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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

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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 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.

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Acknowledgements

All the clinicians and nurses from the emergency department.

Funding

This work was supported by the Department of Anesthesiology, Erasme Hospital, Brussels.

Author information

Authors and Affiliations

  1. Department of Anesthesiology & Perioperative Medicine, Sauvegarde Clinic, Ramsay Santé, Lyon, France

    Olivier Desebbe

  2. Department of Anesthesiology, Erasme University Hospital, Université Libre de Bruxelles, 808 Route de Lennik, 1070, Brussels, Belgium

    Mohammed El Hilali, Dragos Chirnoaga & Alexandre Joosten

  3. Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany

    Karim Kouz & Bernd Saugel

  4. Department of Anesthesiology, University of California San Diego, La Jolla, CA, USA

    Brenton Alexander

  5. Department of Anesthesiology and Intensive Care, Hôpitaux Universitaires Paris-Sud, Université Paris-Sud, Université Paris-Saclay, Paul Brousse Hospital, Assistance Publique Hôpitaux de Paris (APHP), Villejuif, France

    Lydia Karam & Alexandre Joosten

  6. Biospectal SA, 1003, Lausanne, Switzerland

    Jean-Francois Knebel

  7. Department of Anesthesiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland

    Jean Degott & Patrick Schoettker

  8. MiCo, Denens, Switzerland

    Frederic Michard

  9. Outcome Research Consortium, Cleveland, OH, USA

    Bernd Saugel

  10. Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, 808 Route de Lennik, 1070, Brussels, Belgium

    Jean-Louis Vincent

  11. Department of Anesthesiology, Erasme Hospital, 808, Route de Lennik, 1070, Brussels, Belgium

    Alexandre Joosten

Authors
  1. Olivier Desebbe
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  2. Mohammed El Hilali
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  3. Karim Kouz
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  4. Brenton Alexander
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  5. Lydia Karam
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  6. Dragos Chirnoaga
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  7. Jean-Francois Knebel
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  8. Jean Degott
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  9. Patrick Schoettker
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  10. Frederic Michard
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  11. Bernd Saugel
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  12. Jean-Louis Vincent
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  13. Alexandre Joosten
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Contributions

All authors read and approved the final manuscript. OD: designed the study, analyzed the data and edited the final manuscript. MEH: collected and analyzed the data and edited the final manuscript. KK: collected the data and edited the final manuscript. BA: analyzed the data and edited the final manuscript. LK: analyzed the data and edited the final manuscript. DC: analyzed the data and edited the final manuscript. JFK: analyzed the data and edited the final manuscript. JD: analyzed the data and edited the final manuscript. PS: analyzed the data and edited the final manuscript. FM: analyzed the data and edited the final manuscript. BS: analyzed the data and edited the final manuscript. JLV: analyzed the data and edited the final manuscript. AJ: designed the study, analyzed the data and drafted the manuscript.

Corresponding author

Correspondence to Alexandre Joosten.

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Conflict of interest

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.

Ethical approval

The present study was approved by the ethics committee of Erasme Hospital on October 20th, 2020 under the reference A2020/199 and registered in Clinical Trial.gov on February 10th, 2020 under the reference NCT04262323 (Principal Investigator: Alexandre Joosten).

Consent to participate

Written informed consent was obtained from all individual participants included in the study.

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Not applicable.

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Appendix 1: Boxplots of mean of the differences at each time point

Appendix 1: Boxplots of mean of the differences at each time point

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Desebbe, O., El Hilali, M., Kouz, K. et al. 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. J Clin Monit Comput 36, 1525–1533 (2022). https://doi.org/10.1007/s10877-021-00795-w

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