RecruitingNot ApplicableNCT06791096

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


Sponsor

Kun Sun

Enrollment

420 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

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Interventions

DIAGNOSTIC_TESTAI-assisted auscultation

The study begins with non-blinded staff collecting medical histories and specialist physicians conducting face-to-face auscultations and assessments. Then, primary care doctors will conduct face-to-face auscultations and first assessments, and use AI-assisted stethoscopes to collect heart sounds following a set protocol. The AI model will analyze the data in real-time and provides an immediate diagnostic result, which is relayed back to the primary care physicians. Based on this, they will make a secondary assessment. All participants will undergo echocardiography.

DIAGNOSTIC_TESTIndependent auscultation

It includes medical history collection by non-blinded independent personnel, face-to-face auscultation and evaluations conducted by specialist physicians and primary care doctors separately. All participants will undergo echocardiography.


Locations(2)

Qinghai Provincial Women and Children's Hospital

Qinghai, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

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NCT06791096


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