Plethysmographic and Acoustic Respiration Rate Clinical Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Collection of high-resolution pulse oximetry and RAM data in pediatric subjects
研究概览
简要总结
The objective of this clinical investigation is to collect high-resolution pulse oximetry, RRp, and RAM data in pediatric subjects for the purpose of algorithm optimization and to build a database of representative pulse oximetry and respiratory signal profiles for patients in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 0 to 5 years old
- •Fully developed skin
排除标准
- •Subjects with skin abnormalities at the planned application sites that would interfere with sensor application.
- •Subjects with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
- •Subjects deemed not suitable for the study at the discretion of the investigator
研究组 & 干预措施
Test Group
The subjects will be enrolled in the test group and will receive Pulse Oximeter with respiration rate sensor to examine the respiration rate.
干预措施: Pulse Oximeter with respiration rate sensor (Device)
结局指标
主要结局
Collection of high-resolution pulse oximetry and RAM data in pediatric subjects
时间窗: through study completion, an average of 6 months
The objective of this clinical investigation is to collect high-resolution pulse oximetry and acoustic signals in pediatric subjects for the purpose of algorithm optimization and to build a database of representative pulse oximetry and respiratory signal profiles for patients in this population.
次要结局
未报告次要终点