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Journal of Clinical Monitoring and Computing

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Open Access 19-01-2024 | Non-Invasive Ventilation | Original Research

A non-invasive continuous and real-time volumetric monitoring in spontaneous breathing subjects based on bioimpedance—ExSpiron®Xi: a validation study in healthy volunteers

Authors: Stefano Gatti, Emanuele Rezoagli, Fabiana Madotto, Giuseppe Foti, Giacomo Bellani

Published in: Journal of Clinical Monitoring and Computing | Issue 2/2024

Abstract

Tidal volume (TV) monitoring breath-by-breath is not available at bedside in non-intubated patients. However, TV monitoring may be useful to evaluate the work of breathing. A non-invasive device based on bioimpedance provides continuous and real-time volumetric tidal estimation during spontaneous breathing. We performed a prospective study in healthy volunteers aimed at evaluating the accuracy, the precision and the trending ability of measurements of ExSpiron®Xi as compared with the gold standard (i.e. spirometry). Further, we explored whether the differences between the 2 devices would be improved by the calibration of ExSpiron®Xi with a pre-determined tidal volume. Analysis accounted for the repeated nature of measurements within each subject. We enrolled 13 healthy volunteers, including 5 men and 8 women. Tidal volume, TV/ideal body weight (IBW) and respiratory rate (RR) measured with spirometer (TV_Spirometer) and with ExSpiron®Xi (TV_ExSpiron) showed a robust correlation, while minute ventilation (MV) showed a weak correlation, in both non/calibrated and calibrated steps. The analysis of the agreement showed that non-calibrated TV_ExSpiron underestimated TV_spirometer, while in the calibrated steps, TV_ExSpiron overestimated TV_spirometer. The calibration procedure did not reduce the average absolute difference (error) between TV_Spirometer and TV_ExSpiron. This happened similarly for TV/IBW and MV, while RR showed high accuracy and precision. The trending ability was excellent for TV, TV/IBW and RR. The concordance rate (CR) was >95% in both calibrated and non-calibrated measurements. The trending ability of minute ventilation was limited. Absolute error for both calibrated and not calibrated values of TV, TV/IBW and MV accounting for repeated measurements was variably associated with BMI, height and smoking status. Conclusions: Non-invasive TV, TV/IBW and RR estimation by ExSpiron®Xi was strongly correlated with tidal ventilation according to the gold standard spirometer technique. This data was not confirmed for MV. The calibration of the device did not improve its performance. Although the accuracy of ExSpiron®Xi was mild and the precision was limited for TV, TV/IBW and MV, the trending ability of the device was strong specifically for TV, TV/IBW and RR. This makes ExSpiron®Xi a non-invasive monitoring system that may detect real-time tidal volume ventilation changes and then suggest the need to better optimize the patient ventilatory support.

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Title: A non-invasive continuous and real-time volumetric monitoring in spontaneous breathing subjects based on bioimpedance—ExSpiron®Xi: a validation study in healthy volunteers
Authors: Stefano Gatti
Emanuele Rezoagli
Fabiana Madotto
Giuseppe Foti
Giacomo Bellani
Publication date: 19-01-2024
Publisher: Springer Netherlands
Keywords: Non-Invasive Ventilation
Spirometry
Published in: Journal of Clinical Monitoring and Computing / Issue 2/2024
Print ISSN: 1387-1307
Electronic ISSN: 1573-2614
DOI: https://doi.org/10.1007/s10877-023-01107-0

Keynote webinar | Spotlight on medication adherence

Springer Medicine

A non-invasive continuous and real-time volumetric monitoring in spontaneous breathing subjects based on bioimpedance—ExSpiron®Xi: a validation study in healthy volunteers

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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