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Technical evaluation of a simulator for accurate reproduction of oscillometric blood pressure pulses, providing traceability for automated oscillometric sphygmomanometers

Lookup NU author(s): Emeritus Professor Alan MurrayORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

Creative Commons Attribution license. Oscillometric blood pressure measurement devices are not directly traceable to primary standards. Currently, device accuracy is measured by comparison between a sample device and reference measurements in a clinical trial. We researched in this study the potential for an alternative evaluation with a simulator. Our research simulator was studied for repeatability and accuracy in delivering simulated blood pressure pulses. Clinical cuff pressure measurements were obtained, along with simultaneous recordings of oscillometric pulse waveforms, spanning the clinical range of cuff pressures, pulse intervals and pulse shapes. Oscillometric pulse peak amplitudes ranged from 1.1 to 3.6 mmHg. Simulated repeatability results showed an average Standard Deviation (SD) for pulse peaks of 0.018 mmHg; 1.0% of peak amplitudes. Comparing simulated pulse shapes, the average repeat SD was 0.015 mmHg; 0.8% of the normalised pulse shapes. The simulated accuracy results had a mean error of - 0.014 ± 0.042 mmHg with a mean accuracy of 97.8%. For pulse shape the corresponding values were - 0.104 ± 0.071 mmHg with a mean accuracy of 95.4%. The correlation between the reference and simulated pulse shapes ranged from 0.991 to 0.996 (all p < 0.00003), with a mean 0.994. We conclude that oscillometric pulses can be reproduced with high repeatability and high accuracy with our research simulator. The extended uncertaintyU(psim) = 0.3 mmHg for the simulated pulses is dominated by the uncertainty (64%) of the clinical reference data. These results underpin the potential of the simulator to become a secondary standard for millions of oscillometric sphygmomanometers.


Publication metadata

Author(s): Mieke S, Murray A

Publication type: Article

Publication status: Published

Journal: Biomedical Physics & Engineering Express

Year: 2023

Volume: 9

Issue: 6

Online publication date: 12/09/2023

Acceptance date: 01/09/2023

Date deposited: 28/09/2023

ISSN (electronic): 2057-1976

Publisher: Institute of Physics Publishing Ltd

URL: https://doi.org/10.1088/2057-1976/acf5f4

DOI: 10.1088/2057-1976/acf5f4

Data Access Statement: All data that support the findings of this study are included within the article (and any supplementary files).

PubMed id: 37657422


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Funding

Funder referenceFunder name
EP/N025342/1EPSRC
European Metrology Programme for Innovation and Research (EMPIR)
European Union Horizon 2020

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