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. 2021 Dec 1;26(6):441-448.
doi: 10.1097/MBP.0000000000000556.

Smartphone based blood pressure measurement: accuracy of the OptiBP mobile application according to the AAMI/ESH/ISO universal validation protocol

Jean Degott  1 , Arlene Ghajarzadeh-Wurzner  2 , Gregory Hofmann  1 , Martin Proença  3 , Guillaume Bonnier  3 , Alia Lemkaddem  3 , Mathieu Lemay  3 , Urvan Christen  4 , Jean-François Knebel  4 , Virginie Durgnat  2 , Michel Burnier  2 , Gregoire Wuerzner  2 , Patrick Schoettker  1
Affiliations

Smartphone based blood pressure measurement: accuracy of the OptiBP mobile application according to the AAMI/ESH/ISO universal validation protocol

Jean Degott et al. Blood Press Monit. .

Abstract

Objective: 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).

Methods: 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.

Results: 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%.

Conclusion: 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.

Trial registration: ClinicalTrials.gov NCT03875248.

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Conflict of interest statement

M.P., G.B., A.L. and M.L. are with CSEM, the owners of the optical blood pressure monitoring technology and assignee of the related application (WO2016138965A1), of which M.P. and M.L. are inventors. U.C. and J-F.K. are working for Biospectal SA. P.S. is an advisor to Biospectal. Innosuisse - Swiss Innovation Agency, Project no. 32688.1 IP-ICT had no role in study design, data collection nor analysis, in the writing of the report nor in the decision to submit the article for publication. For the remaining authors, there are no conflicts of interest.

Figures

Fig. 1
Fig. 1
Fingertip on the smartphone’s camera [12]. OptiBP app utilizes image data generated from volumetric blood flow changes via light passing through the fingertip, reflecting off of blood flowing through the vessels, and then passing to the phone camera’s image sensor.
Fig. 2
Fig. 2
Setting for opposite arm simultaneous method according to ISO 81060-2:2018
Fig. 3
Fig. 3
OptiBP analysis.
Fig. 4
Fig. 4
Consort flow diagram.
Fig. 5
Fig. 5
Standardized Bland–Altman scatterplots of the OptiBP-Reference BP differences against their average.
See this image and copyright information in PMC

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