ECG Signal Quality Assessments of a Small Bipolar Single-Lead Wearable Patch Sensor

PURPOSE: There is an increasing clinical interest in the adoption of small single-lead wearable ECG sensors for continuous cardiac monitoring. The purpose of this work is to assess ECG signal quality of such devices compared to gold standard 12-lead ECG. METHODS: The ECG signal from a 1-lead patch was systematically compared to the 12-lead ECG device in thirty subjects to establish its diagnostic accuracy in terms of clinically relevant signal morphology, wave representation, fiducial markers and interval and wave duration. One minute ECG segments with good signal quality was selected for analysis and the features of ECG were manually annotated for comparative assessment. RESULTS: The patch showed closest similarity based on correlation and normalized root-mean-square error to the standard ECG leads I, II, [Formula: see text] and [Formula: see text] . P-wave and QRS complexes in the patch showed sensitivity (Se) and positive predictive value (PPV) of at least 99.8% compared to lead II. T-wave representation showed Se and PPV of at least 99.9% compared to lead [Formula: see text] and [Formula: see text] . Mean errors for onset and offset of the ECG waves, wave durations, and ECG intervals were within 2 samples based on 125Hz patch ECG sampling frequency. CONCLUSION: This study demonstrates the diagnostic capability with similar morphological representation and reasonable timing accuracy of ECG signal from a patch sensor compared to 12-lead ECG. The advantages and limitations of small bipolar single-lead wearable patch sensor compared to 12-lead ECG are discussed in the context of relevant differences in ECG signal for clinical applications.