Optical Brain Pulse Monitor: Validation of Cerebral Oximetry Monitoring (OBPM:VOCOM) Study.
- Conditions
- Hypoxia
- Registration Number
- NCT06657820
- Lead Sponsor
- Elliot Teo
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 65
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Accuracy by Average Root Mean Squared Error 6 months 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
Bland-Altman Agreement Analysis 6 months 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
- Secondary Outcome Measures
Name Time Method Concordance Correlation Coefficient 6 months 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.
Passing-Bablok Regression Analysis 6 months 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.
Linear Mixed Model Regression Analysis 6 months 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.
Subgroup Analysis of Agreement 6 months 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