NCT05659225

Telemedicine System and Intelligent Monitoring System Construction of Pediatric Asthma Based on the Electronic Stethoscope

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: Shanghai Children's Medical Center · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to retrofit the existing electronic stethoscope, improve the quality and efficiency of signal acquisition and the intelligent degree of information processing, decrease the manual action of electronic stethoscopes implemented by parents of asthma children, simplify the process of data transfer and the user's operational cost using signal processing, artificial intelligence technology, thus decreasing the feedback cycle between patients and clinicians. Eventually, we will construct an intelligent monitoring system based on the modified electronic stethoscope and explore the interactive remote management approaches on children's asthma at the same time, thus achieving revolutionized remote management of asthma.

Detailed description

(1) The design of hardware and software of the intelligent electronic stethoscope This project will optimize and develop the software and hardware equipment of electronic stethoscope according to the shortcomings of existing electronic stethoscopes. 1. Get high-quality breath sound data through integrated ECG sensor and algorithms for denoising and the separation of heart sound and lung sound 2. Develop algorithms and corresponding frameworks for visualization of breath sounds and mining of key information 3. Develop algorithms for automatic recognition of abnormal breath sounds 4. Transfer breath sound data efficiently and reliably based on the encoding-decoding architecture 5. Optimize the breath sound data transmission process 6. Construct the remote diagnosis and treatment methods and monitoring system for childhood asthma preliminary (2) The effect of telemedicine system and intelligent monitoring system based on intelligent stethoscope on children with asthma Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited. For each enrolled patient, basic information as well as baseline medical condition will be collected by the investigators. The subject will be randomly assigned to the control group and the electronic stethoscope group. The patient's caregiver who was assigned to the electronic stethoscope group will be instructed to install the electronic stethoscope developed by our team and its accessories, then they will be trained by investigators on how to use the electronic stethoscope. During the study, patients will receive 12 months standard treatment, prescribed by the investigators according to "Guideline for the diagnosis and optimal management of asthma in children". If patients develop upper respiratory tract symptoms without fever, the investigator will give corresponding guidance to the control group and the electronic stethoscope group. If fever develops, it is recommended that patients directly go to the emergency department. All patients' caregiver will be prompted to finish the test for respiratory and asthma control in kids (TRACK) every month. Patient's caregiver assigned to the electronic stethoscope group will also need to complete the collection, data upload and sharing of patient's breath sounds at least once a month to confirm that the electronic stethoscope is worked correctly. After enrollment, patients will be requested to visit Shanghai Children's Medical Center at month 3, 6, 9, 12. During each onsite visit, subjects will receive lung function (≥4 years) and FENO tests and fill out the questionnaire regarding the number of asthma-related outpatient emergency department visits, asthma-related hospitalizations, SABA and systemic glucocorticoid use, missed work and school misses, and asthma-related medical expenses in the past 3 months. At 6- and 12-month's visit, pediatric asthma caregiver's quality of Life questionnaire (PACQLQ) needs to be completed at the same time.

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	Electronic Stethoscope	Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment visit, V1). The subject will be assigned to the control group and the electronic stethoscope group and complete their future onsite visits (V2-V5) at Shanghai Children's Medical Center. The patient's caregiver who was assigned to the electronic stethoscope group will be instructed to install the electronic stethoscope developed by our team and its accessories, then they will be trained by investigators on how to use the electronic stethoscope.
OTHER	Standard treatment according to GINA(2019)	Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment visit, V1). The subject will be assigned to the control group and the electronic stethoscope group and complete their future onsite visits (V2-V5) at Shanghai Children's Medical Center. The patient's caregiver who was assigned to the control group will receieve standard treatment according to GINA(2019).

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-12-21
• Last updated: 2023-02-03

Locations

1 site across 1 country: China