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HypoxiaOBPM:VOCOMNCT06657820

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

A study testing Hypoxia in healthy individuals, Cerebral Oximetry and Blood Gas Sampling in people with Hypoxia, run by Elliot Teo.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Hypoxia
What is being tested?
Hypoxia in healthy individuals, Cerebral Oximetry and Blood Gas Sampling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
6 Sep 2025to 30 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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];
Show all 17Show fewer
  • 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.

About this study

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

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.

Read the 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
Being tested
Hypoxia in healthy individuals, Cerebral Oximetry, Blood Gas Sampling
Keywords
Cerebral Oximetry, Hypoxia
Medical subject headings
Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypoxia in healthy individualsProcedure or surgery

    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 OximetryDevice

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

  • Blood Gas SamplingDiagnostic test

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

Study groups in NCT06657820
Study groupRoleWhat they receive
DesaturationExperimentalA 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.
Receives: Procedure: Hypoxia in healthy individuals; Device: Cerebral Oximetry; Diagnostic Test: Blood Gas Sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy by Average Root Mean Squared Error

    The Accuracy by Root Mean Square Difference (ARMS) will be used to evaluate accuracy of the investigational device StO2 compared with the blood-referenced SavO2

    Measured: 6 months

  2. Bland-Altman Agreement Analysis

    A Bland-Altman (BA) analysis will be conducted on the difference (D) and mean (A) of StO2, SavO2, where

    • D = StO2 - SavO2
    • A = (StO2 + SavO2) / 2

    The following statistics will be presented:

    • Bias and its 95% confidence interval (CI)
    • Standard deviation of bias (sum of between and within subject variance components)
    • Lower and upper 95% limit of agreement (LoA) and their 95% CI

    Measured: 6 months

Secondary outcomes (4)

  1. Concordance Correlation Coefficient

    The concordance correlation coefficient (CCC) method is used to measure the agreement between of two devices. CCC could have values from -1 to 1, with values near 1 indicating strong concordance between the two devices, values near -1 indicating strong discordance, and values near zero indicating no concordance.

    Measured: 6 months

  2. Passing-Bablok Regression Analysis

    Passing-Bablok regression is used to compare measurements from different devices, and is a robust nonparametric regression method that does not make assumptions about the distribution of the expected values or the error terms in the model. The 95% CI for the intercept and slope will be estimated from the regression.

    Measured: 6 months

  3. Linear Mixed Model Regression Analysis

    A random effects linear mixed model will be used to regress StO2 on SavO2. Subject will be included as a random effect in the model to account for the correlation of repeated measures within the same subject.

    Measured: 6 months

  4. Subgroup Analysis of Agreement

    Bland-Altman analyses will be generated for subgroups to assess the two device agreement among different subgroups. A forest plot will used to present the results. The following subgroups will be considered.

    • Restricted oxygen desaturation range: 50% ≤ reference SavO2 ≤ 75%
    • Oxygen desaturation steps as measured by SpO2 (13 steps)
    • Fitzpatrick score group
    • Sex
    • Race

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2024
  2. Study start6 Sep 2025 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Why it stopped: The decision was made to withdraw this study prior to recruitment to make further changes to the investigational device.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Subject will undergo a graduated desaturation protocol beginning at 100%, then 99%, then descending in 3% increments to a final target of 66%. Arterial and venous jugular bulb co-oximetry measurements will be taken at each saturation plateau yielding a total of 13 paired samples per subject. The weighted average of the SaO2 and the SvO2 will be compared against the Cyban Cerebral Oximeter.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06657820
Sponsor's protocol ID
Pro00116391
Acronym
OBPM:VOCOM
Status last verified
Sep 2024
First submitted
15 Oct 2024
Last updated
13 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share individual participant data.

Questions about this trial

What is this clinical trial studying?

A study testing Hypoxia in healthy individuals, Cerebral Oximetry and Blood Gas Sampling in people with Hypoxia, run by Elliot Teo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy by Average Root Mean Squared Error (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06657820.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.

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