NCT03348189已完成不适用
SpO2 Hypoxia Accuracy Validation Study
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
- 1
- 主要终点
- SpO2 Hypoxia Accuracy Validation Study
研究概览
简要总结
The primary objective of this study is to evaluate the % oxygen saturation by pulse oximetry accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.
详细描述
The primary objective of this study is to evaluate the %SpO2 accuracy of a combined pulse oximetry system which consists of a Nonin sensor ), an adaptor cable, and an oximetry system during non-motion conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 50 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 50 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, is actively trying to get pregnant, or who has a positive urine pregnancy test on the day of the study
- •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
SpO2 Hypoxia Accuracy Validation Study
时间窗: Through study completion, 3 months average
Values from the test device will be compared to the values from co-oximetry to determine accuracy of the test device.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Polso SpO2 Accuracy Validation StudyHypoxiaNCT03735329ChroniSense Medical Ltd.10
招募中
不适用
Accuracy of Pulse Oximeters During Profound HypoxiaHypoxiaNCT05790616Philips Clinical & Medical Affairs Global66
已完成
不适用
Controlled Desaturation Study for TipTraQ SpO2 Performance ValidationHypoxiaNCT06634693PranaQ Pte. Ltd.12
撤回
不适用
Accuracy Validation of a Pulse Oximetry MonitorHealthyNCT02506010Medtronic - MITG
已完成
不适用
Pulse Oximeter Accuracy During Stable Hypoxia PlateausHealthyNCT06460246Acurable Ltd.12