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Feasibility study of the use of a wearable vital sign patch in an intensive care unit setting

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Abstract

Multiple studies and review papers have concluded that early warning systems have a positive effect on clinical outcomes, patient safety and clinical performances. Despite the substantial evidence affirming the efficacy of EWS applications, persistent barriers hinder their seamless integration into clinical practice. Notably, EWS, such as the National Early Warning Score, simplify multifaceted clinical conditions into singular numerical indices, thereby risking the oversight of critical clinical indicators and nuanced fluctuations in patients’ health status. Furthermore, the optimal deployment of EWS within clinical contexts remains elusive. Manual assessment of EWS parameters exacts a significant temporal toll on healthcare personnel. Addressing these impediments necessitates innovative approaches. In this regard, wearable medical technologies emerge as promising solutions capable of continual monitoring of hospitalized patients’ vital signs. To overcome the barriers of the use of early warning scores, wearable medical technology has the potential to continuously monitor vital signs of hospitalised patients. However, a fundamental inquiry arises regarding the comparability of their reliability to the current used golden standards. This inquiry underscores the imperative for rigorous evaluation and validation of wearable medical technologies to ascertain their efficacy in augmenting extant clinical practices. This prospective, single-center study aimed to evaluate the accuracy of heart rate and respiratory rate measurements obtained from the Vivalink Cardiac patch in comparison to the ECG-based monitoring system utilized at AZ Maria Middelares Hospital in Ghent. Specifically, the study focused on assessing the concordance between the data obtained from the Vivalink Cardiac patch and the established ECG-based monitoring system among a cohort of ten post-surgical intensive care unit (ICU) patients. Of these patients, five were undergoing mechanical ventilation post-surgery, while the remaining five were not. The study proceeded by initially comparing the data recorded by the Vivalink Cardiac patch with that of the ECG-based monitoring system. Subsequently, the data obtained from both the Vivalink Cardiac patch and the ECG-based monitoring system were juxtaposed with the information derived from the ventilation machine, thereby providing a comprehensive analysis of the patch’s performance in monitoring vital signs within the ICU setting. For heart rate, the Vivalink Cardiac patch was on average within a 5% error range of the ECG-based monitoring system during 85.11±10.81% of the measured time. For respiratory rate this was during 40.55±17.28% of the measured time. Spearman’s correlation coefficient showed a very high correlation of \(\rho = 0.9\)8 for heart rate and a moderate correlation of \(\rho = 0.66\) for respiratory rate. In comparison with the ventilated respiratory rate (ventilation machine) the Vivalink and ECG-based monitoring system both had a moderate correlation of \(\rho = 0.68.\) A very high correlation was found between the heart rate measured by the Vivalink Cardiac patch and that of the ECG-based monitoring system of the hospital. Concerning respiratory rate the correlation between the data from the Vivalink Cardiac patch, the ECG-based monitoring system and the ventilation machine was found to be moderate.

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Acknowledgements

The authors express their sincere appreciation to the general hospital Maria Middelares for providing the necessary facilities and allowing patient recruitment on campus. Additionally, heartfelt thanks are extended to the SQuaD team of the Department of Anesthesiology and Intensive Care for their invaluable collaboration in enrolling patients for this study.

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The authors have not disclosed any funding.

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Authors and Affiliations

  1. Departement of Electronics and Information Systems - IBiTech, Ghent University, Korneel Heymanslaan, Gent, 9000, East-Flanders, Belgium

    Guylian Stevens & Pascal Verdonck

  2. H3CareSolutions, Henegouwenstraat 41, Gent, 9000, East-Flanders, Belgium

    Guylian Stevens

  3. Partnership of Anesthesia, AZ Maria Middelares Hospital, Buitenring Sint-Denijs 30, Gent, 9000, East-Flanders, Belgium

    Michiel Larmuseau, Annelies Van Damme, Henk Vanoverschelde & Jan Heerman

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  1. Guylian Stevens
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  2. Michiel Larmuseau
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  3. Annelies Van Damme
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  4. Henk Vanoverschelde
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  5. Jan Heerman
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  6. Pascal Verdonck
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Contributions

GS authored the main manuscript text, meticulously prepared the figures and tables, and conducted data processing, while also contributing to the drafting of the submission for editorial consideration. ML was instrumental in extracting hospital data and provided valuable insights into data processing techniques. JH provided clinical expertise and played a pivotal role in defining the study protocol. AVD was responsible for patient inclusions and contributing to the drafting of the submission for editorial consideration. PV provided invaluable guidance on data processing methodologies. All authors diligently reviewed and contributed to the refinement of the manuscript.

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Correspondence to Guylian Stevens.

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Stevens, G., Larmuseau, M., Damme, A.V. et al. Feasibility study of the use of a wearable vital sign patch in an intensive care unit setting. J Clin Monit Comput 39, 245–256 (2025). https://doi.org/10.1007/s10877-024-01207-5

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