Department of Anesthesiology.
Service of Nephrology and Hypertension, Lausanne University Hospital and University of Lausanne, Lausanne.
Blood Press Monit. 2021 Dec 1;26(6):441-448. doi: 10.1097/MBP.0000000000000556.
The aim of this study was to assess the accuracy of the OptiBP mobile application based on an optical signal recorded by placing the patient's fingertip on a smartphone's camera to estimate blood pressure (BP). Measurements were carried out in a general population according to existing standards of the Association for the Advancement of Medical Instrumentation (AAMI), the European Society of Hypertension (ESH) and the International Organization for Standardization (ISO).
Participants were recruited during a scheduled appointment at the hypertension clinic of Lausanne University Hospital in Switzerland. Age, gender and BP distribution were collected to fulfill AAMI/ESH/ISO universal standards. Both auscultatory BP references and OptiBP were measured and compared using the opposite arm simultaneous method as described in the 81060-2:2018 ISO norm.
A total of 353 paired recordings from 91 subjects were analyzed. For validation criterion 1, the mean ± SD between OptiBP and reference BP recordings was respectively 0.5 ± 7.7 mmHg and 0.4 ± 4.6 mmHg for SBP and DBP. For validation criterion 2, the SD of the averaged BP differences between OptiBP and reference BP per subject was 6.3 mmHg and 3.5 mmHg for SBP and DBP. OptiBP acceptance rate was 85%.
The smartphone embedded OptiBP cuffless mobile application fulfills the validation requirements of AAMI/ESH/ISO universal standards in a general population for the measurement of SBP and DBP.
本研究旨在评估基于将患者指尖放置在智能手机相机上记录的光学信号来估计血压（BP）的 OptiBP 移动应用程序的准确性。根据美国医疗器械促进协会（AAMI）、欧洲高血压学会（ESH）和国际标准化组织（ISO）的现有标准，在普通人群中进行了测量。
参与者是在瑞士洛桑大学医院高血压诊所预约时招募的。收集年龄、性别和血压分布数据，以满足 AAMI/ESH/ISO 通用标准。采用 ISO 81060-2:2018 标准中描述的同时对侧手臂测量法，同时测量并比较听诊血压参考值和 OptiBP。
共分析了 91 名受试者的 353 对记录。对于验证标准 1，OptiBP 和参考 BP 记录之间的平均 ± SD 分别为 SBP 和 DBP 的 0.5 ± 7.7 mmHg 和 0.4 ± 4.6 mmHg。对于验证标准 2，OptiBP 和参考 BP 之间的平均 BP 差异的每个受试者的 SD 分别为 SBP 和 DBP 的 6.3 mmHg 和 3.5 mmHg。OptiBP 的接受率为 85%。
在普通人群中，智能手机嵌入式 OptiBP 无袖带移动应用程序满足 AAMI/ESH/ISO 通用标准测量 SBP 和 DBP 的验证要求。
