Calibration and Validation of the Nonin Non-invasive Cerebral Oxygen Saturation Oximeter and Cerebral Sensor in Human Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Accuracy of Sensor
研究概览
简要总结
A cerebral oximeter is a device that uses light to measure the amount of oxygen within the brain. It is similar to the device that measures the level of oxygen in the tip of the finger, known as a pulse oximeter. The cerebral oximeter consists of a sensor placed on the forehead that both emits and detects the amount of light absorbed. This study will determine how accurate the device is by comparing the displayed value on the monitor with blood samples taken simultaneously from the arterial blood in the wrist and venous blood in the neck. In order to test the device over a suitable range, the level of oxygen within the blood will be reduced in a controlled manner by reduction of the inspired oxygen concentration. This is the equivalent of ascending to an altitude of 16,000 feet. The study will be conducted in healthy volunteers.
详细描述
This is a calibration and validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation non-invasively. This is achieved by comparing NIRS-derived cerebral tissue oxygen saturation with a calculated value derived from simultaneous arterial and jugular venous blood samples.
At present the FDA have adopted the standards published in 2005 by the International Organization for Standardization (ISO), entitled ISO 9919. This is a set of technical specifications and guidelines for pulse oximeters, which share certain technical similarities to cerebral oximeters. In particular, Annex EE details the conduct of a controlled desaturation study for the calibration of pulse oximeter equipment. Specifically, the fraction of inspired oxygen delivered to test subjects is varied to achieve a series of targeted steady state saturation periods over a range of arterial oxygen saturation of 70 - 100%.
While cerebral oximeters differ from pulse oximeters in terms of the what is being measured (brain tissue v arterial blood) the FDA have maintained the requirement to examine data from human volunteer studies in which the arterial oxygen saturation ranges from 70 - 100%. Two FDA-approved cerebral oximeters were validated in a similar manner.
The device controlling the inspired gas concentration is the RespirAct, which permits precise reduction in the arterial oxygen saturation while maintaining the arterial carbon dioxide level at 40 mmHg.
The study consists of 3 sequences:
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
- 21 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21 to 35 years
- •American Society of Anesthesiologists health assessment level 1
- •Body Mass Index (BMI) 18 to 30
排除标准
- •hemoglobinopathy (e.g. sickle cell disease, thalassemia)
- •positive pregnancy test (females)
- •significant cardiac or pulmonary disease
- •history of sleep apnea
- •tobacco, drug or alcohol abuse
- •difficult airway
- •abnormal EKG / pulmonary function test / room air saturation
- •intolerance to breathing mask apparatus
结局指标
主要结局
Accuracy of Sensor
时间窗: Data collected from individual participants over 1 hour timeframe. Data from cohort of subjects collected over 6 month period.
A scatterplot is created with the forehead sensor saturation on the y-axis and the measured blood saturation on the x-axis. The line of identity is drawn representing the ideal points, meaning that the forehead sensor saturation is always the same as the blood saturation. The dispersion of the actual data points around this line of identity can be measured using a statistical calculation called Arithmetic Root Mean Square or ARMS. The smaller the ARMS the closer the data points lie around the line of identity, representing a more accurate sensor.
次要结局
未报告次要终点
研究者
David MacLeod
Assistant Clinical professor
Duke University