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临床试验/NCT04262323
NCT04262323已完成不适用

A Novel Mobile Phone Application for Blood Pressure Monitoring: A Comparison With the Oscillometric Brachial Cuff in Surgical Patients in the Postanesthesia Care Unit

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Confirmation of Blood pressure values measured simultaneously with the novel mobile phone application

研究概览

简要总结

Evaluation of a novel mobile application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) based on collected optical signals on patient's finger treated in surgical patients in the post-anesthesia care unit

详细描述

The purpose of the study is to compare the blood pressure values measured by a novel mobile phone application ( camera of the smartphone will be obstructed by the patient's right index) and the values measured by reference method used (the oscillometric brachial cuff).

All patients scheduled for noncardiac surgery at Erasme Hospital Brussels, Belgium will be recruited and their pressure will be measured with both mesurement methods. (novel smartphone application versus upper arm cuff oscillometry) at 5 time points (each 20-30 minutes)

The OptiBP Application is a mobile application installed on a mobile phone which is a non-invasive data-logger intended to acquire physiological data from patients. By applying the patient's finger on a smartphone's camera, a movie is generated and transformed into values of diastolic, mean and systolic blood pressure.

Three measures will be taken (spaced by one minute) with both methods after a period of 3 minutes of rest at each time point.

The patient's blood pressure will be measured in parallel with the mobile application and with the reference equipment (the oscillometric brachial cuff).

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (Men or women) older than 18 years old scheduled for a noncardiac surgery and admiited in the post-anesthesia care unit after the surgery
  • Informed Consent as documented by signature (signed before surgery)

排除标准

  • Minor patients
  • Patients unable to participate due to the illness.
  • Patients that cannot sign informed consent
  • Blood pressure difference between the two arms of more than10mmHg inter-arm difference)

结局指标

主要结局

Confirmation of Blood pressure values measured simultaneously with the novel mobile phone application

时间窗: up to 2 hours

Comparison of values to non-invasive reference method (the oscillometric brachial cuff )

次要结局

未报告次要终点

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Joosten, MD PhD

Principal Investigator

Erasme University Hospital

研究点 (1)

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