NCT03124927已完成不适用
Accuracy of Methemoglobin Measurement for Rainbow DCI Sensors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Accuracy of Sensor by Arms Calculation
研究概览
简要总结
In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet measurement by a DCI pulse oximeter sensor will be assessed by comparison to blood measurements from a laboratory analyzer.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must understand and consent to be in the study
- •American Society of Anesthesiology Class I (Healthy subjects without any systemic disease at all).
排除标准
- •Subjects who have any systemic disease at all.
- •Subjects who do not understand the study and the risks involved.
- •Current smokers.
- •Subjects who are pregnant.
结局指标
主要结局
Accuracy of Sensor by Arms Calculation
时间窗: 5 hours
Accuracy will be determined by comparing the noninvasive blood methemoglobin measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.
次要结局
未报告次要终点
研究者
研究点 (4)
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