Reliability Analysis and Clinical Validation of Smart Portable ECG Devices for Home Patient Cardiac Care

Reliability Analysis and Clinical Validation of Smart Portable ECG Devices for Home Patient Cardiac Care | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Reliability Analysis and Clinical Validation of Smart Portable ECG Devices for Home Patient Cardiac Care Kunvar Kant Patel, Basant Kumar This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5424534/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract This research paper presents a detailed reliability analysis and validation of a smartphone-based Electrocardiogram (ECG) acquisition device (Spandan) for prior-cardiac disorder detection for home patients. Numerous IoT-based wearable medical devices for continuous cardiovascular signal monitoring are available; however, conducting validation and reliability analyses of these medical devices is crucial to ensure their effectiveness. The study includes 28 normal and abnormal participants for the investigation of the Spandan ECG device. It aims to validate and assess the reliability of the Spandan ECG device with respect to the RMS Vesta 301i ECG device (standard 12-lead ECG device). So, this study compares the time interval of the ECG parameters of the Spandan ECG device with the RMS Vesta 301i ECG device. The statistical analysis reveals that the Spandan ECG device achieves an overall accuracy of 95.3% with respect to the RMS Vesta 301i ECG device. The investigation of the reliability of the Spandan devices is assessed using Bland-Altman limits of agreement, Intra-class correlation coefficient (ICC), Paired t-tests, Repeatability test, and Pearson coefficient. The ICC is evaluated with a high value of 0.9957 (99.57%), demonstrating the excellent reliability of Spandan ECG devices. The obtained p-value is 0.0001, which signifies a substantial degree of agreement between Spandan and the RMS Vesta 301i ECG device. Spandan ECG device Intra-class correlation coefficient (ICC) Instrument reliability Device validation Paired t-tests Bland-Altman limits of agreement Full Text Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 11 Nov, 2025 Reviewers invited by journal 18 Apr, 2025 Editor assigned by journal 01 Apr, 2025 First submitted to journal 29 Mar, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5424534","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":444728096,"identity":"e845e6c6-71f2-4ceb-9b5e-b7175e136358","order_by":0,"name":"Kunvar Kant Patel","email":"data:image/png;base64,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","orcid":"https://orcid.org/0000-0003-4812-3694","institution":"Motilal Nehru National Institute of Technology","correspondingAuthor":true,"prefix":"","firstName":"Kunvar","middleName":"Kant","lastName":"Patel","suffix":""},{"id":444728097,"identity":"8f6e7ad8-84f8-4c74-83de-0bffd3904b9a","order_by":1,"name":"Basant Kumar","email":"","orcid":"","institution":"MNNIT Allahabad: Motilal Nehru National Institute of Technology","correspondingAuthor":false,"prefix":"","firstName":"Basant","middleName":"","lastName":"Kumar","suffix":""}],"badges":[],"createdAt":"2024-11-10 06:36:10","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5424534/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5424534/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":81020014,"identity":"f39d6f71-5563-496e-aacc-2b099644e36e","added_by":"auto","created_at":"2025-04-21 09:33:08","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":857286,"visible":true,"origin":"","legend":"","description":"","filename":"ManuscriptRevisionSOCOD2404826.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5424534/v1_covered_085fb634-d2b2-445d-94df-243e64ebe152.pdf"}],"financialInterests":"","formattedTitle":"Reliability Analysis and Clinical Validation of Smart Portable ECG Devices for Home Patient Cardiac Care","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"soft-computing","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"soco","sideBox":"Learn more about [Soft Computing](https://www.springer.com/journal/500)","snPcode":"500","submissionUrl":"https://submission.nature.com/new-submission/500/3","title":"Soft Computing","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Spandan ECG device, Intra-class correlation coefficient (ICC), Instrument reliability, Device validation, Paired t-tests, Bland-Altman limits of agreement","lastPublishedDoi":"10.21203/rs.3.rs-5424534/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5424534/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eThis research paper presents a detailed reliability analysis and validation of a smartphone-based Electrocardiogram (ECG) acquisition device (Spandan) for prior-cardiac disorder detection for home patients. 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