NCT05920278已完成不适用
Performance of the Movano Health Ring in a Controlled Hypoxia Study: Prospective Observational Study
Movano Health1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2022年10月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- RMSE compared to arterial blood SaO2
研究概览
简要总结
The goal of this study was to evaluate the accuracy of pulse oximeters over the range of 70-100%. Two devices were placed on each subject with one on the finger and the other on the fingertip. SpO2 measurements from these devices were compared to sampling of arterial blood during brief stable oxygen desaturation in healthy volunteers to evaluate the claimed range.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject is in good general health with no evidence of any medical problems.
- •Subject is fluent in both written and spoken English.
- •Subject provided written informed consent and is willing to comply with the study procedures.
- •Subject is willing to have their skin color assessed.
排除标准
- •Subject is obese with a BMI over
- •Subject has a known history of heart disease, lung disease, kidney or liver disease.
- •Subject has asthma, sleep apnea, or uses a CPAP.
- •Subject has diabetes.
- •Subject has a clotting disorder, anemia, or in the opinion of the investigator, they would be unsuitable for participation.
- •Subject has any other serious system illness.
- •Subject is a current smoker.
- •Subject has any injury, deformity, or abnormality at the sensor sites that, in the opinion of the investigator, would interfere with the sensors working correctly.
- •Subject has a history of fainting or vasovagal response.
- •Subject has a sensitivity to local anesthesia.
- •Subject has Raynaud's disease.
- •Subject has unacceptable collateral circulation based on an exam by the investigator.
- •Subject is pregnant, lactating, or trying to get pregnant.
- •Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study procedures.
- •Subject has any other condition, which in the opinion of the investigator, would make them unsuitable for the study.
结局指标
主要结局
RMSE compared to arterial blood SaO2
时间窗: 2 days
Root Mean Squared Error between Movano Ring SpO2 measurement and the arterial blood SaO2 calibrated using arterial blood gas.
次要结局
未报告次要终点
研究者
研究点 (1)
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