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

NCT06657820 | Withdrawn

• 1 other identifier: Pro00116391
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypoxia

Keywords

Cerebral Oximetry; Hypoxia

Outcome Measures

Primary Outcomes (2)

• 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

  6 months

• 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

  6 months

Secondary Outcomes (4)

• Concordance Correlation Coefficient

  6 months

• Passing-Bablok Regression Analysis

  6 months

• Linear Mixed Model Regression Analysis

  6 months

• Subgroup Analysis of Agreement

  6 months

Other Outcomes (1)

• Safety Analyses

  6 months

Study Arms (1)

Desaturation

EXPERIMENTAL

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.

Procedure: Hypoxia in healthy individuals; Device: Cerebral Oximetry; Diagnostic Test: Blood Gas Sampling

Interventions

Hypoxia in healthy individuals 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%

Desaturation

Cerebral Oximetry DEVICE

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

Desaturation

Blood Gas Sampling 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.

Desaturation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 \[assessment by PI or delegate\];

Sponsors & Collaborators

• Elliot Teo: lead
• Duke University Hospital, USA: collaborator

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David B Macleod, M.B.B.S

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Manager

Model Details: 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.

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 26, 2024
• Study Start: September 6, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: June 13, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share