Non-Invasive Blood Pressure Accuracy Study for Adult Subject Populations
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Collection of Non-Invasive Blood Pressures and Invasive Blood Pressures
研究概览
简要总结
The purpose of this study is developing new NIBP enhancement.
详细描述
The measurement of blood pressure is an important physiological parameter in cardiovascular health. The accurate and continuous monitoring of blood pressure assures optimal care in various clinical settings. Blood pressure can be measured both by invasive and non-invasive methods. Measurement of blood pressure via arterial cannulation is the direct invasive clinical reference method. However, because invasive blood pressure measurement requires trained clinicians and involves potential complications, non-invasive blood pressure measurement is preferred. Non-invasive method uses non-invasive sphygmomanometers.
Non-invasive blood pressure measurement is based on the estimation of blood pressure. Because the accuracy in blood pressure measurement is essential to monitor patients, the reliability of non-invasive sphygmomanometers is required by internationally recognized standards. Safety and performance of automated sphygmomanometers are complied with IEC 80601-2-30:2018 and ISO 81060-2:2018: AMD2 (approved).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age requirement: 18 and over.
- •Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 17 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm).
- •Have an arterial line as a standard of care, which measures blood pressure at the aortic root.
- •Able to provide written informed consent.
- •Expected to remain in the unit for the duration of the study procedure.
排除标准
- •Have previously participated in this study (no subject may participate more than once).
- •Pregnant and lactating women per site standard of care.
- •Subjects with peripheral arterial diseases (causing left/right arm difference).
- •Subjects with complications, who is on vasoactive agents at discretion of the PI.
- •Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning.
- •Are suffering from infection(s) or immunocompromised patients that require isolation.
- •PI or designee decision due to subject health conditions
结局指标
主要结局
Collection of Non-Invasive Blood Pressures and Invasive Blood Pressures
时间窗: From admission to discharge
The primary outcome will be the collection of blood non-invasive blood pressure measurements and invasive blood pressure measurements from adult, using NIBP Standard Parameter enhancement per ISO 81060-2 requirements. Per subject, Non-Invasive Blood Pressure and Invasive Blood Pressure endpoints are collected for: Systolic BP (mmHg) Diastolic BP (mmHg) NIBP and IBP Mean Arterial Blood Pressure (MAP)
次要结局
未报告次要终点