Clinical Trial: The Accuracy of an Artificially-intelligent Stethoscope
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Comparison of the Accuracy of an Artificially-Intelligent Stethoscope Versus Pediatric Cardiologists in the Assessment of Pediatric Patients Referred to a Cardiologist for the Assessment of a
Brief Summary: This study will characterize the accuracy of a commercially available artificially-intelligent stethoscope in determining which childhood murmurs suggest underlying congenital structural heart disease and therefore warrant diagnostic echocardiograms.
Detailed Summary:
Heart murmurs can be ausculted in most pediatric patients, but underlying Congenital Structural Heart (CSH) Disease is rare. Nevertheless, CSH Disease is often first suggested by the presence of a murmur. Primary care providers refer pediatric patients to Cardiologists for murmur evaluations with low accuracy, and this pattern results in:
- needless emotional strain on many patients with functionally normal hearts and their families,
- increased morbidity and mortality rates for rare patients with delayed cardiac diagnoses, and
- exorbitant costs to society.
Referral accuracy for murmur evaluations probably is low because the differences between innocent and pathological murmurs can be subtle. Computer-assisted analysis of heart sounds may increase the accuracy of primary care referrals to pediatric cardiologists, but the accuracy of the only FDA-approved artificially-intelligent cardiac auscultation system, Zargis Medical Corporation's Cardioscan®, has never been determined prospectively in an unselected population of live pediatric patients. As a primary endpoint, the study herein proposed would prospectively compare the sensitivity and specificity of the Cardioscan® with that of CHMCA's Pediatric Cardiologists in the identification of cardiac pathology among 300 new and unselected pediatric patients referred to CHMCA's cardiologists for murmur evaluations, using two-dimensional transthoracic echocardiography as the common gold-standard. Double-blinding will be in place. The study also will attempt secondarily to gauge the clinical significance of pathology missed by the Cardioscan®, to define sub-populations of patients among which the Cardioscan's® judgment should be considered less accurate, and t
Sponsor: Akron Children's Hospital
Current Primary Outcome: Sensitivity of the Artificially-Intelligent Stethoscope as compared with that of Pediatric Cardiologists in determining which patients needed echocardiograms because they have congenital structural heart disease [ Time Frame: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours. ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Specificity of the Artificially-Intelligent Stethoscope as compared with that of Pediatric Cardiologists in determining which patients needed echocardiograms because they have congenital structural heart disease. [ Time Frame: Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours. ]
Original Secondary Outcome: Same as current
Information By: Akron Children's Hospital
Dates:
Date Received: November 23, 2007
Date Started: December 2007
Date Completion:
Last Updated: October 31, 2011
Last Verified: October 2011
