NCT01183338撤回不适用
SpO2 Accuracy Validation of Sotera Wireless Pulse Oximetry Systems During Non-Motion and 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
- 撤回
- 入组人数
- 15
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to standard devices in estimating the level of blood oxygen (SpO2) in adult human subjects.
详细描述
This study is a single-center blinded study that will enroll up to 15 adult subjects, male or female, of any ethnic background.
SpO2 and pulse rate measurements reported by ViSi will be compared with simultaneous measurements of blood SaO2 and pulse rate made by an FDA-cleared CO-oximeter and pulse oximeter, respectively. The paired measurements will be made in a well-controlled environment under optimal laboratory conditions.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 18 years of age.
- •Subject is a healthy volunteer capable of undergoing controlled hypoxemia to the level of 70% SaO2 (±3%) with no or minimal medical risk.
- •Subject is willing and able to participate in the measurement period for up to two hours.
排除标准
- •Subject has a carboxyhemoglobin level (COHb) ≥3%.
- •Subject has a MetHb level ≥2%.
- •Subject has a ctHb value ≤10g/dl.
- •Subject is in another clinical study that may interfere with the results of this study.
- •Subject is unable or unwilling to have a blood gas and oxygen saturation measurements taken from either wrist/hand.
- •Subject is deemed by the Investigator to be medically unsuitable for participation in this study.
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Accuracy of Non-Invasive Blood Pressure Measurement in AdultsHypertensionHypotensionNCT01183741Sotera Wireless, Inc.150
已完成
不适用
SpO2 Accuracy of Noninvasive Pulse Oximeter SensorHealthyHypoxiaNCT05141500Stryker Sustainability Solutions12
撤回
不适用
Accuracy Validation of a Pulse Oximetry MonitorHealthyNCT02506010Medtronic - MITG
已完成
不适用
Polso SpO2 Accuracy Validation StudyHypoxiaNCT03735329ChroniSense Medical Ltd.10
已完成
不适用
Accuracy of Pulse Oximeters With Profound Hypoxia During MotionHypoxiaNCT04814342Nihon Kohden5