Efficacy Comparison Between Independent Auscultation by Primary Care Physicians and AI-Assisted Auscultation in Large-scale Screening for Congenital Heart Disease: A Cluster Randomized Controlled Trial in China

Not Applicable

Recruiting

• Conditions: Congenital Heart Disease (CHD); Artificial Intelligence (AI); Cluster Randomized Trial; Screening Tool; Auscultation for Clinical Evaluation

• Registration Number: NCT06791109
• Lead Sponsor: Kun Sun

Brief Summary

This study plans to conduct clinical validation of the model in real clinical settings, comparing it with primary care physicians and specialist physicians to ensure the model's practicality. Through continuous optimization and practice, the study aims to use AI-assisted heart sound auscultation to empower the auscultation capabilities of primary care obstetricians, pediatricians, and non-cardiovascular specialists nationwide. This will not only reduce the missed diagnosis rate and improve the detection rate of existing CHD screenings, but also expand the coverage of current CHD screening networks, incorporating newborns, infants, preschool children, children, and adolescents aged 0-18 years into the screening scope. The study aims to establish a new benchmark in child health management by providing feasible and cost-effective child health management solutions for other developing countries, contributing to global efforts for the health of children.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-18
• Study First Submitted QC: 2025-01-18
• Study First Posted: 2025-01-24
• Status Verified: 2025-09
• Study Start: 2025-09-22
• Last Update Submitted: 2025-09-22
• Last Update Posted: 2025-09-26
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28833

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sensitivity of auscultation in identifying CHD between independent auscultation by primary care physicians and AI-assisted auscultation by primary care physicians	From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Name	Time	Method
Specificity, accuracy, and false negatives of Auscultation in CHD Detection: Primary Care Physicians' Independent Auscultation & AI-assisted Primary Healthcare Physicians' Auscultation	From enrollment to the end of treatment at 6 months
The rate of diagnostic revisions by physicians, the proportions of correct and incorrect changes	From enrollment to the end of treatment at 6 months
Sensitivity, specificity, accuracy, and false negatives of auscultation in CHD detection: Primary Care Physicians/Experienced Cardiologists' Independent Auscultation & AI Model	From enrollment to the end of treatment at 6 months
Sensitivity, specificity, accuracy, and false negatives of Auscultation in CHD Detection: Specialist Physicians' Independent Auscultation & AI-assisted Primary Healthcare Physicians' Auscultation	From enrollment to the end of treatment at 6 months

Trial Locations

Locations (1)

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