolism will be measured by a CPOM Optical Neuromonitor.
Brain saturation (ScO2)IntraoperativeThe brain saturation (ScO2) (%) will be measured by a CPOM Optical Neuromonitor.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026