Although many wearable single-lead electrocardiogram (ECG) monitoring devices have been developed, information regarding their ECG quality is limited. This study aimed to evaluate the quality of single-lead ECG in healthy subjects under various conditions (body positions and motions) and in patients with arrhythmias, to estimate requirements for automatic analysis, and to identify a way to improve ECG quality by changing the type and placement of electrodes. A single-lead ECG transmitter was placed on the sternum with a pair of electrodes, and ECG was simultaneously recorded with a conventional Holter ECG in 12 healthy subjects under various conditions and 35 patients with arrhythmias. Subjects with arrhythmias were divided into sinus rhythm (SR) and atrial fibrillation (AF) groups. ECG quality was assessed by calculating the sensitivity and positive predictive value (PPV) of the visual detection of QRS complexes (vQRS), automatic detection of QRS complexes (aQRS), and visual detection of P waves (vP). Accuracy was defined as a 100% sensitivity and PPV. We also measured the amplitude of the baseline, P wave, and QRS complex, and calculated the signal-to-noise ratio (SNR). We then focused on aQRS and estimated thresholds to obtain an accurate aQRS in more than 95% of the data. Finally, we sought to improve ECG quality by changing electrode placement using offset-type electrodes in 10 healthy subjects. The single-lead ECG provided 100% accuracy for vQRS, 87% for aQRS, and 74% for vP in healthy subjects under various conditions. Failure for accurate detection occurred in several motions in which the baseline amplitude was increased or in subjects with low QRS or P amplitude, resulting in low SNR. The single-lead ECG provided 97% accuracy for vQRS, 80% for aQRS in patients with arrhythmias, and 95% accuracy for vP in the SR group. The AF group showed higher baseline amplitude than the SR group (0.08mV vs. 0.02mV, P < 0.01) but no significant difference in accuracy for aQRS (79% vs. 81%, P = 1.00). The thresholds to obtain an accurate aQRS were a QRS amplitude > 0.42mV and a baseline amplitude < 0.20mV. The QRS amplitude was significantly influenced by electrode placement and body position (P < 0.01 for both, two-way analysis of variance), and the maximum reduction by changing body position was estimated as 30% compared to the sitting posture. The QRS amplitude significantly increased when the inter-electrode distance was extended vertically (1.51mV for vertical extension vs. 0.93mV for control, P < 0.01). The single-lead ECG provided at least 97% accuracy for vQRS, 80% for aQRS, and 74% for vP. To obtain stable aQRS in any body positions, a QRS amplitude > 0.60mV and a baseline amplitude < 0.20mV were required in the sitting posture considering the reduction induced by changing body position. Vertical extension of the inter-electrode distance increased the QRS amplitude.
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