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

NCT06657820 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-06-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Duke University Hospital, USA

    collaborator UNKNOWN

  • Elliot Teo

    lead INDUSTRY

Principal Investigators

  • David B Macleod, M.B.B.S · Human Pharmacology and Physiology Lab, Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-06
Primary Completion
2025-12-30
Completion
2025-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06657820 on ClinicalTrials.gov