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

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ClinicalTrials.gov Identifier: NCT04208360
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
StethoMe

Brief 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.

Condition or disease Intervention/treatment
Wheezing Rhonchi Crackle Lung Sound Device: StethoMe stethoscope

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Evaluation of AI-aided Auscultation With Automatic Classification of Respiratory System Sounds
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Sensitivity for detection of wheezes by StethoMe AI algorithms in comparison to gold standard

  2. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Sensitivity for detection of rhonchi by StethoMe AI algorithms in comparison to gold standard

  3. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Sensitivity for detection of coarse crackles by StethoMe AI algorithms in comparison to gold standard

  4. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Sensitivity for detection of fine crackles by StethoMe AI algorithms in comparison to gold standard

  5. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Specificity for detection of wheezes by StethoMe AI algorithms in comparison to gold standard

  6. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Specificity for detection of rhonchi by StethoMe AI algorithms in comparison to gold standard

  7. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Specificity for detection of coarse crackles by StethoMe AI algorithms in comparison to gold standard

  8. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Specificity for detection of fine crackles by StethoMe AI algorithms in comparison to gold standard

  9. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    F1 score for detection of wheezes by StethoMe AI algorithms in comparison to gold standard

  10. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    F1 score for detection of rhonchi by StethoMe AI algorithms in comparison to gold standard

  11. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    F1 score for detection of coarse crackles by StethoMe AI algorithms in comparison to gold standard

  12. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    F1 score for detection of fine crackles by StethoMe AI algorithms in comparison to gold standard

  13. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Sensitivity for detection of wheezes by pulmonologists in comparison to gold standard

  14. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Sensitivity for detection of rhonchi by pulmonologists in comparison to gold standard

  15. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Sensitivity for detection of coarse crackles by pulmonologists in comparison to gold standard

  16. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Sensitivity for detection of fine crackles by pulmonologists in comparison to gold standard

  17. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Specificity for detection of wheezes by pulmonologists in comparison to gold standard

  18. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Specificity for detection of rhonchi by pulmonologists in comparison to gold standard

  19. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Specificity for detection of coarse crackles by pulmonologists in comparison to gold standard

  20. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Specificity for detection of fine crackles by pulmonologists in comparison to gold standard

  21. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    F1 score for detection of wheezes by pulmonologists in comparison to gold standard

  22. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    F1 score for detection of rhonchi by pulmonologists in comparison to gold standard

  23. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    F1 score for detection of coarse crackles by pulmonologists in comparison to gold standard

  24. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    F1 score for detection of fine crackles by pulmonologists in comparison to gold standard

  25. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Sensitivity for detection of wheezes by general practitioners in comparison to gold standard

  26. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Sensitivity for detection of rhonchi by general practitioners in comparison to gold standard

  27. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Sensitivity for detection of coarse crackles by general practitioners in comparison to gold standard

  28. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Sensitivity for detection of fine crackles by general practitioners in comparison to gold standard

  29. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Specificity for detection of wheezes by general practitioners in comparison to gold standard

  30. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Specificity for detection of rhonchi by general practitioners in comparison to gold standard

  31. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Specificity for detection of coarse crackles by general practitioners in comparison to gold standard

  32. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    Specificity for detection of fine crackles by general practitioners in comparison to gold standard

  33. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    F1 score for detection of wheezes by general practitioners in comparison to gold standard

  34. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    F1 score for detection of rhonchi by general practitioners in comparison to gold standard

  35. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    F1 score for detection of coarse crackles by general practitioners in comparison to gold standard

  36. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    F1 score for detection of fine crackles by general practitioners in comparison to gold standard

  37. Collecting pulmonary auscultation recordings [ Time Frame: 24 hours ]
    - 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
It is planned to enroll 84 patients into the trial in three trial centers that will be participating in the study. Each center should recruit approximately 33% of study recordings (25-30 patients).
Criteria

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.
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Responsible Party: StethoMe
ClinicalTrials.gov Identifier: NCT04208360    
Other Study ID Numbers: StethoMe AIR
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms