Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of Participants With rSO2 Collected
研究概览
简要总结
The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data collected from the cutaneously placed forehead sensors. Due to the design of the systems, the devices will be used serially instead of concurrently. Because of this timing, changes in patient state may not be reflected in measurements collected by both devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Less than 10 kg
- •Subjects less than or equal to 28 days old
排除标准
- •Underdeveloped skin at sites of sensor placement
- •Jaundice or bilirubin levels out of normal range
- •Subject has skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, or substantial skin breakdown that would prevent monitoring of oxygenation levels during the study
- •Subject deemed not eligible based on Principal Investigator's judgment
研究组 & 干预措施
Neonatal Test group
Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.
干预措施: Masimo O3 Neonatal Sensors (Device)
Neonatal Test group
Subjects will receive a Masimo O3 Neonatal sensors as well as a 510(k) cleared sensor.
干预措施: 510(k) cleared sensor (Device)
结局指标
主要结局
Number of Participants With rSO2 Collected
时间窗: Data collection period; alternating sensors every 5 minutes for up to 20 minutes.
In order to obtain the RMS value, rSO2 values collected from the control device (510(k) cleared regional oximetry sensor) is subtracted from the rSO2 values collected from the investigational device (Masimo O3 neonatal sensors) for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value.
次要结局
未报告次要终点