Clinical trial NCT04752891: Assessment of an App Based on Artificial Intelligence for Purulent AOM Diagnosis in a Pediatric Department
Official title: Assessment of an App Based on Artificial Intelligence for Purulent Acute Otitis Media (AOM) Diagnosis in a a Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media, Suppurative
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 203
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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

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

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Primary outcomes:
measure: diagnosis of purulent Acute Otitis Media (AOM) made by junior physicians using the i-Nside application associated with Smartscope®
timeFrame: at inclusion
measure: diagnosis of purulent Acute Otitis Media (AOM) made by senior physicians using a standard otoscope
timeFrame: at inclusion
Secondary outcomes:
measure: rate of misdiagnoses of purulent Acute Otitis Media (AOM) with and without the use of the application
timeFrame: at inclusion
measure: collection risk factors for a discrepancy in the diagnosis of purulent AOM
timeFrame: at inclusion
measure: satisfaction of junior physicians regarding the use of the app
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpitaux Pédiatrique de Nice CHU Lenval
Study officials:
References: