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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Qinghai Provincial Women and Children's Hospital
NOT_YET_RECRUITING
Qinghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Kun Sun, Phd
drsunkun@xinhuamed.com.cn
021-13601846338
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 420
Treatments
Active_comparator: Independent auscultation
Experimental: AI-assisted auscultation
Related Therapeutic Areas
Sponsors
Collaborators: Bill and Melinda Gates Foundation
Leads: Kun Sun

This content was sourced from clinicaltrials.gov