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Clinical Trials/NCT04752891
NCT04752891
Completed
Not Applicable

Assessment of an App Based on Artificial Intelligence for Purulent Acute Otitis Media (AOM) Diagnosis in a a Pediatric Emergency Department

Fondation Lenval1 site in 1 country203 target enrollmentJune 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Otitis Media, Suppurative
Sponsor
Fondation Lenval
Enrollment
203
Locations
1
Primary Endpoint
diagnosis of purulent Acute Otitis Media (AOM) made by junior physicians using the i-Nside application associated with Smartscope®
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Otitis media (OM) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . An artificial intelligence-based tool could help physicians refine their diagnosis

Detailed Description

Ear infections in children are very common, particularly acute otitis media (AOM) which represents the first reason for visiting physicians and for antibiotic prescription in children in developed countries. However, the diagnosis is not easy because of the narrowness of the ear canal, the discomfort of the child during the otoscopic exam. Moreover, the accuracy of the AOM diagnosis depends on the subjectivity of the physician mostly. This can result in an misdiagnosis and inappropriate treatment with, as a result, the emergence of multi-resistant germ. Artificial intelligence (AI) in medicine is booming and has already proven its worth in terms of prevention, monitoring and diagnosis. I-Nside, an app based on Artificial Intelligence is able to make automatic diagnosis of many ear pathologies, after capturing picture of any eardrum using an otoendoscope fixed on a connected smartphone (SmartScope®). Therefore, the investigators aim to assess the accuracy of AOM diagnosis the existing app, by comparing the inter-rater agreement between the diagnosis made by a senior physician using a traditional otoscope (considered as "gold standard" ) and the one made by a junior physician using the app

Registry
clinicaltrials.gov
Start Date
June 10, 2021
End Date
March 16, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Fondation Lenval
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Child under 18 years Presenting signs that may suggest acute otitis media (fever, earache, purulent otorrhea) For which the informed written consent of, at least, one of the two parents or the holder of parental authority has been obtained

Exclusion Criteria

  • A sign (s) of vital distress Trans-tympanic drains

Outcomes

Primary Outcomes

diagnosis of purulent Acute Otitis Media (AOM) made by junior physicians using the i-Nside application associated with Smartscope®

Time Frame: at inclusion

diagnosis of purulent AOM is made on an inflammatory aspect of the eardrum with retrotympanic effusion, exteriorized (otorrhea) or not (opacity, effacement of reliefs or bulging, disappearance of the light triangle).

diagnosis of purulent Acute Otitis Media (AOM) made by senior physicians using a standard otoscope

Time Frame: at inclusion

diagnosis of purulent AOM is made on an inflammatory aspect of the eardrum with retrotympanic effusion, exteriorized (otorrhea) or not (opacity, effacement of reliefs or bulging, disappearance of the light triangle)

Secondary Outcomes

  • rate of misdiagnoses of purulent Acute Otitis Media (AOM) with and without the use of the application(at inclusion)
  • satisfaction of junior physicians regarding the use of the app(through study completion, an average of 1 year)
  • collection risk factors for a discrepancy in the diagnosis of purulent AOM(at inclusion)

Study Sites (1)

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