NCT06022523招募中不适用
Accuracy of Pulse Oximeters With Profound Hypoxia
Consolidated Research, Inc.2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Saturation level measurement
研究概览
简要总结
The goal of this clinical trial is the acquisition of photoplethysmography signals during periods of profound hypoxia. The study is designed in accordance with ISO 80601- 2-61,2ed:2017-12 & 2018-02.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Pregnancy -
研究组 & 干预措施
Acquisition
Experimental
Subjects will undergo profound hypoxia with stable plateaus.
干预措施: Data acquisition using DT-400 pulse oximetry system (Diagnostic Test)
结局指标
主要结局
Saturation level measurement
时间窗: Within 12 months of subject recruitment
Induction of hypoxia by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide to allow measurement of oxyhemoglobin saturation between 70-100%. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable
次要结局
未报告次要终点
研究者
研究点 (2)
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