Mobile Otoscopy - Efficacy of Residents to Diagnose Acute Otitis Media Using a Smartphone Otoscope Attachment
MOTO
1 other identifier
interventional
100
1 country
1
Brief Summary
To evaluate the residents' efficacy in diagnosing acute otitis media among febrile children presenting with respiratory symptoms using a smartphone otoscope attachment compared with a classic otoscope.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 7, 2015
CompletedFirst Posted
Study publicly available on registry
August 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedOctober 13, 2016
October 1, 2016
10 months
August 7, 2015
October 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
accuracy in diagnosing acute otitis media
This will be the number of participants for which there will be a complete agreement between the evaluation of the resident and the diagnosis of acute otitis media as diagnosed by the Pediatric Otolaryngologist using binocular microscope.
15 minutes
Secondary Outcomes (3)
Need for second exam
15 minutes
Parents satisfaction
30 minutes
Confidence
15 minutes
Study Arms (2)
Cellscope
EXPERIMENTALThe intervention for this study will be the use of a smartphone otoscope attachment called CellScope Oto.
Traditional otoscope
ACTIVE COMPARATORThe control group will be using a classic otoscope
Interventions
The CellScope Oto, is a portable video-otoscope that allows residents and staff to share diagnostic-quality images
Eligibility Criteria
You may qualify if:
- Visiting the ED for fever and respiratory problems
- During the hours when there is a research assistant
You may not qualify if:
- Anterior myringotomy with tube placement
- Signs of serious infection (triage priority 1 or 2, tachycardia and/or hypotension, bulging fontanelle, neck stiffness, purpuric rash, altered consciousness)
- Impossibility to obtain an informed consent by the parent (absence of parent, language barrier, etc)
- Severe chronic illness (immunodeficiency, congenital heart disease, encephalopathy, pulmonary disease other than asthma, and disorder of the ear, nose and throat)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sainte-Justine Hospital
Montreal, Quebec, H3T1C5, Canada
Related Publications (1)
Mousseau S, Lapointe A, Gravel J. Diagnosing acute otitis media using a smartphone otoscope; a randomized controlled trial. Am J Emerg Med. 2018 Oct;36(10):1796-1801. doi: 10.1016/j.ajem.2018.01.093. Epub 2018 Jan 31.
PMID: 29544905DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jocelyn Gravel, MD, MSc
St. Justine's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc
Study Record Dates
First Submitted
August 7, 2015
First Posted
August 13, 2015
Study Start
August 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
October 13, 2016
Record last verified: 2016-10