Feasibility and Performance Evaluation of INVSENSOR00024
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation
研究概览
简要总结
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.
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 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Less than or equal to 1 month of age
- •Weight <3kg
- •Subjects admitted with standard of care (SOC) arterial blood sampling line already in place
排除标准
- •Subjects with underdeveloped skin
- •Subjects with abnormalities at the planned application sites that would interfere with system measurements
- •Subjects with known allergic reactions to foam/rubber products and adhesive tape
- •Deformities of limbs, absence of feet, sever edema, and other at the discretion of the Principal Investigator
研究组 & 干预措施
RD SET Neo SpO2
All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2.
干预措施: RD SET Neo SpO2 (Device)
结局指标
主要结局
Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation
时间窗: up to 8 hours
Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, 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