Key result
A toilet seat-based electrocardiogram achieved clinical grade accuracy for heart rate, heart rate variability, QRS duration, and QTc interval compared to a standard Lead II ECG.
Why the study?
Does a toilet seat-based buttocks ECG with custom algorithms accurately measure ECG parameters compared to a clinical grade 12-lead ECG in normative and HF subjects?
Observational (n=54)
Yes
Does a toilet seat-based buttocks ECG with custom algorithms accurately measure ECG parameters compared to a clinical grade 12-lead ECG in normative and HF subjects?
A toilet seat-based ECG remote monitoring system with custom algorithms can extract clinical-grade ECG measures, offering potential for inconspicuous in-home monitoring.
May enable passive home ECG monitoring in HF; hypothesis-generating pending outcome trials.
Background: Wearable and connected in-home medical devices are typically utilized in uncontrolled environments and often measure physiologic signals at suboptimal locations. Motion artifacts and reduced signal-to-noise ratio, compared with clinical grade equipment, results in a highly variable signal quality that can change significantly from moment to moment. The use of signal quality classification algorithms and robust feature delineation algorithms designed to achieve high accuracy on poor quality physiologic signals can prove beneficial in addressing concerns associated with measurement accuracy, confidence, and clinical validity. Objective: The objective of this study was to demonstrate the successful extraction of clinical grade measures using a custom signal quality classification algorithm for the rejection of poor-quality regions and a robust QRS delineation algorithm from a nonstandard electrocardiogram (ECG) integrated into a toilet seat; a device plagued by many of the same challenges as wearable technologies and other Internet of Things–based medical devices. Methods: The present algorithms were validated using a study of 25 normative subjects and 29 heart failure (HF) subjects. Measurements captured from a toilet seat-based buttocks electrocardiogram were compared with a simultaneously captured 12-lead clinical grade ECG. The ECG lead with the highest morphological correlation to buttocks electrocardiogram was used to determine the accuracy of the heart rate (HR), heart rate variability (HRV), which used the standard deviation of the normal-to-normal (SDNN) intervals between sinus beats, QRS duration, and the corrected QT interval (QTc). These algorithms were benchmarked using the MIT-BIH Arrhythmia Database (MITDB) and European ST-T Database (EDB), which are standardized databases commonly used to test QRS detection algorithms. Results: Clinical grade accuracy was achieved for all buttocks electrocardiogram measures compared with standard Lead II. For the normative cohort, the mean was −0.0 (SD 0.3) bpm (N=141 recordings) for HR accuracy and −1.0 (SD 3.4) ms for HRV (N=135). The QRS duration and the QTc interval had an accuracy of −0.5 (SD 6.6) ms (N=85) and 14.5 (SD 11.1) ms (N=85), respectively. In the HF cohort, the accuracy for HR, HRV, QRS duration, and QTc interval was 0.0 (SD 0.3) bpm (N=109), −6.6 (SD 13.2) ms (N=99), 2.9 (SD 11.5) ms (N=59), and 11.2 (SD 19.1) ms (N=58), respectively. When tested on MITDB and EDB, the algorithms presented herein had an overall sensitivity and positive predictive value of over 99.82% (N=900,059 total beats), which is comparable to best in-class algorithms tuned specifically for use with these databases. Conclusions: The present algorithmic approach to data analysis of noisy physiologic data was successfully demonstrated using a toilet seat-based ECG remote monitoring system. This approach to the analysis of physiologic data captured from wearable and connected devices has future potential to enable new types of monitoring devices, providing new insights through daily, inconspicuous in-home monitoring.
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Conn et al. (2018) conducted an observational in Heart Failure (n=54). Toilet seat-based buttocks electrocardiogram (bECG) vs. Standard 12-lead clinical grade ECG (Lead II) was evaluated on Accuracy of heart rate, heart rate variability, QRS duration, and QTc interval compared to standard Lead II. A toilet seat-based electrocardiogram achieved clinical grade accuracy for heart rate, heart rate variability, QRS duration, and QTc interval compared to a standard Lead II ECG.
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