Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children Undergoing Cardiac Catherization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Accuracy of Sensor by Arms Calculation of Percent rSO2
研究概览
简要总结
The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.
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
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients undergoing cardiac catheterization procedure for treatment or diagnosis of cardiovascular disease
- •1 day to less than 18 years of age
- •Weight between 3.5 and 40 kg
- •Parental or legal guardian consent and subject assent
排除标准
- •Failure to obtain written consent
- •Equal or more than 18 years in age
- •Weight more than 40kg or less than 3.5kg
- •Jaundice with bilirubin levels higher than the reference range
- •Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent motioning of SpO2 levels during the study or placement of cerebral oximeter
研究组 & 干预措施
Test group
All subjects are enrolled in the test group and receive an O3 regional oximeter sensor during their scheduled, general cardiac catheterization procedure.
干预措施: O3 regional oximeter sensor (Device)
结局指标
主要结局
Accuracy of Sensor by Arms Calculation of Percent rSO2
时间窗: One visit; up to 4 hours
The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference.
次要结局
未报告次要终点