Clinical Validation of a Custom Wearable Patch for Accurate and Comfortable Vital Sign Monitoring in Pediatric Patients
Year 2025,
Issue: Kabul Edilen Makaleler
Beren Semiz
Abstract
Background/Purpose: Measuring vital signs in pediatric patients requires special consideration and adaptation due to varying anatomy and wide age range. In addition, children's anxiety, uncooperativeness, and high activity levels further complicate measurements, necessitating devices and algorithms designed to minimize the inaccuracies and discomfort. In this work, the performance of a custom wearable patch mounted on the mid-sternum was validated in uncontrolled settings on a cohort including 84 pediatric patients.
Methods: Three-minute-long electrocardiogram (ECG), seismocardiogram (SCG) and photoplethysmogram (PPG) signals were acquired using the custom patch. First, pre-processing and signal smoothing algorithms were employed to suppress the out-of-band and motion noise. Two different tasks were then studied: (i) Heart rate (HR) and respiration rate were derived from the ECG, PPG and SCG signals individually. During HR derivation from the SCG, a novel Teager-energy-based HR estimation algorithm was proposed. (ii) Clinical relevance of the SCG signals was shown through mapping the SCG characteristics to body mass index (BMI) and blood pressure values.
Results: While the best HR estimation was achieved through the PPG-infrared signal with an absolute error of 2.22.1 bpm, the best respiration estimation was achieved with PPG-Red signal with an error of 2.62.2 breaths/min. On the other hand, regression models resulted in a minimum of 85% confidence interval, revealing that the SCG characteristics indeed have salient correlation with the BMI and blood pressure values.
Conclusion: Overall, such a system can potentially be leveraged in clinical practices to achieve more comfortable and accurate measurements.
Ethical Statement
The authors do not have any conflict of interest or competing interest to disclose. The study was conducted under a protocol approved by the Koc University Institutional Review Board (2023.408.IRB2.089) and all parents/guardians have provided their written consent.
Supporting Institution
This work was supported by the Scientific and Technological Research Council of Turkey (Grant Number: 121E133).
Project Number
Tübitak 121E133
Thanks
The corresponding author would like to thank Dr. Remziye Semerci, Hatice Seyrek and Ferzin Sinem Opak for their support during data collection, and Yusuf Ziya Hayirlioglu for his support during the hardware design.
References
- 1 Cdc. National Center for Health Statistics. Percentage of having a doctor visit for any reason in the past 12 months for children under age 18 years, United States, 2019—2023. National Health Interview Survey. . Accessed on: October 28, 2024. https://wwwn.cdc.gov/NHISDataQueryTool/SHS_child/index.html
- 2 Srinath S, Jacob P, Sharma E, et al. Clinical Practice Guidelines for Assessment of Children and Adolescents. Indian J Psychiatry. 2019;61:158-75. DOI:10.4103/psychiatry.IndianJPsychiatry_580_18
- 3 Stephan LM. Assessment of Growth and Vital Signs. Pediatric Physical Examination-E-Book: Pediatric Physical Examination-E-Book. 2023:10.
- 4 Engel JK. Mosby's Pocket Guide to Pediatric Assessment: Elsevier Health Sciences; 2006.
- 5 Espinoza J, Shah P, Nagendra G, et al. Pediatric Medical Device Development and Regulation: Current State, Barriers, and Opportunities. Pediatrics. 2022;149. DOI:10.1542/peds.2021-053390
- 6 Rostsinskaja A, Saard M, Sepp K, et al. Characteristics of Pediatric Hospital Fear and Efficiency of New Distraction Technique Holographic Display for Reducing Fear and Pain in Children. Techniques in Neurosurgery & Neurology. 2022;5.
- 7 Inan OT, Migeotte P-F, Park K-S, et al. Ballistocardiography and seismocardiography: A review of recent advances. IEEE journal of biomedical and health informatics. 2014;19:1414-27.
- 8 Wei Q, Wang Y, Zhou Z, et al. Classification of Heart Failure Based on Phase Trajectory Complexity of Seismocardiogram. IEEE Sensors Journal. 2023.
- 9 Erin E and Semiz B. Spectral Analysis of Cardiogenic Vibrations to Distinguish Between Valvular Heart Diseases. BIOSIGNALS; 2023. p. 212-9.
- 10 Ganti VG, Gazi AH, An S, et al. Wearable seismocardiography‐based assessment of stroke volume in congenital heart disease. Journal of the American Heart Association. 2022;11:e026067.
- 11 Sieciński S, Tkacz EJ and Kostka PS. Heart rate variability analysis on electrocardiograms, seismocardiograms and gyrocardiograms of healthy volunteers and patients with valvular heart diseases. Sensors. 2023;23:2152.
- 12 Liu L, Yu D, Lu H, et al. Camera-Based Seismocardiogram for Heart Rate Variability Monitoring. IEEE Journal of Biomedical and Health Informatics. 2024.
- 13 Sang B, Shokouhmand A, Wen H, et al. Identification of S2 paradoxical splitting in aortic stenosis subjects via seismocardiogram signals from a wearable accelerometer contact microphone. IEEE Sensors Journal. 2023;23:15424-34.
- 14 Nwibor C, Haxha S, Ali MM, et al. Remote health monitoring system for the estimation of blood pressure, heart rate, and blood oxygen saturation level. IEEE Sensors Journal. 2023;23:5401-11.
- 15 Karimpour P, May JM and Kyriacou PA. Photoplethysmography for the Assessment of Arterial Stiffness. Sensors. 2023;23:9882.
- 16 Chen Y, Yang X, Song R, et al. Predicting arterial stiffness from single-channel photoplethysmography signal: a feature interaction-based approach. IEEE Journal of Biomedical and Health Informatics. 2024.
- 17 Linh VTN, Han S, Koh E, et al. Advances in Wearable Electronics for Monitoring Human Organs: Bridging External and Internal Health Assessments. Biomaterials. 2024:122865.
- 18 Hayirlioglu YZ and Semiz B. PhysioPatch: A Multi-modal and Adaptable Wearable Patch for Cardiovascular and Cardiopulmonary Assessment. IEEE Sensors Journal. 2024.
- 19 Shandhi MMH, Semiz B, Hersek S, et al. Performance analysis of gyroscope and accelerometer sensors for seismocardiography-based wearable pre-ejection period estimation. IEEE journal of biomedical and health informatics. 2019;23:2365-74.
- 20 Carek AM, Conant J, Joshi A, et al. SeismoWatch: wearable cuffless blood pressure monitoring using pulse transit time. Proceedings of the ACM on interactive, mobile, wearable and ubiquitous technologies. 2017;1:1-16.
- 21 Morillo DS, Ojeda JLR, Foix LFC, et al. An accelerometer-based device for sleep apnea screening. IEEE transactions on information technology in biomedicine. 2009;14:491-9.
- 22 Kaiser JF. On a simple algorithm to calculate the'energy'of a signal. International conference on acoustics, speech, and signal processing: IEEE; 1990. p. 381-4.
- 23 Semiz B, Hersek S, Whittingslow DC, et al. Change point detection in knee acoustic emissions using the teager operator: A preliminary study in patients with juvenile idiopathic arthritis. 2019 IEEE EMBS International Conference on Biomedical & Health Informatics (BHI): IEEE; 2019. p. 1-4.
- 24 Semiz B, Carek AM, Johnson JC, et al. Non-invasive wearable patch utilizing seismocardiography for peri-operative use in surgical patients. IEEE journal of biomedical and health informatics. 2020;25:1572-82.
- 25 Centracchio J, Parlato S, Esposito D, et al. ECG-free heartbeat detection in seismocardiography signals via template matching. Sensors. 2023;23:4684.
- 26 Lin Y-D and Jhou Y-F. Estimation of heart rate and respiratory rate from the seismocardiogram under resting state. Biomedical Signal Processing and Control. 2020;57:101779.
- 27 Tokmak F and Semiz B. Investigating the Effect of Body Composition Differences on Seismocardiogram Characteristics. 2023 IEEE 36th International Symposium on Computer-Based Medical Systems (CBMS): IEEE; 2023. p. 323-8.
- 28 Hughes D, Babbs CF, Geddes L, et al. Measurements of Young's modulus of elasticity of the canine aorta with ultrasound. Ultrasonic imaging. 1979;1:356-67.
- 29 Payne R, Symeonides C, Webb D, et al. Pulse transit time measured from the ECG: an unreliable marker of beat-to-beat blood pressure. Journal of Applied Physiology. 2006;100:136-41.
- 30 Yang C and Tavassolian N. Pulse transit time measurement using seismocardiogram, photoplethysmogram, and acoustic recordings: Evaluation and comparison. IEEE journal of biomedical and health informatics. 2017;22:733-40.