Clinical trial NCT03907904: Continuous, Non-invasive Monitoring of Intraoperative Cerebral Perfusion and Oxidative Metabolism (CPOM)
Official title: Continuous, Non-invasive Monitoring of Intraoperative Cerebral Perfusion and Oxidative Metabolism (CPOM): a Knowledge Translation Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for surgery requiring general anesthesia and required to have an arterial line.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Brain cytochrome C oxidase level.
timeFrame: Intraoperative
measure: Brain saturation (ScO2)
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Jason Chui, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
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