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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
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