NCT04584788已完成不适用
A Single-Center, Prospective Study in Healthy Volunteers for Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2
研究概览
简要总结
Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 45 years, inclusive
- •Willing and able to provide written informed consent
- •Healthy subjects
排除标准
- •Pregnant women
- •Presence of any cardiovascular or pulmonary disease
- •Exposure to high altitude(s) (>2000 m) within 30 days prior to the study
- •Known allergy to intravenous contrast medium or heparin
- •Subject has skin abnormalities affecting the digits such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, nail polish or acrylic nails that would prevent monitoring of SpO2 levels during the study
- •Patients deemed not suitable for the study at the discretion of the Investigator
研究组 & 干预措施
Healthy Adult Volunteers
Experimental
Controlled hypoxia will be induced and Masimo O3 regional oximeter-derived tissue oxygen saturation (rSO2) readings of somatic tissue will be measured. The readings will be compared with blood reference oxygen saturation values.
干预措施: Masimo O3 Regional Oximeter (Device)
结局指标
主要结局
Accuracy of O3 Sensor by ARMS Calculation of Percent rSO2
时间窗: 1 visit up to 8 hours
Accuracy of the sensors will be determined by comparing somatic regional oxygen saturation (rSO2) readings from the O3 sensor and blood reference oxygen saturation values and calculating the Arithmetic root mean square (ARMS).
次要结局
未报告次要终点
研究者
研究点 (1)
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