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
Sponsor: Kun Sun
Trial Details
| Condition | Congenital Heart Disease (CHD), Screening Tool, Artificial Intelligence (AI), Cluster Randomized Trial, Auscultation for Clinical Evaluation |
| Intervention | Primary care physicians; AI + Primary care physicians |
| Phase | NA |
| Status | Completed |
| Participants | 19,697 |
| Est. Completion | 18 Nov 2025 |
| Last Updated | 7 Apr 2026 |
Primary Outcome
Sensitivity of auscultation in identifying CHD between independent auscultation by primary care physicians and AI-assisted auscultation by primary care physicians
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria (Schools): * The school is of the type: kindergarten, primary school, junior high school, or senior high school. * The school has medical screening facilities and conditions that can support AI-assisted screening. * The area where the school is located has at least one primary healthcare institution willing to participate in this trial. * The school's management and teaching staff are willing to participate in the study and can cooperate to complete the related screening and data collection work. Exclusion Criteria (Schools): * More than half of the students in the school refuse to participate in the trial. * Schools that are unable to complete the study due to severe limitations in geographical location and transportation conditions. * Schools lacking medical screening facilities and conditions necessary for the implementation of screening. * Areas where there are no primary healthcare institutions willing to participate in this trial. * Schools whose management and teaching staff refuse to participate in the study or are unable to cooperate in completing the related screening and data collection work. Inclusion Criteria (Individuals): * Children aged between 0 and 18 years, regardless of gender. * Children who agree to undergo echocardiography to determine the presence of congenital heart disease. * Individuals who voluntarily participate in this study and sign the informed consent form. Exclusion Criteria (Individuals): * Individuals over the age of 18. * Children who are unable to complete echocardiography or do not cooperate with auscultation. * Participants who are unable to provide informed consent or are unwilling to comply with the study requirements to provide medical data for further analysis and research. * Participants who have received interventional or surgical treatment for CHD.
Trial Sites
Countries
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