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Study validating Heart Rate and SpO2 of SmartCardia patch in ICU

Clinical comparison of a new smart wearable wireless heart rate and SpO2 monitoring system with standard monitoring in the ICU: a pilot trial

S. Murali, F. Rincon, T. Cassina, S. Cook, J. J. Goy

Abstract

Continuous cardiac monitoring with wireless sensors is attractive for early detection of arrhythmia and conduction disturbances, and to prevent adverse events leading to patient deterioration. We present a new sensor design (SmartCardia), a wearable wireless biosensor patch, for continuous cardiac and SpO2 monitoring. Methods: We performed an observational study, HR and SpO2 of patients admitted in the ICU. A comparison of the device under test (SmartCardia, Lausanne,Switzerland) and the unit grade monitoring system (Dräger-Healthcare, Lübeck, Germany) of the ICU was done. We estimated a 95% limits of values agreement as reasonable. Data loss and discrepancy between the 2 systems were critically analyzed. Results: Fifty-eight patients (42 men and 16 women) with a mean age of 71±11 years hospitalized in the ICU were included. A total of 13.49 ± 5.53 hours per patient were recorded. This represents a total recorded period of 782.29 hours. The mean difference and standard deviation between the HR detected by the SmartCardia patch and the ICU monitor was 6± 13 bpm or 8 ± 19 % of heart rate. For SpO2, the average difference and standard deviation was 3.9 ± 2.9 %. SmartCardia’s patch measures SpO2 only under low to no activity condition and does not report a value otherwise. Data loss and non- interpretable values of SpO2 represent 26 ± 24 % of the total number of values. Conclusion: SmartCardia device demonstrated clinically acceptable accuracies for HR and SpO2 monitoring in ICU patients.

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