RecruitingNCT05318599

Deep Learning Diagnostic and Risk-stratification for IPF and COPD

Deep Learning Diagnostic and Risk-stratification for Idiopathic Pulmonary Fibrosis and Chronic Obstructive Pulmonary Disease in Digital Lung Auscultations


Sponsor

Pediatric Clinical Research Platform

Enrollment

160 participants

Start Date

Apr 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonia (NSIP), and chronic obstructive pulmonary disease (COPD) are severe, progressive, irreversibly incapacitating pulmonary disorders with modest response to therapeutic interventions and poor prognosis. Prompt and accurate diagnosis is important to enable patients to receive appropriate care at the earliest possible stage to delay disease progression and prolong survival. Artificial intelligence (AI)-assisted digital lung auscultation could constitute an alternative to conventional subjective operator-related auscultation to accurately and earlier diagnose these diseases. Moreover, lung ultrasound (LUS), a relevant gold standard for lung pathology, could also benefit from automation by deep learning.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • Written informed consent
  • age \> 18 years old.
  • patients with already-diagnosed IPF (group 1) prior to the consultation (index) date.
  • patients with already-diagnosed NSIP (group 2) prior to the consultation (index) date.
  • patients with already-diagnosed COPD (group 3) prior to the consultation (index) date.
  • Control subjects must be followed-up at the pulmonology outpatient clinic for:
  • obstructive sleep apnoea.
  • occupational lung diseases (miners, chemical workers, etc.).
  • pulmonary nodules (considered benign after 2 years).

Exclusion Criteria7

  • patients who cannot be mobilized for posterior auscultation.
  • patients known for severe cardiovascular disease with pulmonary repercussion.
  • patients known for a concurrent, acute, infectious pulmonary disease (e.g., pneumonia, bronchitis).
  • patients known for asthma.
  • patients known or suspected of immunodeficiency, alpha-1-antitrypsin deficit, and or under immunotherapy.
  • patients with physical inability to follow procedures.
  • patients with inability to give informed consent.

Interventions

DEVICELung auscultation

Digital lung auscultation with the Eko core digital stethoscope (Eko Devices, Inc., CA, USA).

DEVICELung ultrasound

Lung ultrasonography

OTHERQuality of Life's questionnaires

Impact of the diseases on subjects' health-related quality of life measured with standardized questionnaires (K-BILD, CAT)

DIAGNOSTIC_TESTPulmonary functional tests

Spirometry, body-plethysmographic parameters and lung diffusion capacity for carbon monoxide will be measured.


Locations(1)

Centre Hospitalier du Valais Romand

Sion, Valais, Switzerland

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NCT05318599


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