NCT06460246已完成不适用
Pulse Oximeter Accuracy During Stable Hypoxia Plateaus
Acurable Ltd.2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年6月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.
研究概览
简要总结
This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%.
详细描述
This project aims to test the accuracy of pulse oximeters in the range of arterial HbO2 saturations from 100% down to 70%. This is done by comparing the pulse oximeter reading during brief, steady state hypoxia plateaus with a gold-standard measurement of blood oxyhaemoglobin 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
- •Male or female, aged >= 18 and <
- •Subject in good general health with no evidence of any medical problems.
- •Subject is fluent in both written and spoken English.
- •Subject has provided informed consent and is willing to comply with the study procedures.
排除标准
- •Subject is obese (BMI > 35).
- •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.
- •Subject has hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
- •Subject has any other serious systemic illness.
- •Subject is a current smoker.
- •Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
- •Subject has a history of fainting or vasovagal response.
- •Subject has a history of sensitivity to local anesthesia.
- •Subject has a diagnosis of Raynaud's disease.
- •Subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
- •Subject is pregnant, lactating, or trying to get pregnant.
- •Subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
- •Subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.
结局指标
主要结局
Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.
时间窗: 1-4 hours
Performance of the pulse oximeters against corresponding arterial blood oxygen saturation.
次要结局
未报告次要终点
研究者
研究点 (2)
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