NCT05926648已完成不适用
Form, Fit, and Function of INVSENSOR00061
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- INVSENSOR00061 SpO2 Accuracy
研究概览
简要总结
The objective of this study is to evaluate the form, fit, and function of INVSENSOR00061 when used on newborn and infant subjects 0-18 months.
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
- 0 Months 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) - up to 18 months of age.
- •The parent(s) or guardian(s) of minor subjects are able to read and communicate in English and understand the study and the risks involved.
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 has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
研究组 & 干预措施
Test Subjects
Experimental
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVENSOR00061
干预措施: INVSENSOR00061 (Device)
结局指标
主要结局
INVSENSOR00061 SpO2 Accuracy
时间窗: 2 hours
The SpO2 accuracy of INVSENSOR00061 was determined by calculating the accuracy root mean squared (Arms) difference between the measured values (SpO2i) to the reference values (SpO2ref\_i) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SpO2ref\_i )\^2 ))/n
次要结局
未报告次要终点
研究者
研究点 (1)
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