NIBP Cuff Material Comparison Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
The purpose of the study is to compare NIBP cuff materials and their effect on the measurement results.
详细描述
Non-invasive blood pressure measurement is based on the estimation of blood pressure by using cuffs. Because the accuracy in blood pressure measurement is essential to monitor patients, the reliability of non-invasive sphygmomanometers is required by internationally recognized standards. New NIBP standard ISO 81060-2 AMD2 highlights the impact of cuff materials and construction on NIBP clinical accuracy. This study is designed to gather evidence that different cuffs provide equally comparable NIBP measurement results
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >= 18 years to 65 years
- •Are able and willing to comply with the study procedures.
- •Are able and willing to provide written informed consent to participate.
- •A cuff of same size is applicable to both arms (difference between the limbs should be less than 2cm)
- •Blood pressure needs to be measurable from both arms.
排除标准
- •Are pregnant.
- •Are breastfeeding.
- •Have participated in the study. No subject may participate more than once.
- •Have an AV fistula.
- •Have acute infection.
- •Have subject reported arrythmias.
- •PI or designee decision due to subject health conditions
结局指标
主要结局
Primary Outcome Measure
时间窗: From admission to discharge
The primary outcome is to collect NIBP measurement data from subjects in laboratory setting to show equivalency of the different NIBP Cuff.
次要结局
未报告次要终点