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临床试验/NCT04082819
NCT04082819已完成不适用

Determining the Accuracy of the HeartBeat Algorithm for Calculating Blood Pressure

SE Health2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2019年10月4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
94
试验地点
2
主要终点
Difference Between Systolic Manual Sphygmomanometer and Finger Pulse Oximeter Readings

研究概览

简要总结

The goal of the study was to compare the current gold standard blood pressure instrument (a mercury-filled sphygmomanometer with cuff and stethoscope) with the new experimental algorithm developed by HeartBeat Technologies Ltd. To that end, participants were recruited from Markham, Ontario and participated in a series of alternating blood pressure measurements over a period of 45 minutes. Comparisons were made between manual measurements and device measurements to determine the quality of the device readings. Measurements were taken by trained nurses and staff were consistent across the study duration.

详细描述

The gold standard instrument for blood pressure measurement is a mercury-filled sphygmomanometer with cuff and stethoscope (Canadian Agency for Drugs and Technologies in Health; Canadian Electronic Library, 2012). However, such a device is not the most convenient for client self-monitoring or virtual (remote) care. Thus, there is a desire for an accurate, reliable alternative for the traditional mercury-containing sphygmomanometer.

HeartBeat Technologies Ltd. ("Heartbeat") has developed a novel approach to measuring blood pressure after an initial blood pressure reading using the conventional measurement method, supplemented by specific characteristics of a person (age, gender, height, weight, and heart rate), has established a "baseline measurement" for the person. The "novel approach" uses a finger pulse oximeter, the Contec CMS50EW device (Figure 1) (manufactured by Contec Medical Systems Co., Ltd., Shanghai, People's Republic of China). The finger pulse oximeter detects the changes in blood volume directly below the person's skin and indirectly measures oxygen saturation in the blood. The measurement is in the form of a photoplethysmogram (PPG) which is captured by the Contec oximeter and then, by Bluetooth technology, transmitted to a smartphone or tablet. A HeartBeat application, called MediBeat, on the smartphone or tablet then transmits the PPG to a server where a proprietary algorithm analyzes the baseline measurement for the person and the PPG to calculate the person's current blood pressure.

Heartbeat's intent is that the current blood pressure reading would then be made available to both the client and the health provider through separate web-based interfaces. Providers would be able to log onto the HeartBeat web-based application from anywhere to review and monitor the blood pressure of multiple clients, while clients can log onto the application to track their own measurements.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult over 25 years of age

排除标准

  • those who have heart arrhythmias,
  • atrial fibrillations or atrial flutters,
  • an inaudible Korotkoff sound,
  • wounds of the upper arms/wrists, missing fingers, and/or
  • an arm circumference of more than 55 cm will be excluded

结局指标

主要结局

Difference Between Systolic Manual Sphygmomanometer and Finger Pulse Oximeter Readings

时间窗: 45 - 60 minutes

Each device reading was compared to the manual blood pressure reading taken before (R1) and after it (R2). The degree of alignment for systolic blood pressure was calculated by taking the difference between the two scores (manual and device). The reading with the best alignment was used.

Difference Between Diastolic Manual and Device Blood Pressure Readings

时间窗: 45-60 minutes

Each device reading was compared to the manual reading before (R1) and after (R2) it, to calculate the degree of alignment. The difference of the device and R1, and the device and R2 were taken. The smaller number was used for results reporting.

次要结局

未报告次要终点

研究者

发起方
SE Health
申办方类型
Other
责任方
Sponsor

研究点 (2)

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