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

Paurakh Lal Rajbhandary, Gabriel Nallathambi, Nandakumar Selvaraj, Thang Tran, Olivier Colliou, Paurakh Lal Rajbhandary, Gabriel Nallathambi, Nandakumar Selvaraj, Thang Tran, Olivier Colliou

Abstract

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.

Keywords: Bipolar lead; ECG intervals; Electrocardiogram; Lead II; P-wave; Wearable patch.

© 2022. The Author(s) under exclusive licence to Biomedical Engineering Society.

Figures

Figure 1
Figure 1
Top and bottom views of VitalPatch sensor.
Figure 2
Figure 2
Layout of electrode placement of VitalPatch sensor and 12-lead ECG device in Mason-Likar position. RA, LA, RL, and LL are the right arm, left arm, right leg, and left leg electrodes, respectively, from which the limb leads and augmented leads are obtained.
Figure 3
Figure 3
An example of simultaneous ECG signal obtained from VitalPatch sensor and 12-lead ECG device in Mason-Likar position.
Figure 4
Figure 4
Illustration of features of ECG that were manually annotated in the VitalPatch and the 12-lead device.
Figure 5
Figure 5
Hypothesis testing for VitalPatch ECG compared to leads of 12-lead ECG. (a) Hρ matrix (see Eq. (4)). (b) Hr matrix (see Eq. (5)). The white background fields represent the rejection of the null hypothesis and ‘-’ represents the fields excluded from hypothesis testing.
Figure 6
Figure 6
Representative ECG signal with an ectopic beat from leads I, II, V3 and V4 of 12-lead ECG that are closest to the VitalPatch in terms of correlation coefficient and normalized Root Mean Square Error (RMSE).

References

    1. Areia C, Young L, Vollam S, Ede J, Santos M, Tarassenko L, Watkinson P. Wearability Testing of Ambulatory Vital Sign Monitoring Devices: Prospective Observational Cohort Study. JMIR mHealth and uHealth. 2020;8(12):e20214. doi: 10.2196/20214.
    1. Armstrong JS, Collopy F. Error measures for generalizing about forecasting methods: Empirical comparisons. International journal of forecasting. 1992;8(1):69–80. doi: 10.1016/0169-2070(92)90008-W.
    1. Bansal A, Joshi R. Portable out-of-hospital electrocardiography: A review of current technologies. Journal of arrhythmia. 2018;34(2):129–138. doi: 10.1002/joa3.12035.
    1. Boddy R, Smith G. Statistical Methods in Practice: For scientists and technologists. Chicester: Wiley; 2009. pp. 95–96.
    1. Braunstein E, Reynbakh O, Krumerman A, Di Biase L, Ferrick K. Inpatient cardiac monitoring using a patch-based mobile cardiac telemetry system during the COVID-19 pandemic. Journal of cardiovascular electrophysiology. 2020;31(11):2803–2811. doi: 10.1111/jce.14727.
    1. Braunwald E, Douglas PZ, Peter L. Heart Disease: A Textbook of Cardiovascular Medicine. 6. Philadelphia: Saunders; 2001.
    1. Dar, T., Y. Bharath, R. Gopinathannair, and D. Lakkireddy. Current advances in wearable health technology: a review. Electrophysiol. Lab Digest 18(3), 2018.
    1. Fung E, Järvelin MR, Doshi RN, Shinbane JS, Carlson SK, Grazette LP, Chang PM, Sangha RS, Huikuri HV, Peters NS. Electrocardiographic patch devices and contemporary wireless cardiac monitoring. Frontiers in physiology. 2015;6:149. doi: 10.3389/fphys.2015.00149.
    1. Henian X, Garcia G. A., Zhao X. Automatic detection of ECG electrode misplacement: a tale of two algorithms. Physiological measurement. 2012;33(9):1549. doi: 10.1088/0967-3334/33/9/1549.
    1. Kancharla K, Estes NAM. Mobile cardiac monitoring during the COVID-19 pandemic: Necessity is the mother of invention. Journal of cardiovascular electrophysiology. 2020;31(11):2812–2813. doi: 10.1111/jce.14726.
    1. Kania M, Rix H, Fereniec M, Zavala-Fernandez H, Janusek D, Mroczka T, Stix G, Maniewski R. The effect of precordial lead displacement on ECG morphology. Medical & biological engineering & computing. 2014;52(2):109–119. doi: 10.1007/s11517-013-1115-9.
    1. Klum M, Minn T, Tigges T, Pielmus AG, Orglmeister R. Minimally spaced electrode positions for multi-functional chest sensors: ECG and respiratory signal estimation. Current Directions in Biomedical Engineering. 2016;2(1):695–699. doi: 10.1515/cdbme-2016-0151.
    1. Lateef F, Annathurai A, Loh TT. The V-Quick patch versus the standard 12-lead ECG system: time is the essence. International journal of emergency medicine. 2008;1(1):43–48. doi: 10.1007/s12245-008-0008-4.
    1. Levine DM, Ouchi K, Blanchfield B, Saenz A, Burke K, Paz M, Diamond K, Pu CT, Schnipper JL. Hospital-level care at home for acutely ill adults a randomized controlled trial. Annals of internal medicine. 2020;172(2):77–85. doi: 10.7326/M19-0600.
    1. Link MS, Berkow LC, Kudenchuk PJ, Halperin HR, Hess EP, Moitra VK, Neumar RW, O’Neil BJ, Paxton JH, Silvers SM, White RD, Yannopoulos D, Donnino MW. Part 7: adult advanced cardiovascular life support: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015;132(suppl 2):S444–S464.
    1. Malik M, Bigger JT, Camm AJ, Kleiger RE, Malliani A, Moss AJ, Schwartz PJ. Heart rate variability: Standards of measurement, physiological interpretation, and clinical use. European heart journal. 1996;17(3):354–381. doi: 10.1093/oxfordjournals.eurheartj.a014868.
    1. Mckay C. Probability and Statistics, p. 257, 2019. ISBN 9781839473302.
    1. Mittal S, Steinberg JS. Ambulatory external electrocardiographic monitoring: focus on atrial fibrillation. J. Am. Colloid Cardiol. 2011;58(17):1741–1749. doi: 10.1016/j.jacc.2011.07.026.
    1. Nallathambi, G., N. Selvaraj, P. L. Rajbhandary. An innovative hybrid approach for detection of pacemaker pulses at low sampling frequency. 42nd Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), pp. 5012–5015, 2020.
    1. Nasiff CardioCard - PC based Holter ECG System . Accessed Oct 4, 2021.
    1. Olson JA, Fouts AM, Padanilam BJ, Prystowksy EN. Utility of mobile cardiac outpatient telemetry for the diagnosis of palpitations, presyncope, syncope, and the assessment of therapy efficacy. Journal of cardiovascular electrophysiology. 2007;18(5):473–477. doi: 10.1111/j.1540-8167.2007.00779.x.
    1. Powers DMW. Evaluation: From Precision, Recall and F-Measure to ROC, Informedness, Markedness & Correlation. Journal of Machine Learning Technologies. 2011;2(1):37–63.
    1. Puurtinen M, Hyttinen J, Malmivuo J. Optimizing bipolar electrode location for wireless ECG measurement-analysis of ECG signal strength and deviation between individuals. International Journal of Bioelectromagnetism. 2005;7(1):236–239.
    1. Puurtinen M, Viik J, Hyttinen J. Best electrode locations for a small bipolar ECG device: signal strength analysis of clinical data. Annals of biomedical engineering. 2009;37(2):331–336. doi: 10.1007/s10439-008-9604-y.
    1. Rajbhandary, P. L., G. Nallathambi. Feasibility of continuous monitoring of core body temperature using chest-worn patch sensor. 42nd Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), pp. 4652–4655, 2020.
    1. Ramirez AH, Schildcrout JS, Blakemore DL, Masys DR, Pulley JM, Basford MA, Roden DM, Denny JC. Modulators of normal electrocardiographic intervals identified in a large electronic medical record. Heart Rhythm. 2011;8(2):272–277. doi: 10.1016/j.hrthm.2010.10.034.
    1. Selvaraj, N. Long-term remote monitoring of vital signs using a wireless patch sensor. IEEE Healthcare Innovation Conference (HIC), 2014.
    1. Selvaraj, N., G. Nallathambi, and P. Kettle. A novel synthetic simulation platform for validation of breathing rate measurement. 40th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), pp. 1177–1180, 2018.
    1. Selvaraj, N., G. Nallathambi, R. Moghadam, and A. Aga. Fully disposable wireless patch sensor for continuous remote patient monitoring. 40th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), pp. 1632–1635, 2018.
    1. Tonino RPB, Larimer K, Eissen O, Schipperus MR. Remote patient monitoring in adults receiving transfusion or infusion for hematological disorders using the VitalPatch and accelerateIQ Monitoring System: Quantitative Feasibility Study. JMIR Hum. Factors. 2019;6(4):e15103. doi: 10.2196/15103.
    1. Van’t Hof AW, Liem A, de Boer MJ, Zijlstra F. Clinical value of 12-lead electrocardiogram after successful reperfusion therapy for acute myocardial infarction. The Lancet. 1997;350(9078):615–619. doi: 10.1016/S0140-6736(96)07120-6.
    1. VitalConnect Platform: Instruction for Use - VitalPatch Biosensor . Accessed Oct 4, 2021.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する