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

• Published in: Journal of clinical monitoring and computing Vol. 36; no. 5; pp. 1525 - 1533
• Main Authors: Desebbe, Olivier, El Hilali, Mohammed, Kouz, Karim, Alexander, Brenton, Karam, Lydia, Chirnoaga, Dragos, Knebel, Jean-Francois, Degott, Jean, Schoettker, Patrick, Michard, Frederic, Saugel, Bernd, Vincent, Jean-Louis, Joosten, Alexandre
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer Netherlands 01.10.2022; Springer Nature B.V
• Subjects: Anesthesia; Anesthesiology; Blood pressure; Critical Care Medicine; Error analysis; Health Sciences; Intensive; Mean; Medicine; Medicine & Public Health; NCT; NCT04262323; Original Research; Performance evaluation; Risk; Smartphones; Statistical analysis; Statistics for Life Sciences; Postoperative; Arterial hypertension; Mobile phone; Hemodynamic; Mobile health; Hemodynamic monitoring
• ISSN: 1387-1307; 1573-2614
• DOI: 10.1007/s10877-021-00795-w

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 30 min 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 5 mmHg ± 8 mmHg. 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 + 1 mmHg ± 7 mmHg for mean arterial pressure (MAP), + 2 mmHg ± 11 mmHg for systolic arterial pressure (SAP), and + 1 mmHg ± 8 mmHg 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.