NCT03907904

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
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Western University, Canada · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Hypoxia Ischemia

Interventions

Type	Name	Description
DEVICE	CPOM 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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2023-02-24
• Completion: 2023-02-24
• First posted: 2019-04-09
• Last updated: 2025-01-27

Locations

1 site across 1 country: Canada