Accuracy of Pulse Oximeters With Profound Hypoxia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- SpO2 Accuracy
研究概览
简要总结
The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the the subject device during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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, aged ≥18 and <
- •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
- •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.
- •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
SpO2 Accuracy
时间窗: Through study completion, 3 months average
SpO2 as measured by the subject device during periods of low motion will be compared to the oxyhemoglobin saturation (SaO2) as measured by direct oximetry with a Radiometer ABL-90 multi-wavelength oximeter
次要结局
未报告次要终点