Evaluation of a new smartphone optical blood pressure application (OptiBP™) in the post-anesthesia care unit: a method comparison study against the non-invasive automatic oscillometric brachial cuff as the reference method.

Abstract

We compared blood pressure (BP) values obtained with a new optical smartphone application (OptiBP™) with BP values obtained using a non-invasive automatic oscillometric brachial cuff (reference method) during the first 2 h of surveillance in a post-anesthesia care unit in patients after non-cardiac surgery. Three simultaneous BP measurements of both methods were recorded every 30min over a 2-h period. The agreement between measurements was investigated using Bland-Altman and error grid analyses. We also evaluated the performance of the OptiBP™ using ISO81060-2:2018 standards which requires the mean of the differences ± standard deviation (SD) between both methods to be less than 5mmHg ± 8mmHg. Of 120 patients enrolled, 101 patients were included in the statistical analysis. The Bland-Altman analysis demonstrated a mean of the differences ± SD between the test and reference methods of + 1mmHg ± 7mmHg for mean arterial pressure (MAP), + 2mmHg ± 11mmHg for systolic arterial pressure (SAP), and + 1mmHg ± 8mmHg for diastolic arterial pressure (DAP). Error grid analysis showed that the proportions of measurement pairs in risk zones A to E were 90.3% (no risk), 9.7% (low risk), 0% (moderate risk), 0% (significant risk), 0% (dangerous risk) for MAP and 89.9%, 9.1%, 1%, 0%, 0% for SAP. We observed a good agreement between BP values obtained by the OptiBP™ system and BP values obtained with the reference method. The OptiBP™ system fulfilled the AAMI validation requirements for MAP and DAP and error grid analysis indicated that the vast majority of measurement pairs (≥ 99%) were in risk zones A and B.Trial Registration ClinicalTrials.gov Identifier: NCT04262323.