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临床试验/NCT03919136
NCT03919136Unknown不适用

Accuracy of Non-Invasive Non-Oscillometric Blood Pressure Wrist Worn Measurement

LiveMetric S.A.3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
3
主要终点
Non-Oscillometric Blood Pressure Wrist Worn Data Acquisition and Analysis

研究概览

简要总结

In this study, the investigators are testing the accuracy of a wrist-worn measurement device by comparing its blood pressure measurement to arterial line (A-line) blood pressure monitors. The device is similar in style and fit to popular activity bands, but it is unique in that it measures blood pressure.

详细描述

LiveMetric has developed a wrist-worn measurement device intended for use as a standalone device, designed for measurement of intermittent blood pressure for individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance.

The wrist-worn measurement device is intended to be worn on the wrist for intermittent measurements of Blood pressure.

The use does not require any special action from the user apart from wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet all the time or most of the time.

The study will include subjects that are hospitalized in the ICU and/or any of the cardiology departments or affiliating units such as Cath lab, heart transplant unit, etc..) and are continually monitored by an intra-arterial blood pressure line (A-line). A medical professional will measure simultaneous non-invasive auscultatory readings to determine the lateral difference for later adjustment of calculation. A medical professional or a company representative accompanied by a medical professional will place the device on the opposite limb than the one having the A-line, providing the location of the placement has intact skin. During the measurement stage, BP values are simultaneously recorded from the reference invasive A-line and the wrist worn device.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Patients who have a pre-existing intra-arterial blood pressure (A-Line) line for standard care
  • Patients that are ≥18 years of age.

排除标准

  • Body habitus that precludes patients from wearing a device on their wrist
  • Subjects without normal palpable radial artery pulse, whether congenital, due to medical intervention, or otherwise
  • Subjects with wrist circumference less than 155mm or greater than 210mm
  • Subjects implanted with pacemaker, VAD's or other mechanical circulatory support device whether intracorporeal or extracorporeal
  • Patients that do not have an intra-arterial blood pressure line.

结局指标

主要结局

Non-Oscillometric Blood Pressure Wrist Worn Data Acquisition and Analysis

时间窗: 2 years

Measurements including systolic and diastolic pressures will be assessed and analyzed retrospectively according to the requirements of the standard (ISO 81060-2).

次要结局

未报告次要终点

研究者

发起方
LiveMetric S.A.
申办方类型
Other
责任方
Sponsor

研究点 (3)

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