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临床试验/NCT02823873
NCT02823873撤回不适用

Validation of Pulsewave Oscillometric Wrist Cuff Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women

University of Arkansas1 个研究点 分布在 1 个国家开始时间: 2016年7月最近更新:
适应症

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.

  1. The armpit will be measured as proximally as possible.
  2. The mid upper arm will be recorded by measuring at the halfway point between the acromion and the olecranon process.
  3. The distal upper arm measurement will be taken approximately 2 cm proximal to the antecubital crease.
  4. 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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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