NCT06657820

Optical Brain Pulse Monitor: Validation Of Cerebral Oximetry Monitoring (OBPM:VOCOM) Study.

Optical Brain Pulse Monitor: Validation Of Cerebral Oximetry Monitoring (OBPM: VOCOM) Study.

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Elliot Teo · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to calibrate and validate a cerebral oximeter product from Cyban Pty. Ltd. The study will involve comparing cerebral oximeter signals against reference arterial and jugular bulb blood gas measures.

Detailed description

The primary objective of the study is to measure the absolute and relative accuracy of the StO2 device by comparing the NIRS-derived brain tissue oxygen saturation with blood-referenced CO-oximeter oxygen saturation values. The CO-oximeter oxygen saturation values from paired arterial and jugular bulb blood samples are combined into a weighted-equation to derive the reference SavO2. Accuracy is reported over a range of oxygen saturations with study subjects exposed to a controlled oxygen desaturation with serial sampling of paired arterial and internal jugular venous blood gas samples.

Conditions

• Hypoxia

Interventions

Type	Name	Description
PROCEDURE	Hypoxia in healthy individuals	The subject will undergo a graduated desaturation procedure. Arterial saturation targets are as follows: 1. 100% 2. 99% 3. 96% 4. 93% 5. 90% 6. 87% 7. 84% 8. 81% 9. 78% 10. 75% 11. 72% 12. 69% 13. 99%
DEVICE	Cerebral Oximetry	Each subject will be continuously monitored with the cerebral oximetry device throughout the desaturation procedure.
DIAGNOSTIC_TEST	Blood Gas Sampling	At each arterial saturation plateau venous and arterial blood gas measurements will be taken from the jugular bulb, and the radial artery respectively.

Timeline

• Start date: 2025-09-06
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2024-10-26
• Last updated: 2025-06-13