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The purpose of this research is to develop a body voice artificial intelligence (AI) recognition device, also referred to as an AI-assisted body sound identification device, by utilizing a deep learning-based novel AI algorithm in conjunction with a big body voice model. It could identify normal and abnormal heart, breath, and bowel sounds, and to provide early screening and auxiliary diagnosis of congenital heart disease (CHD), respiratory infections, diarrhea and other common multi-occurring diseases.
The study employed a multicenter cross-sectional design. The real-world data collected for this study included normal and definitively diagnosed heart sounds in children with congenital heart disease, normal and definitively diagnosed respiratory tract infections in children with breath sounds, specific cough sounds, and normal and definitively diagnosed children's bowel sounds with diarrhea. The specialist team will carry out data governance, annotation, and feature sound extraction on the gathered normal and aberrant sounds, in order to generate a superior multimodal training dataset. Large model artificial intelligence algorithms (deep learning, machine learning, etc.) are used to model and train the algorithm model of the body voice AI recognition device, so that it can distinguish between normal and abnormal sound signals by AI. The results of body sound AI identification will be compared with diagnostic reports from echocardiograms, chest X-rays, and belly X-rays in terms of AUC (Area Under Curve) score, sensitivity, specificity, and accuracy to evaluate the impact of AI recognition devices on illness screening and supplementary diagnosis. External validation will be conducted using homogeneous data from other sites. This project aims to develop a new generation of intelligent sound auscultation instruments that could be used for early screening and auxiliary diagnosis of congenital heart disease , respiratory infections, diarrhea and other common multi-occurring diseases by utilizing large model artificial intelligence technologies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0 ~ 18 years old children | Age range: 0 to 18 years old, with no gender restriction. Children who have been diagnosed with congenital heart disease (CHD) or confirmed to be free of CHD through echocardiographic examinations. Children who have been diagnosed with bronchopneumonia or confirmed to be free of bronchopneumonia through chest imaging examinations. Children who have been diagnosed with abdominal diseases or confirmed to be free of abdominal diseases through abdominal imaging examinations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart Auscultation and Echocardiography | Diagnostic Test | Heart auscultation will be done by pediatrician and echocardiography by echocardiologist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Sensitivity in CHD, lung disease and abdominal screening by different artificial intelligence algorithm and auscultation | 1 month |
| Specificity | Specificity in CHD, lung disease and abdominal screening by different artificial intelligence algorithm and auscultation | 1 month |
| AUC | AUC in CHD, lung disease and abdominal screening by different artificial intelligence algorithm and auscultation | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Sun, MD | Contact | 0086-021-25077480 | sunxin@xinhuamed.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xin Sun, MD | Xinhua Hospital, Shanghai J iao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Children's Hospital (Wuhan Maternal and Child Healthcare Hospital), Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430016 | China |
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| Chest Auscultation and Chest imaging examinations | Diagnostic Test | Chest auscultation will be done by pediatrician and chest imaging examinations by radiologist |
|
| Abdominal Auscultation and Abdominal imaging examinations | Diagnostic Test | Abdominal auscultation will be done by pediatrician and chest imaging examinations by radiologist |
|
| Human Children's Hospital | Changsha | Hunan | 410007 | China |
|
| Xinhua Hospital,Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200092 | China |
|
| Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200127 | China |
|
| Kunming children's Hospital | Kunming | Yunnan | 650028 | China |
|
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D001996 | Bronchopneumonia |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D006326 | Heart Auscultation |
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D001314 | Auscultation |
| D010808 | Physical Examination |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D014463 | Ultrasonography |
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