SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- It Was Expected That the Accuracy Root Mean Square (ARMS) Between Measured SpO2 of Owlet Smart Sock V2 v1.1 and Reference SpO2 Would Meet the Required Specification of ARMS 3% or Lower in Non-motion Conditions for the Range of 70 - 100%
研究概览
简要总结
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. There are two devices used in this investigational study: BabySat v.1.0 and Owlet Baby Care, Inc. Smart SockTM 2 (currently available over-the-counter), with specific emphasis on its pulse oximetry accuracy. The BabySat and Smart SockTM 2 are non-invasive home care devices for use with infants. The purpose of this study was to validate the SpO2 accuracy of BabySat v1.0 and Owlet Smart SockTM 2, OSS v1.1 sensors pulse oximetry, during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry.
详细描述
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. A pulse oximeter is a device that measures the oxygen saturation of arterial blood non-invasively.
The purpose of this study was to evaluate the SpO2 accuracy performance of the Owlet BabySat v1.0 and Smart SockTM 2 pulse oximetry OSS v1.1 sensors during non-motion conditions over the range of 70-100% SaO2 to arterial blood samples assessed by CO-Oximetry for a SpO2 validation.
The goal, in its entirety, was to show the SpO2 accuracy performance for the investigational device Owlet Baby Care, Inc. Smart SockTM V. 2.
It was expected that the Accuracy Root Mean Square (ARMS) performance would meet the required specification of ARMS 3% or lower in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification.
No risks or adverse device effects were expected. There were no contraindications for use in the proposed study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance, made up of either.
- •Subject must have the ability to understand and provide written informed consent
- •Subject is 18 to 50 years of age
- •At least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger
- •Subject must be willing and able to comply with study procedures and duration
- •Subject is a non-smoker or who have not smoked within 2 days prior to the study.
排除标准
- •Subject is considered as being morbidly obese (defined as BMI >39.5)
- •Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study
- •Females who are pregnant, who are trying to get pregnant
- •Smoker Subjects who have refrained will be screened for COHb levels
- •Subjects with known heart or cardiovascular conditions
- •Subjects with known clotting disorders
研究组 & 干预措施
Reference CO-Oximetry
Reference Co-Oximetry
干预措施: Pulse oximetry with Owlet BabySat v1.0 sensor (Diagnostic Test)
Owlet BabySat v1.0
Owlet BabySat v1.0
干预措施: Pulse oximetry with Owlet BabySat v1.0 sensor (Diagnostic Test)
Owlet Smart Sock V2 v1.1
Owlet Smart SockTM 2 , OSS v1.1 Sensor and Custom Adult Thumb Sock
干预措施: Pulse oximetry with Owlet BabySat v1.0 sensor (Diagnostic Test)
结局指标
主要结局
It Was Expected That the Accuracy Root Mean Square (ARMS) Between Measured SpO2 of Owlet Smart Sock V2 v1.1 and Reference SpO2 Would Meet the Required Specification of ARMS 3% or Lower in Non-motion Conditions for the Range of 70 - 100%
时间窗: Acute immediate assessment of the sensor accuracy compared to CO-oximetry
The purpose of the study was to evaluate the accuracy of the blood oxygen saturation (SpO2) at rest over the range of 70-100% compared to arterial blood samples assessed by standard methods \[Co-Oximetry\]. A standard pulse oximeter accuracy is evaluated by the Accuracy Root Mean Square (ARMS). The results of accurate performance of the oximetry system require ARMS of 3% or less in non-motion conditions for the range of 70-100% SpO2 per standard.
次要结局
未报告次要终点