SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- SpO2 Accuracy of INVSENSOR00061
研究概览
简要总结
This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.
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
- 37 Weeks 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Subject is a full-term newborn (37 weeks) to 18 months of age.
排除标准
- •• Subject has underdeveloped skin.
- •Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements.
- •Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
- •Subject is not suitable for the investigation at the discretion of the Investigator.
结局指标
主要结局
SpO2 Accuracy of INVSENSOR00061
时间窗: Approximately 15 minutes
SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor.
Pulse Rate Accuracy of INVSENSOR00061
时间窗: Approximately 15 minutes
Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute.
次要结局
未报告次要终点