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Continuous vital sign monitoring using a wearable patch sensor in obese patients: a validation study in a clinical setting

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Abstract

Our aim was to determine the agreement of heart rate (HR) and respiratory rate (RR) measurements by the Philips Biosensor with a reference monitor (General Electric Carescape B650) in severely obese patients during and after bariatric surgery. Additionally, sensor reliability was assessed. Ninety-four severely obese patients were monitored with both the Biosensor and reference monitor during and after bariatric surgery. Agreement was defined as the mean absolute difference between both monitoring devices. Bland Altman plots and Clarke Error Grid analysis (CEG) were used to visualise differences. Sensor reliability was reflected by the amount, duration and causes of data loss. The mean absolute difference for HR was 1.26 beats per minute (bpm) (SD 0.84) during surgery and 1.84 bpm (SD 1.22) during recovery, and never exceeded the 8 bpm limit of agreement. The mean absolute difference for RR was 1.78 breaths per minute (brpm) (SD 1.90) during surgery and 4.24 brpm (SD 2.75) during recovery. The Biosensor’s RR measurements exceeded the 2 brpm limit of agreement in 58% of the compared measurements. Averaging 15 min of measurements for both devices improved agreement. CEG showed that 99% of averaged RR measurements resulted in adequate treatment. Data loss was limited to 4.5% of the total duration of measurements for RR. No clear causes for data loss were found. The Biosensor is suitable for remote monitoring of HR, but not RR in morbidly obese patients. Future research should focus on improving RR measurements, the interpretation of continuous data, and development of smart alarm systems.

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Availability of data and material

Data is available upon reasonable request

Code availability

We used the statistical software R (version 3.6.1, www.r-project.org). Figures were created using the R-package ‘ggplot2’.

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Acknowledgements

NK and GMP contributed equally to this work. The authors would like to thank the following persons from Rijnstate Hospital: José W.J.M. Geurts PhD and Pascal S.H. Smulders MSc, Department of Anesthesiology and Pain Management, for logistical support, Sjoerd J.A. Boogaard and Heleen M. Schoorl, Department of Information Technology, for technical support, Marieke J. Bosch, and Laura N. Deden, Vitalys Obesity Centre for the recruitment of patients. Finally, we would like to thank all the nurses from the Department of Bariatric Surgery, and patients for participating in this study.

Funding

Biosensors were provided free of charge by Philips. Other than that, support was provided solely from hospital and university sources.

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Author notes

  1. Niels Kant and Guido M. Peters have contributed equally to the work.

Authors and Affiliations

  1. Department of Anesthesiology and Pain Management, Rijnstate Hospital, Arnhem, The Netherlands

    Niels Kant, Mark V. Koning & Myra Rinia-Feenstra

  2. Scientific Bureau, Rijnstate Hospital, Rijnstate Research Center, Wagnerlaan 55, PO Box 9555, 6800 TA, Arnhem, The Netherlands

    Guido M. Peters & Carine J. M. Doggen

  3. Technical Medical Centre, Department of Health Technology and Services Research, University of Twente, Enschede, The Netherlands

    Guido M. Peters, Brenda J. Voorthuis, Catharina G. M. Groothuis-Oudshoorn & Carine J. M. Doggen

  4. Rijnstate Hospital, Vitalys Obesity Centre, Arnhem, The Netherlands

    Bart P. L. Witteman

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  1. Niels Kant
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Correspondence to Carine J. M. Doggen.

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Conflict of interest

Biosensors were provided free of charge by Philips. Other than that, support was provided solely from hospital and university sources. The authors declare no competing interests.

Ethical approval

Ethical approval for this study was asked for and waived by the Medical Research Ethics Committee Arnhem-Nijmegen, (registration 2019–5489). The study fell outside the remit of the law for Medical Research Involving Human Subjects Act and was approved by the local ethical committee.

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Written informed consent was obtained from all participants.

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Written informed consent for publication of their data to be used for scientific publication was obtained from all participants.

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Kant, N., Peters, G.M., Voorthuis, B.J. et al. Continuous vital sign monitoring using a wearable patch sensor in obese patients: a validation study in a clinical setting. J Clin Monit Comput 36, 1449–1459 (2022). https://doi.org/10.1007/s10877-021-00785-y

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  • DOI: https://doi.org/10.1007/s10877-021-00785-y

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