NCT06334055已完成不适用
Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073
研究概览
简要总结
The aim of the study is to validate the Mean Arterial Pressure (MAP) parameter of Masimo INVSENSOR00073 against the gold standard blood pressure measurements from the arterial line while subject undergo a blood pressure variation procedure.
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 40 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 40 years of age.
- •Subject weighs a minimum of 110 lbs.
- •Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
- •Baseline blood pressure:
- •Systolic blood pressure ≤ 135 mmHg and ≥ 100 mmHg.
- •Diastolic blood pressure ≤ 95 mmHg and ≥ 55 mmHg.
- •Valid systolic blood pressure (SBP) auscultatory measurements for lateral difference is ≤ 15 mmHg.
- •Valid diastolic blood pressure (DBP) auscultatory measurements for lateral difference is ≤ 10 mmHg.
- •Hemoglobin value ≥ 11 g/dL.
- •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:
- •Subject is pregnant or breastfeeding.
- •Subject is experiencing dysrhythmia or arrhythmia.
- •Influenced by study design/environment:
- •Subject is concurrently participating in another research study.
- •Subjects not suitable for the investigation at the discretion of the clinical team including but not limited to the items below.
- •Subjects who do not pass the health assessment for safe participation in the study procedures.
- •Inability to insert or difficulty with 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
Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073
时间窗: 1-5 hours.
Accuracy and precision of mean arterial pressure (MAP) measured by Masimo INVSENSOR00073 in comparison to radial arterial line.
次要结局
未报告次要终点
研究者
研究点 (2)
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