Efficacy Comparison Between Primary Care Physicians' Independent Auscultation and AI-assisted Auscultation for Congenital Heart Disease Screening in Patient-enriched Populations: a Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Congenital Heart Disease (CHD); Screening Tool; Artifical Intelligence; Randomised Controlled Trial; Auscultation for Clinical Evaluation

• Registration Number: NCT06791096
• Lead Sponsor: Kun Sun

Brief Summary

In recent years, the application of artificial intelligence (AI) in the healthcare domain has witnessed a significant surge, with deep learning emerging as a potent force in the medical field. Deep learning algorithms possess the remarkable ability to automatically extract intricate features and patterns, thereby facilitating highly accurate heart sound recognition. Drawing on this technological advancement, Professor Sun Kun and his research team from Xinhua Hospital, in collaboration with numerous centers spanning across China, have been diligently investigating the development and application of AI-assisted heart sound recognition for congenital heart disease (CHD) screening.

Utilizing electronic stethoscopes to meticulously collect heart sounds, and harnessing AI algorithms to analyze extensive datasets comprising heart sounds from both children diagnosed with CHD and those who are healthy, the system has been trained to adeptly differentiate between normal and pathological murmurs. The current iteration of the system boasts an impressive accuracy and sensitivity rate of 90%.

This study is designed as a randomized controlled trial (RCT) to be conducted at Shanghai Xinhua Hospital and Qinghai Provincial Women and Children's Hospital. The primary objective is to demonstrate the superiority of AI-assisted primary care physicians in identifying CHD over primary care physicians working independently. This will be achieved by conducting a comparative analysis of the performance of AI-assisted physicians versus their unassisted counterparts, thereby substantiating the model's practical applicability. Through an ongoing process of refinement and widespread application, this pioneering research endeavors to empower a diverse range of medical professionals, including general practitioners, child health physicians, and non-cardiovascular specialists, with the transformative capabilities of AI-assisted electronic auscultation. The ultimate goal is to elevate the standard of pediatric care across the nation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-18
• Study First Submitted QC: 2025-01-18
• Study Start: 2025-02-10
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-05-28
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

• Age between 0 to 18 years, with no gender restrictions.
• Children who consent to undergo echocardiography to determine the presence or absence of congenital heart disease.
• Voluntary participation in this study and signing of an informed consent form.

Exclusion Criteria

• Age greater than 18 years.
• Children who are unable to undergo echocardiography or who do not cooperate with auscultation.
• Participants who cannot provide informed consent or are unwilling to comply with study requirements to provide medical data for further analysis and research.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sensitivity of auscultation in CHD detection: Primary Care Physicians' Independent Auscultation & AI-Assisted Auscultation	From enrollment to the end of treatment at 3 months

Secondary Outcome Measures

Name	Time	Method
Specificity, accuracy, and false negatives of auscultation in CHD detection: Primary Care Physicians' Independent Auscultation & AI-Assisted Auscultation	From enrollment to the end of treatment at 3 months
Specificity, accuracy, and false negatives of auscultation in CHD detection: Specialist Physicians' Independent Auscultation & AI-Assisted Auscultation By Primary Care Physician	From enrollment to the end of treatment at 3 months
Sensitivity, specificity, accuracy, and false negatives of auscultation in CHD detection: Primary Care Physicians' Independent Auscultation & AI Model	From enrollment to the end of treatment at 3 months
Specificity, accuracy, and false negatives of auscultation in CHD detection: Specialist Physicians' Independent Auscultation & Primary Care Physicians' Independent Auscultation	From enrollment to the end of treatment at 3 months
Sensitivity, specificity, accuracy, and false negatives of auscultation in CHD detection: Specialist Physicians' Independent Auscultation & AI Model	From enrollment to the end of treatment at 3 months
The rate of diagnostic revisions by physicians, the proportions of correct and incorrect changes	From enrollment to the end of treatment at 3 months

Trial Locations

Locations (2)

Qinghai Provincial Women and Children's Hospital; 🇨🇳 Qinghai, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China