NCT06120777已完成不适用
Clinical Validation for SpO2 Function of Masimo INVSENSOR00069
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- SpO2 Accuracy of Masimo INVSENSOR00069
研究概览
简要总结
Assess the accuracy of INVSENSOR00069's peripheral oxygen saturation (SpO2) against contemporaneous measurement from arterial blood gas (ABG) analysis.
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
- •Influenced by study design:
- •Subject is 18 to 50 years of age.
- •Subject weighs a minimum of 110 lbs.
- •Hemoglobin value ≥ 11 g/dL.
- •Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
- •Systolic blood pressure ≤ 140 mmHg and ≥ 90 mmHg and diastolic blood pressure ≤ 90 mmHg and ≥ 50 mmHg. If systolic blood pressure is lower than 100 mmHg and/or diastolic blood pressure is lower than 60 mmHg, subject passes an orthostatic blood pressure test.
- •CO value ≤ 3.0% FCOHb.
- •Subject is comfortable to read and communicate in English*. *This is to ensure the subject can provide informed consent (as study materials are currently available in English only) and can comply with study procedures.
排除标准
- •Influenced by device warning labels:
- •Subjects with a skin condition affecting the digits, where the sensor is applied, which would interfere with the path of light (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
- •Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them.
- •Subject has hemoglobinopathies or synthesis disorders (e.g., thalassemia, sickle cell disease).
- •Subject has a peripheral vascular or vasospastic disease (e.g., Raynaud's disease).
- •Influenced by study design/environment:
- •Subjects who do not pass the health assessment for safe participation in the study procedures.
- •Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist.
结局指标
主要结局
SpO2 Accuracy of Masimo INVSENSOR00069
时间窗: 1-3 hours
The SpO2 accuracy of Masimo INVSENSOR00069 was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SaO2\_i )\^2 ))/n.
次要结局
未报告次要终点
研究者
研究点 (2)
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