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Assessment of an App Based on Artificial Intelligence for Purulent AOM Diagnosis in a Pediatric Department (OMA-IA)

Primary Purpose

Otitis Media, Suppurative

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AOM diagnosis with app
AOM diagnosis without app
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Otitis Media, Suppurative

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

-

Sites / Locations

  • Hôpitaux Pédiatrique de Nice CHU Lenval

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

AOM diagnosis with app

AOM diagnosis without app

Arm Description

Outcomes

Primary Outcome Measures

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).
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)

Secondary Outcome Measures

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
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)
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

Full Information

First Posted
February 2, 2021
Last Updated
March 16, 2023
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT04752891
Brief Title
Assessment of an App Based on Artificial Intelligence for Purulent AOM Diagnosis in a Pediatric Department
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
August 16, 2022 (Actual)
Study Completion Date
March 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media, Suppurative

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AOM diagnosis with app
Arm Type
Experimental
Arm Title
AOM diagnosis without app
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
AOM diagnosis with app
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
AOM diagnosis without app
Intervention Description
the diagnosis made by a senior physician and by the junior physician, using a traditional otoscope
Primary Outcome Measure Information:
Title
diagnosis of purulent Acute Otitis Media (AOM) made by junior physicians using the i-Nside application associated with Smartscope®
Description
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).
Time Frame
at inclusion
Title
diagnosis of purulent Acute Otitis Media (AOM) made by senior physicians using a standard otoscope
Description
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)
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
rate of misdiagnoses of purulent Acute Otitis Media (AOM) with and without the use of the application
Description
a misdiagnosis is measured by a discordant diagnosis of the juniors compared to the seniors considered as the Gold Standard for the AOM diagnosis
Time Frame
at inclusion
Title
collection risk factors for a discrepancy in the diagnosis of purulent AOM
Description
collection data of age of patients,pain requiring analgesia, period of the day of diagnosis (morning, afternoon,night)
Time Frame
at inclusion
Title
satisfaction of junior physicians regarding the use of the app
Description
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
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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 -
Facility Information:
Facility Name
Hôpitaux Pédiatrique de Nice CHU Lenval
City
Nice
Country
France

12. IPD Sharing Statement

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

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