Evaluation of a novel optical smartphone blood pressure application: a method comparison study against invasive arterial blood pressure monitoring in intensive care unit patients

Olivier Desebbe, Chbabou Anas, Brenton Alexander, Karim Kouz, Jean-Francois Knebel, Patrick Schoettker, Jacques Creteur, Jean-Louis Vincent, Alexandre Joosten, Olivier Desebbe, Chbabou Anas, Brenton Alexander, Karim Kouz, Jean-Francois Knebel, Patrick Schoettker, Jacques Creteur, Jean-Louis Vincent, Alexandre Joosten

Abstract

Background: Arterial hypertension is a worldwide public health problem. While it is currently diagnosed and monitored non-invasively using the oscillometric method, having the ability to measure blood pressure (BP) using a smartphone application could provide more widespread access to hypertension screening and monitoring. In this observational study in intensive care unit patients, we compared blood pressure values obtained using a new optical smartphone application (OptiBP™; test method) with arterial BP values obtained using a radial artery catheter (reference method) in order to help validate the technology.

Methods: We simultaneously measured three BP values every hour for five consecutive hours on two consecutive days using both the smartphone and arterial methods. Bland-Altman and error grid analyses were used for agreement analysis between both approaches. The performance of the smartphone application was investigated using the Association for the Advancement of Medical Instrumentation (AAMI) and the International Organization for Standardization (ISO) definitions, which require the bias ± SD between two technologies to be below 5 ± 8 mmHg.

Results: Among the 30 recruited patients, 22 patients had adequate OptiBP™ values and were thus analyzed. In the other 8 patients, no BP could be measured due to inadequate signals. The Bland-Altman analysis revealed a mean of the differences ± SD between both methods of 0.9 ± 7 mmHg for mean arterial pressure (MAP), 0.2 ± 14 mmHg for systolic arterial pressure (SAP), and 1.1 ± 6 mmHg for diastolic arterial pressure (DAP). Error grid analysis demonstrated that the proportions of measurement pairs in risk zones A to E were 88.8% (no risk), 10% (low risk), 1% (moderate risk), 0% (significant risk), and 0% (dangerous risk) for MAP and 88.4%, 8.6%, 3%, 0%, 0%, respectively, for SAP.

Conclusions: This method comparison study revealed good agreement between BP values obtained using the OptiBP™ and those done invasively. The OptiBP™ fulfills the AAMI/ISO universal standards for MAP and DAP (but not SAP). Error grid showed that the most measurements (≥ 97%) were in risk zones A and B.

Trial registration: ClinicalTrials.gov registration: NCT04728477.

Keywords: Arterial hypertension, mobile phone; Hemodynamic; Hemodynamic monitoring; International standards; Mobile health; Optical signal.

Conflict of interest statement

OD is consultant for Medtronic (Trévoux, FRANCE) and and Livanova (Châtillon, France). JFK is working for Biospectal SA, Lausanne, Switzerland.

PS is an advisor of Biospectal SA, Lausanne, Switzerland AJ is a consultant for Edwards Lifesciences (Irvine, California, USA) The other authors have no conflicts of interest to declare.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Description of the smartphone application: Fingertip on the smartphone’s camera OptiBP™ app uses image data generated from volumetric blood flow changes via light passing through the fingertip, reflecting off blood flowing through the vessels, and then passing to the phone camera's image sensor
Fig. 2
Fig. 2
Bland–Altman plots showing the agreement between the smartphone application for mean arterial pressure (MAP) measurements and the reference method (upper arm oscillometry)
Fig. 3
Fig. 3
Bland–Altman plots showing the agreement between the smartphone application for systolic blood pressure (SAP) measurements and the reference method (upper arm oscillometry)
Fig. 4
Fig. 4
Bland–Altman plots showing the agreement between the smartphone application for diastolic blood pressure (DAP) measurements and the reference method (upper arm oscillometry)
Fig. 5
Fig. 5
Error grid analysis comparing systolic (left panel) and mean (right panel) arterial blood pressure measurements from the smartphone application with those from the radial artery catheter (reference method). The background colors correspond to the continuous risk level for each pair of measurements. The continuous risk level ranges from 0 to 100% as shown at the bottom of the figure

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