Optical Brain Pulse Monitor: Validation Of Cerebral Oximetry Monitoring (OBPM: VOCOM) Study.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 65
- 主要终点
- Accuracy by Average Root Mean Squared Error
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Accuracy by Average Root Mean Squared Error
时间窗: 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
时间窗: 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
次要结局
- Concordance Correlation Coefficient(6 months)
- Passing-Bablok Regression Analysis(6 months)
- Linear Mixed Model Regression Analysis(6 months)
- Subgroup Analysis of Agreement(6 months)
研究者
Elliot Teo
Clinical Research Manager
Cyban Pty Ltd