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Completed

NCT Number: NCT04752891

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

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

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Key information

Conditions

Otitis Media, Suppurative Ear Diseases Infections Otitis Otitis Media Otorhinolaryngologic Diseases Suppuration

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Pédiatrique de Nice CHU Lenval

Nice, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

AOM diagnosis with app

Other

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

Other

the diagnosis made by a senior physician and by the junior physician, using a traditional otoscope

Primary outcomes

  1. 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).

  2. 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

  1. rate of misdiagnoses of purulent Acute Otitis Media (AOM) with and without the use of the application

    Time frame: at inclusion

    a misdiagnosis is measured by a discordant diagnosis of the juniors compared to the seniors considered as the Gold Standard for the AOM diagnosis

  2. collection risk factors for a discrepancy in the diagnosis of purulent AOM

    Time frame: at inclusion

    collection data of age of patients,pain requiring analgesia, period of the day of diagnosis (morning, afternoon,night)

  3. satisfaction of junior physicians regarding the use of the app

    Time frame: through study completion, an average of 1 year

    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

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Official study title

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

Acronym: OMA-IA

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 12, 2021
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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