NCT05693168已完成不适用
Accuracy of Pulse Oximeter With Profound Hypoxia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- ARMS of SpO2 Measurements with ANNE Limb compared to SaO2
研究概览
简要总结
Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different and stable levels of SaO2 over the range of 70-100%.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is male or female, between the ages of 18 and 55 years.
- •The subject is in good general health with no evidence of any medical problems
- •The subject is fluent in both written and spoken English
- •The subject has provided informed consent and is willing to comply with the study procedures.
排除标准
- •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 has 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
- •Th subject is a current smoker
- •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 any other condition, which in the opinion of the investigators would make them unsuitable for the study
结局指标
主要结局
ARMS of SpO2 Measurements with ANNE Limb compared to SaO2
时间窗: 1 hour
Root mean square error between the function blood oxygen saturation (SpO2) provided by the device under test and the blood gas analysis of oxyhemoglobin saturation (SaO2)
次要结局
未报告次要终点
研究者
研究点 (2)
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