Validation of Pulsewave Oscillometric Wrist Cuff Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proportion of measurements by Pulsewave cuff that are within 5 mmHg of standard clinical measurements
研究概览
简要总结
The purpose of this study is to test the accuracy of the Pulsewave wrist blood pressure cuff in pregnant and postpartum women who have either normal blood pressure or high blood pressure.
详细描述
The study will include a series of nine blood pressure measurements. The measurements will alternate between a gold standard auscultatory blood pressure measurement and the Pulsewave monitor.
A trained clinician will be used for gold standard measurements using an appropriately sized cuff around the upper arm, a sphygmomanometer, and a stethoscope. Systolic blood pressure is defined by the first Korotkoff sound; diastolic blood pressure is defined by the fifth Korotkoff sound.
Measurements by the Pulsewave monitor will be performed using a proprietary oscillometric wrist cuff automated by a computer tablet and software made by CloudDx Inc.
Women will be seated for 5 to 10 minutes before the first blood pressure measurement. During this time, 4 circumference measurements will be taken of the arm and wrist.
- The armpit will be measured as proximally as possible.
- The mid upper arm will be recorded by measuring at the halfway point between the acromion and the olecranon process.
- The distal upper arm measurement will be taken approximately 2 cm proximal to the antecubital crease.
- The wrist will be measured approximately 2 cm proximal to the wrist flexion crease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant or admitted to the postpartum unit
- •Normotensive women - No diagnosis of hypertension
- •Hypertensive women - Diagnosis of hypertensive disorder of pregnancy
排除标准
- •Women in active labor
- •Women < 18 years of age
- •Non-english speakers
结局指标
主要结局
Proportion of measurements by Pulsewave cuff that are within 5 mmHg of standard clinical measurements
时间窗: Immediately after blood pressure measurement
Test measurement will be compared to standard measurements made at the same time.
次要结局
未报告次要终点
