Clinical trial NCT06657820: Optical Brain Pulse Monitor: Validation Of Cerebral Oximetry Monitoring (OBPM:VOCOM) Study.
Official title: Optical Brain Pulse Monitor: Validation Of Cerebral Oximetry Monitoring (OBPM: VOCOM) Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypoxia
Keywords: Cerebral Oximetry
Hypoxia
Lead sponsor: Cyban Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Duke University Hospital, USA
First posted: 2024-10-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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\&#39;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.

Primary outcomes:
measure: Accuracy by Average Root Mean Squared Error
timeFrame: 6 months
measure: Bland-Altman Agreement Analysis
timeFrame: 6 months
Secondary outcomes:
measure: Concordance Correlation Coefficient
timeFrame: 6 months
measure: Passing-Bablok Regression Analysis
timeFrame: 6 months
measure: Linear Mixed Model Regression Analysis
timeFrame: 6 months
measure: Subgroup Analysis of Agreement
timeFrame: 6 months
Other outcomes:
measure: Safety Analyses
timeFrame: 6 months
Locations:
Study officials:
affiliation: Human Pharmacology and Physiology Lab, Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, USA
name: David B Macleod, M.B.B.S
role: PRINCIPAL_INVESTIGATOR
References: