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临床试验/NCT04121624
NCT04121624已完成不适用

A New Mobile Phone Application for Blood Pressure Monitoring: A Comparison With the Oscillometric Brachial Cuff in Patients Treated in The Emergency Department

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2019年10月7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
110
试验地点
1
主要终点
Confirmation of Blood pressure values measured simultanuously with the novel smartphone application

研究概览

简要总结

Evaluation of a novel smartphone application designed to estimate blood pressure (systolic-diastolic and mean arterial pressure) and heart rate based on collected optical signals on patient's finger treated in the emergency department against the reference method (the oscillometric brachial cuff )

详细描述

The purpose of the study is to compare the blood pressure values measured by a novel smartphone 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 admitted to the emergency department at Erasme Hospital Brussels, Belgium during 5 consecutive weeks will be recruited and their pressure will be measured with both mesurement methods. (novel smartphone application versus upper arm cuff oscillometry).

The OptiBP Application is a mobile application installed on a smartphone 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 (+ heart rate), as well as patient's heart rate.

After having compared that the blood pressure in both arms are similar ( maximum of 10 mmHg of blood pressure difference between both arms), three measures will be taken (spaced by one minute) with both methods after a period of 3 minutes of rest (supine position).

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 admitted to the emergency department and in relatively good conditions to be able to participate in the study.
  • Informed Consent as documented by signature

排除标准

  • Minor patients
  • Patients unable to participate due to the illness.
  • Patients that cannot sign informed consent
  • Patients extremely painful at the arrival (not possible for him to stay in a supine position).
  • Blood pressure difference between the two arms >10mmHg
  • Unstable patients requiring an urgent management

结局指标

主要结局

Confirmation of Blood pressure values measured simultanuously with the novel smartphone application

时间窗: during a 6 minutes period of time in the emergency department.

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

次要结局

  • Usability assessment(during a 6 minutes period of time in the emergency department.)

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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