Clinical Trials Logo
  1. Home
  2. Wheezing
  3. NCT04208360
  4. Details
NCT04208360 Clinical Trial

Clinical Evaluation of AI-aided Auscultation With Automatic Classification of Respiratory System Sounds

Wheezing Clinical Trial

— AIR  

Official title:
Clinical Evaluation of AI-aided Auscultation With Automatic Classification of Respiratory System Sounds

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04208360
Other study ID # StethoMe AIR
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2021
Est. completion date October 2021

Study information
Verified date October 2020
Source StethoMe
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the present trial, the StethoMe electronic stethoscope will be used for pulmonary auscultation and recording of lung sounds in the pediatric study population.

Description:

Multicenter, international - 2 EU sites (max. 1 in Poland) and a single US site. Trial centers and investigators will be identified and selected based on their clinical and research experience. The trial objective is to assess whether use of the StethoMe AI lung sounds analysis software provides clinical benefit by improving the identification of abnormal lung sounds in the categories of wheezes, rhonchi, fine crackles and coarse as compared to pulmonary auscultation by experienced physicians (general practitioners (GPs) and pulmonologists). The recordings will be used to form a gold standard database of lung sounds as evaluated by an expert, independent panel according to the study protocol. The gold standard database will include approximately equal representation of wheezes, rhonchi, fine crackles and coarse crackles. Moreover, the database will also include recordings without any of the previous descripted pathological sounds. The results of these two analyses, by traditional physician listening and by the StethoMe AI software application, will be assessed for sensitivity and specificity to the gold standard database in detection of the four lung sounds and recordings without defined pathological sounds. The StethoMe AI will be considered to provide clinical benefit if it demonstrates statistically better sensitivity or specificity on any of the four lung sounds as compared to the traditional physician auscultation, together with F1 score analysis.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 84
Est. completion date October 2021
Est. primary completion date August 2021
Accepts healthy volunteers No
Gender All
Age group 3 Months to 18 Years
Eligibility Inclusion Criteria: - Children between 3 months and 18 years old (inclusive) admitted and hospitalized in the pulmonary disease ward (PL and EU). - Children between 3 months and 18 years old (inclusive) admitted and hospitalized in the pulmonary disease ward or treated in an outpatient clinic (US). - Informed consent of parents or caregivers, according to local regulations. Exclusion Criteria: - Skin/soft tissue disease or local infection at the site of pulmonary auscultation or any other contraindication for the pulmonary auscultation. - Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• StethoMe stethoscope
Assessing whether use of the StethoMe AI lung sounds analysis software provides clinical benefit by improving the identification of abnormal lung sounds.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
StethoMe

Outcome
Type Measure Description Time frame Safety issue
Primary Collecting pulmonary auscultation recordings Sensitivity for detection of wheezes by StethoMe AI algorithms in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Sensitivity for detection of rhonchi by StethoMe AI algorithms in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Sensitivity for detection of coarse crackles by StethoMe AI algorithms in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Sensitivity for detection of fine crackles by StethoMe AI algorithms in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Specificity for detection of wheezes by StethoMe AI algorithms in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Specificity for detection of rhonchi by StethoMe AI algorithms in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Specificity for detection of coarse crackles by StethoMe AI algorithms in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Specificity for detection of fine crackles by StethoMe AI algorithms in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings F1 score for detection of wheezes by StethoMe AI algorithms in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings F1 score for detection of rhonchi by StethoMe AI algorithms in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings F1 score for detection of coarse crackles by StethoMe AI algorithms in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings F1 score for detection of fine crackles by StethoMe AI algorithms in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Sensitivity for detection of wheezes by pulmonologists in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Sensitivity for detection of rhonchi by pulmonologists in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Sensitivity for detection of coarse crackles by pulmonologists in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Sensitivity for detection of fine crackles by pulmonologists in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Specificity for detection of wheezes by pulmonologists in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Specificity for detection of rhonchi by pulmonologists in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Specificity for detection of coarse crackles by pulmonologists in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Specificity for detection of fine crackles by pulmonologists in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings F1 score for detection of wheezes by pulmonologists in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings F1 score for detection of rhonchi by pulmonologists in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings F1 score for detection of coarse crackles by pulmonologists in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings F1 score for detection of fine crackles by pulmonologists in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Sensitivity for detection of wheezes by general practitioners in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Sensitivity for detection of rhonchi by general practitioners in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Sensitivity for detection of coarse crackles by general practitioners in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Sensitivity for detection of fine crackles by general practitioners in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Specificity for detection of wheezes by general practitioners in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Specificity for detection of rhonchi by general practitioners in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Specificity for detection of coarse crackles by general practitioners in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings Specificity for detection of fine crackles by general practitioners in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings F1 score for detection of wheezes by general practitioners in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings F1 score for detection of rhonchi by general practitioners in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings F1 score for detection of coarse crackles by general practitioners in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings F1 score for detection of fine crackles by general practitioners in comparison to gold standard 24 hours
Primary Collecting pulmonary auscultation recordings - Possibility to perform pulmonary auscultation by physician by using study device with dedicated application, defined as a percentage of enrolled patients in whom the pulmonary auscultation was performed. 24 hours
See also
  Status Clinical Trial Phase
Recruiting NCT04669288 - AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department Phase 3
Withdrawn NCT04584034 - Bronchodilators for Wheeze in Young Children Presenting to Primary Care: a Randomised, Placebo-controlled, Multicentre, Parallel Group Trial Phase 4
Terminated NCT02269761 - Chest Ultrasound of ER Patients With Cough or SOB
Enrolling by invitation NCT00775697 - Montelukast in Children With Wheezing Phase 4
Completed NCT00749528 - Evaluation of Toxic Metals, Trace Elements and Total Antioxidant Activity in Children With Recurrent Wheezing N/A
Recruiting NCT00494624 - Efficacy of Systemic Glucocorticoid in the Treatment of Wheezing in Children Phase 4
Recruiting NCT04128592 - Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers N/A
Recruiting NCT06093152 - Video Assisted Study of Salbutamol Response in Viral Wheezing
Completed NCT01452945 - Bedside Lung Ultrasound in Young Children Presenting to the Emergency Department (ED) With Wheezing N/A
Withdrawn NCT00628303 - A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants Phase 3
Completed NCT01028560 - Allergy Immunotherapy for the Reduction of Asthma Phase 1/Phase 2
Completed NCT00626808 - A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children Phase 4
Completed NCT00507676 - Lung Function and Structure in Healthy Infants and Infants With Recurrent Wheezing N/A
Completed NCT03600428 - Safety of LAIV4 in Children With Asthma Phase 4
Recruiting NCT06106646 - Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
Recruiting NCT05710081 - Bacterial Lysate In Preventing Asthma Phase 3
Completed NCT04011709 - A Methodology Trial Using the VR647 Inhalation System in Pediatric Subjects Who Have Previously Received Inhaled Therapy Early Phase 1
Active, not recruiting NCT03377192 - Impedance Pneumography in Assessment of Asthma Control in Preschool Children
Completed NCT01142505 - Wheeze and Intermittent Treatment Phase 3
Active, not recruiting NCT04942483 - Using Specific Tests in Preschool Children With Wheeze to Help us Determine the Necessity of Inhaled Corticosteroid Therapy (Feasibility Study).