Accuracy Validation in Multiple SpO2 Systems
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Completion of study by all subjects
研究概览
简要总结
The purpose of this study is to evaluate the SpO2 accuracy and performance of multiple pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation.
This study is observational in nature which quantifies device performance and accuracy in comparison to a Reference Standard.
详细描述
The purpose of this study is to evaluate the SpO2 accuracy and performance of pulse oximeters during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry for SpO2 validation. The end goal is to show the SpO2 accuracy performance of the pulse oximeters. It is expected that the Accuracy Root Mean Square (Arms) performance of pulse oximeters will meet a specification of 3 or better in non-motion conditions for the range of 70-100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •healthy individuals between the age of 18-50 years.
排除标准
- •Clotting disorders, diabetes, currently taking psychotropic medications.
结局指标
主要结局
Completion of study by all subjects
时间窗: 5 years
次要结局
未报告次要终点
研究者
David Ransom, MD
Primary Investigator, Clinimark
Clinimark, LLC