Accepted for/Published in: JMIR Biomedical Engineering
Date Submitted: Feb 7, 2020
Date Accepted: Mar 21, 2020
Clinical comparison of a new smart wearable wireless heart rate and SpO2 monitoring system with standard monitoring in the ICU: a pilot trial
ABSTRACT
Background:
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.
Objective:
To test the value of a this new wireless sensor design (SmartCardia) in clinic and to show it usefulness in patients 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 define of optimal correlation between the gold standard and the wireless system if values differ < 10 % for HR and < 4 % for SpO2. 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 782.3 hours. The mean difference and standard deviation between the HR detected by the SmartCardia patch and the ICU monitor was 5.87 ± 16.01 bpm (bias = -5.66±16.09). For SpO2, the average difference and standard deviation was 3.54 ± 3.86 % (bias=2.9±4.36) for interpretable values. 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 %.
Conclusions:
SmartCardia device demonstrated clinically acceptable accuracies for HR and SpO2 monitoring in ICU patients.
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