Accuracy of Pulse Oximeters With Profound Hypoxia - Test Protocol
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
- Accuracy of pulse oximeter with profound hypoxia
研究概览
简要总结
This project aims to test the accuracy of pulse oximeters during mild, moderate, and severe hypoxia, i.e., a range of arterial HbO2 saturation from 100 down to 70%. A typical study will include at least ten subjects (at least 200 necessary data points to meet the ISO 80601-2-61:2017).
详细描述
After local anesthetic injection, a 22-gauge catheter is inserted in one radial artery. Pulse oximeters are attached to fingers, ears, or flat body surfaces. Subjects are in a comfortable semi-recumbent position. Subjects then breathe air mixtures containing reduced amounts of oxygen to produce the desired level of hypoxemia. Stable, safe, and controlled hypoxia is breath-by-breath by breath respiratory gas analysis and a computer program that permits the inspired gas mixture to be adjusted to achieve a level of lung alveolar gas that will achieve the desired degree of saturation.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is male or female, aged ≥18 and <
- •The subject is in good general health with no evidence of any medical problems.
- •The subject is fluent in both written and spoken English.
- •The subject has provided informed consent and is willing to comply with the study procedures.
排除标准
- •The subject is obese (BMI>30).
- •The subject has a known history of heart disease, lung disease, kidney or liver disease.
- •Diagnosis of asthma, sleep apnea, or use of CPAP.
- •Subject has diabetes.
- •Subject has a clotting disorder.
研究组 & 干预措施
Single
Subjects undergo an interventional procedure and non-invasive measurements of SpO2.
干预措施: A-line (Procedure)
结局指标
主要结局
Accuracy of pulse oximeter with profound hypoxia
时间窗: 2 days
Perform accurate measurement of a range of arterial HbO2 saturation from 100 to down to 70% during mild, moderate, and severe hypoxia.
次要结局
未报告次要终点