Multiparameter Monitor Non-Invasive Blood Pressure Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor.
研究概览
简要总结
The primary objective of the study is to demonstrate the accuracy in healthy adults with Vital USA Device by comparison to a non-invasive (auscultatory) reference sphygmomanometer.
The procedure, data collection methods and data analysis that are outlined in the protocol follow the standard: International Standards Organization (ISO) 81060-2:2018 Non-invasive Sphygmomanometers - Part 2: Clinical validation of automated measurement type.
详细描述
This study will include up to 100 adults ≥ 18 years of age. The final subject database will contain no fewer than 85 subjects with a minimum of 255 paired observations. At least 90% of the subjects will contribute 3 paired observations, if necessary the balance of the data will be added from additional subjects.
An interim analysis will be conducted at the end of Part 1 data collection and will consist of simple statistics that will compare the test device tot he reference cuff non-invasive (auscultatory) reference sphygmomanometer.
Part 2 data collection will be conducted after Part 1 data collection interim report is reviewed and additional data collection is approved by the client. It will test an additional 55 subjects (plus extra subjects as replacements if necessary).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be able to provide an informed consent or have legally authorized representative consent to participate.
- •Subject must be willing and able to comply with the study procedures.
- •Subject must be ≥ 18
- •Subject or legally authorized representative must be able to read or write in English.
- •Subjects with a finger circumference < 8.3 cm.in the range of 10-25 mm
- •At least 30% of subjects shall be male and at least 30% of subjects shall be female
排除标准
- •Lack of Informed consent.
- •Subjects with deformities or abnormalities that may prevent proper application of the device under test.
- •Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
- •Subjects with known heart dysrhythmias
- •Subjects with compromised circulation or peripheral vascular disease.
- •Subjects with clotting disorders or taking prescribed blood thinners.
- •Subjects that cannot tolerate sitting for up to 1 hour.
- •Subject with a blood pressure demographic that has already been filled
结局指标
主要结局
Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor.
时间窗: 1 Hour
The primary objective of this study is to provide a validation for non-invasive blood pressure measurement accuracy for the Vital Detect blood pressure monitor when compared to the Reference Sphygmomanometer. Data taken was based on dual observers (Criterion 1(C1), Criterion 2 (C2) for both Systolic and Diastolic determinations. Since the same arm sequential method was used, data for a given subject were averaged to create the reference blood pressure determination against the acceptance criteria. The device under test (DUT) passed or failed the determination based on the mean error and standard deviation of the determination. The acceptance criteria: Criterion 1: Mean Error Standard Deviation (Systolic / Diastolic) (Systolic / Diastolic) \</= 5.0 mmHg \</= 8.0 mmHg Criterion 2: Standard Deviation (Systolic) (Diastolic) \</= 5.33 mmHg \</= 6.09 mmHg
次要结局
未报告次要终点