跳至主要内容
临床试验/NCT06791096
NCT06791096招募中不适用

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

Kun Sun2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2025年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
420
试验地点
2
主要终点
Sensitivity of auscultation in CHD detection: Primary Care Physicians' Independent Auscultation & AI-Assisted Auscultation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Independent auscultation

Active Comparator

干预措施: Independent auscultation (Diagnostic Test)

AI-assisted auscultation

Experimental

干预措施: AI-assisted auscultation (Diagnostic Test)

结局指标

主要结局

Sensitivity of auscultation in CHD detection: Primary Care Physicians' Independent Auscultation & AI-Assisted Auscultation

时间窗: From enrollment to the end of treatment at 3 months

次要结局

  • 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: 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)
  • 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)

研究者

发起方
Kun Sun
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kun Sun

Professor of Department of Pediatric Cardiology

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (2)

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