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

NCT ID: NCT06657820

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-06
• Study Completion Date: 2025-12-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Desaturation

A central venous catheter will be placed in the right internal jugular vein and the catheter tip advanced retrograde to lie at the level of the jugular bulb. An arterial catheter will be placed in the forearm. A dedicated breathing circuit will be used to reduce the alveolar oxygen tension (PAO2) in stepwise fashion to produce a controlled oxygen desaturation sequence. The dedicated breathing circuit will be used to maintain the alveolar carbon dioxide tension (PACO2) at normocapnic value of 40 mmHg. At each step once steady state conditions are achieved, serial paired arterial and jugular bulb venous samples will be drawn. The blood gas samples will be analyzed by Radiometer ABL90 Flex CO-oximeter.

Group Type: EXPERIMENTAL

Hypoxia in healthy individuals

Intervention Type: PROCEDURE

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%

Cerebral Oximetry

Intervention Type: DEVICE

Each subject will be continuously monitored with the cerebral oximetry device throughout the desaturation procedure.

Blood Gas Sampling

Intervention Type: DIAGNOSTIC_TEST

At each arterial saturation plateau venous and arterial blood gas measurements will be taken from the jugular bulb, and the radial artery respectively.

Interventions

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%

Intervention Type: PROCEDURE

Cerebral Oximetry

Each subject will be continuously monitored with the cerebral oximetry device throughout the desaturation procedure.

Intervention Type: DEVICE

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Healthy, male or female subjects between the ages of 18 to 45 years;
• Completion of a health screening for a medical history by a licensed physician, nurse practitioner, or physician assistant;
• Minimum weight 40kg;
• BMI within range 18.0 - 35.0;
• Assigned American Society of Anesthesiologists (ASA) Physical Status 1 by Principal Investigator or delegate

Exclusion Criteria

• Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) [self- reported];
• Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported];
• Taking any medication other than birth control[self-reported];
• Is currently participating in, or has recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study [self- reported];
• Has a negative Allen's Test to confirm non-patency of the collateral artery [clinical assessment by PI or delegate];
• Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure [self-reported];
• Is female with a positive pregnancy test [serum or urine], or is female and is unwilling to use effective birth control between the time of screening and study procedure or is breast feeding;
• Has anemia [lab values specific for gender];
• Has heparin allergy
• Has a history of sickle cell trait or thalassemia [self-reported];
• Has an abnormal hemoglobin electrophoresis result [lab measurement];
• Has a positive urine cotinine test or urine drug screen or oral ethanol test;
• Has a room air saturation less than 95% by pulse oximetry [measurement by PI or delegate]
• Has a clinically significant abnormal EKG [assessment by PI or delegate];
• Has a clinically significant abnormal pulmonary function test via spirometry [assessment by PI or delegate];
• Has a COHb greater than 3%, or MetHb greater than 2% [measured by venous blood sample co- oximetry].
• Students and Employees under the direct supervision of PI or Sub-I.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University Hospital, USA

UNKNOWN

Sponsor Role: collaborator

Elliot Teo

INDUSTRY

Sponsor Role: lead

Responsible Party

Elliot Teo

Clinical Research Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

David B Macleod, M.B.B.S

Role: PRINCIPAL_INVESTIGATOR

Human Pharmacology and Physiology Lab, Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA

Other Identifiers

Pro00116391

Identifier Type: -

Identifier Source: org_study_id