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

Completed

• Conditions: Brain Hypoxia Ischemia

• Registration Number: NCT03907904
• Lead Sponsor: Western University, Canada

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.

Study Timeline

• Study First Submitted: 2019-03-05
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-09
• Study Start: 2019-07-01
• Status Verified: 2020-10
• Primary Completion: 2023-02-24
• Study Completion: 2023-02-24
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain saturation (ScO2)	Intraoperative	The brain saturation (ScO2) (%) will be measured by a CPOM Optical Neuromonitor.
Brain cytochrome C oxidase level.	Intraoperative	The cytochrome C oxidase level which reflects the brain oxidative metabolism will be measured by a CPOM Optical Neuromonitor.

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada