Assessment of an App Based on Artificial Intelligence for Purulent AOM Diagnosis in a Pediatric Department

Otitis Media, Suppurative Clinical Trial

— OMA-IA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752891
• Other study ID #: 20-HPNCL-07
• Status: Completed
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: March 16, 2023

Study information

• Verified date: March 2023
• Source: Fondation Lenval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: March 16, 2023
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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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Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media, Suppurative

Intervention

Other:
• AOM diagnosis with app
the diagnosis made by a senior physician using a traditional otoscope. the diagnosis made by the junior physician using an otoendoscope fixed on a connected smartphone
• AOM diagnosis without app
the diagnosis made by a senior physician and by the junior physician, using a traditional otoscope

Locations

Country	Name	City	State
France	Hôpitaux Pédiatrique de Nice CHU Lenval	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis of purulent Acute Otitis Media (AOM) made by junior physicians using the i-Nside application associated with Smartscope®	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).	at inclusion
Primary	diagnosis of purulent Acute Otitis Media (AOM) made by senior physicians using a standard otoscope	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)	at inclusion
Secondary	rate of misdiagnoses of purulent Acute Otitis Media (AOM) with and without the use of the application	a misdiagnosis is measured by a discordant diagnosis of the juniors compared to the seniors considered as the Gold Standard for the AOM diagnosis	at inclusion
Secondary	collection risk factors for a discrepancy in the diagnosis of purulent AOM	collection data of age of patients,pain requiring analgesia, period of the day of diagnosis (morning, afternoon,night)	at inclusion
Secondary	satisfaction of junior physicians regarding the use of the app	a questionnaire will be given at the end of the study. The questions relate to the use of the application and its perceived usefulness by practitioners. Satisfaction will be assessed by a Lickert scale	through study completion, an average of 1 year