Accuracy Evaluation of the Owlet OSS 3.0-M1 Sensor in Toddlers and Preschoolers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pulse rate accuracy
研究概览
简要总结
The purpose of the study is to collect information from the Owlet OSS 3.0-M1 Sensor in toddlers and preschoolers to evaluate accuracy.
详细描述
The objective of this study is to collect evidence to verify the accuracy of the Owlet OSS 3.0-M1 Sensor to measure SpO2 and pulse rate in children 19-60 months in a simulated use environment as compared to an FDA cleared reference pulse oximeter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Months 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is between 19 months and ≤ 60 months of age.
- •Subject's current body weight is ≥ 6 lbs.
- •Subject/legal guardian is fluent in both written and spoken English.
- •Subject is willing and able to follow study requirements
- •Legal guardian has provided consent.
排除标准
- •Subject has preexisting cardiovascular or respiratory disease or conditions.
- •Subjects with abnormalities (e.g., limb deformities, open wounds, severe edema) at the planned application sites that would interfere with system measurements.
- •The device(s) are unable to fit properly without risk of injury (e.g., hook of VELCRO is against the skin, wrap is too tight and constricting).
- •Subject has skin irritation at the location of device placement.
- •Subject has known allergies to adhesive.
研究组 & 干预措施
Owlet OSS 3.0-M1 Sensor
Owlet OSS 3.0-M1 Sensor accuracy evaluation compared to a reference pulse oximeter.
干预措施: Application and monitoring with an Owlet OSS 3.0-M1 Sensor (Device)
Owlet OSS 3.0-M1 Sensor
Owlet OSS 3.0-M1 Sensor accuracy evaluation compared to a reference pulse oximeter.
干预措施: Reference Pulse Oximeter (Device)
结局指标
主要结局
Pulse rate accuracy
时间窗: 2 hours
Average root mean square (ARMS) error between the pulse rate measured by the Owlet OSS 3.0-M1 vs. a reference pulse oximeter
SpO2 Accuracy
时间窗: 2 hours
The average root mean square difference between the Owlet OSS 3.0-M1 Sensor vs. readints from an FDA cleared reference pulse oximeter.
次要结局
未报告次要终点