基于网络的智能手机算法用于在一般成年人群中远程通过光电容积脉搏波描记法计算血压：验证研究

Web-Based Smartphone Algorithm for Calculating Blood Pressure From Photoplethysmography Remotely in a General Adult Population: Validation Study.

作者信息

Holyoke Paul, Yogaratnam Karthika, Kalles Elizabeth

机构信息

SE Research Centre, SE Health, Markham, ON, Canada.

出版信息

J Med Internet Res. 2021 Apr 23;23(4):e19187. doi: 10.2196/19187.

DOI:10.2196/19187

PMID:33890856

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8105754/

Abstract

BACKGROUND

Outside of a clinical setting, oscillometric devices make remote monitoring of blood pressure and virtual care more convenient and feasible. HeartBeat Technologies Ltd developed a novel approach to measuring blood pressure remotely after an initial blood pressure reading by a nurse using the conventional measurement method. Using a finger pulse oximeter, a photoplethysmogram wave is transmitted by Bluetooth to a smartphone or tablet. A smartphone app (MediBeat) transmits the photoplethysmogram to a server for analysis by a proprietary algorithm-the person's current blood pressure is sent back to the smartphone and to the individual's health care provider.

OBJECTIVE

This study sought to determine whether the HeartBeat algorithm calculates blood pressure as accurately as required by the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) for validation of blood pressure measuring devices.

METHODS

ESH-IP2 requirements, modified to conform to a more recent international consensus statement, were followed. The ESH-IP2 establishes strict guidelines for the conduct and reporting of any validation of any device to measure blood pressure, including using the standard manual blood pressure instrument as a comparator and specific required accuracy levels for low, medium, and high ranges of blood pressure readings. The consensus statement requires a greater number of study participants for each of the blood pressure ranges. The validation of the accuracy of the algorithm was conducted with a Contec CMS50EW pulse oximeter and a Samsung Galaxy XCover 4 smartphone.

RESULTS

The differences between the HeartBeat-calculated and the manually measured blood pressures of 62 study participants did not meet the ESH-IP2 standards for accuracy for either systolic or diastolic blood pressure measurements. There was no discernible pattern in the inaccuracies of the HeartBeat-calculated measurements.

CONCLUSIONS

The October 4, 2019 version of the HeartBeat algorithm, implemented in combination with the MediBeat app, a pulse oximeter, and an Android smartphone, was not sufficiently accurate for use in a general adult population.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04082819; http://clinicaltrials.gov/ct2/show/NCT04082819.

摘要

背景

在临床环境之外，示波测量设备使血压的远程监测和虚拟护理更加便捷可行。心跳技术有限公司开发了一种新颖的方法，在护士使用传统测量方法进行初始血压读数后，可远程测量血压。使用手指脉搏血氧仪，通过蓝牙将光电容积脉搏波传输到智能手机或平板电脑。一款智能手机应用程序（MediBeat）将光电容积脉搏波传输到服务器，由专有算法进行分析，然后将个人当前的血压发送回智能手机和个人的医疗保健提供者。

目的

本研究旨在确定心跳算法计算血压的准确性是否符合欧洲高血压学会2010年国际协议修订版（ESH - IP2）对血压测量设备验证的要求。

方法

遵循经修改以符合最新国际共识声明的ESH - IP2要求。ESH - IP2为任何血压测量设备的验证行为和报告制定了严格指南，包括使用标准手动血压仪器作为对照以及对低、中、高范围血压读数的特定所需准确度水平。共识声明要求每个血压范围有更多的研究参与者。使用康泰CMS50EW脉搏血氧仪和三星Galaxy XCover 4智能手机对算法的准确性进行验证。