Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Withings
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- RMSE compared to CO-oximetry
研究概览
简要总结
Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained. The blood sample is analyzed for oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the latest ISO and FDA guidance documents for pulse oximeter testing.
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
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is male or female, aged ≥18 and <
- •The subject is in good general health with no evidence of any medical problems.
- •The subject has both wrist circumferences between 14 and 22cm.
- •The subject has provided informed consent and is willing to comply with the study procedures.
排除标准
- •The subject is obese (BMI>30).
- •The subject has a known history of heart disease, lung disease, kidney or liver disease.
- •Diagnosis of asthma, sleep apnea, or use of CPAP.
- •Subject has diabetes.
- •Subject has a clotting disorder.
- •The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample that in the opinion of the investigator, would make them unsuitable for study participation.
- •The subject has any other serious systemic illness.
- •The subject is a current smoker.
- •The subject has piercings that may cause air leaks during the test
- •The subject has any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
- •The subject has a history of fainting or vasovagal response.
- •The subject has a history of sensitivity to local anesthesia.
- •The subject has a diagnosis of Raynaud's disease.
- •The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
- •The subject is pregnant, lactating or trying to get pregnant.
- •The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
- •The subject has a resting heartrate over 120, Systolic BP is over 150, diastolic BP is over 90 or room air SpO2 is less than 94%.
- •The subject has carboxyhemoglobin over 3% as measured by Lab blood gas analysis.
- •The subject has any other condition, which in the opinion of the investigators' would make them unsuitable to participate.
研究组 & 干预措施
profound hypoxia
干预措施: hypoxia (Diagnostic Test)
结局指标
主要结局
RMSE compared to CO-oximetry
时间窗: 1 hour
Root Mean Squared Error between the functional blood oxygen saturation (SpO2) provided by the device under test and the arterial blood oxygen measured with the CO-oximeter.
RMSE Compared to CO-oximetry
时间窗: 1 hour
Root Mean Squared Error between the functional blood oxygen saturation (SpO2) provided by the device under test and the arterial blood oxygen measured with the CO-oximeter.
次要结局
未报告次要终点