NCT02475668已完成不适用
SpO2 Accuracy Validation of Pulse Oximetry Systems During Motion and Non-Motion Conditions of Induced Hypoxia as Compared to Arterial Blood CO-Oximetry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion
研究概览
简要总结
Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems.
详细描述
Study to evaluate the %SpO2 accuracy performance of the Nonin Medical pulse oximetry systems during motion and non-motion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is male or female
- •The subject is of any racial or ethnic group
- •The subject is > 30 kg (>66 pounds) in weight (self-reported)
- •The subject has at least one finger height of 0.2 - 1.0 inch (based on measurement)
- •The subject is between 18 years and 45 years of age (self=reported)
- •The subject shows no evidence of medical problems as indicated by satisfactory completion of the health assessment form
- •The subject has given written informed consent to participate in the study
- •The subject is both willing and able to comply with study procedures.
排除标准
- •The subject has a BMI greater than 31 (based on weight and height)
- •The subject has had any relevant injury at the sensor location site (self-reported)
- •The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination)
- •The subject is current smoker (self-reported)
- •The subject has a known respiratory condition (self-reported)
- •The subject has a known heart or cardiovascular condition (self-reported)
- •The subject is currently pregnant (self-reported)
- •The subject is actively trying to get pregnant (self-reported)
- •The subject has a clotting disorder (self-reported)
- •The subject has Raynaud's Disease (self-reported)
- •The subject is known to have a hemoglobinopathy (self-reported)
- •The subject is on blood thinners or medication with aspirin (self-reported)
- •The subject has unacceptable collateral circulation from the ulnar artery (based on examination)
- •The subject is unwilling or unable to provide written informed consent to participate in the study
- •The subject is unwilling or unable to comply with the study procedures
- •The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.
结局指标
主要结局
accuracy value (Arms) for %SpO2 over the range of 70-100% in motion and non-motion
时间窗: 3 days
次要结局
未报告次要终点
研究者
研究点 (1)
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