search
Back to results

Mobile Otoscopy - Efficacy of Residents to Diagnose Acute Otitis Media Using a Smartphone Otoscope Attachment (MOTO)

Primary Purpose

Acute Otitis Media

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cellscope
Traditional otoscope
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Otitis Media

Eligibility Criteria

1 Year - 4 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Visiting the ED for fever and respiratory problems
  • During the hours when there is a research assistant

Exclusion Criteria:

  • 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)

Sites / Locations

  • Sainte-Justine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cellscope

Traditional otoscope

Arm Description

The intervention for this study will be the use of a smartphone otoscope attachment called CellScope Oto.

The control group will be using a classic otoscope

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Need for second exam
The number of participants for which the staff in charge will have to repeat the exam
Parents satisfaction
The parents' satisfaction regarding the ear exam performed on their child using a likert scale
Confidence
the confidence of participants in their ear exams using a likert scale

Full Information

First Posted
August 7, 2015
Last Updated
October 12, 2016
Sponsor
St. Justine's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02521597
Brief Title
Mobile Otoscopy - Efficacy of Residents to Diagnose Acute Otitis Media Using a Smartphone Otoscope Attachment
Acronym
MOTO
Official Title
Mobile Otoscopy - Efficacy of Residents to Diagnose Acute Otitis Media Using a Smartphone Otoscope Attachment: A Randomized Controlled Trials
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Justine's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background: Acute otitis media (AOM) is one of the most common diseases of childhood and a leading cause for health care consultations. While otoscope is the tool traditionally used to diagnose AOM, otoscopic diagnostic skills of both trainees and practitioners appear to be limited. Therefore, new diagnostic methods are continuously developed. One of those devices is a smartphone otoscope attachment called CellScope Oto, a portable video-otoscope that allows residents and staff to share diagnostic-quality images. Objective: 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. Methods: This will be a randomized controlled trial evaluating accuracy of evaluation of ears of children visiting the emergency department (ED) for suspected AOM by residents using the CellScope Oto in comparison to a classic otoscope. It will be performed at a single pediatric ED in a tertiary care Hospital. Participants will be children between 1 and 5 years of age presenting with fever and respiratory symptoms. Baselines characteristics of participants will be assessed. Participating residents will be taught how to use the CellScope Oto and will practice with a few patients before being ready to participate in the study. Eligible patients will be recruited during weekdays. If the parents consent, patients will first be evaluated by a staff Pediatric Otolaryngologist using a binocular microscope (gold standard). They will then be evaluated by two participating residents, one using the intervention method and one using the control. Randomization will be used to decide which visualisation method will be used first. After all three exams have been performed, the residents, patients' parent and staff in charge will each be asked to answer a short questionnaire about final diagnosis and confidence in the performed exam, favourite method and the need for a control exam. These questionnaires will be reviewed by a reviewer blinded to the randomization. The primary outcome measure will be the accuracy of AOM diagnosis made by the residents compared with the diagnosis made by a staff Pediatric Otolaryngologist using a binocular microscope. A sample size of 100 participants evaluated twice would provide a power of 80% and an alpha value of 0,05 to demonstrate a difference of 15% in the rate of appropriate diagnosis of AOM by residents using a smartphone otoscope attachment compared with classic otoscope use. Expected results: The investigators expect to demonstrate a 15% increase in the efficacy rate of AOM diagnosis by residents registered to a paediatrics-related program using a smartphone otoscope attachment compared with a classic otoscope. This device has the potential to change current AOM diagnostic practice and might, in turn, provide a reduced amount of prescriptions made every year for antibiotics.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cellscope
Arm Type
Experimental
Arm Description
The intervention for this study will be the use of a smartphone otoscope attachment called CellScope Oto.
Arm Title
Traditional otoscope
Arm Type
Active Comparator
Arm Description
The control group will be using a classic otoscope
Intervention Type
Device
Intervention Name(s)
Cellscope
Intervention Description
The CellScope Oto, is a portable video-otoscope that allows residents and staff to share diagnostic-quality images
Intervention Type
Device
Intervention Name(s)
Traditional otoscope
Intervention Description
Use of a regular otoscope
Primary Outcome Measure Information:
Title
accuracy in diagnosing acute otitis media
Description
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.
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Need for second exam
Description
The number of participants for which the staff in charge will have to repeat the exam
Time Frame
15 minutes
Title
Parents satisfaction
Description
The parents' satisfaction regarding the ear exam performed on their child using a likert scale
Time Frame
30 minutes
Title
Confidence
Description
the confidence of participants in their ear exams using a likert scale
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Visiting the ED for fever and respiratory problems During the hours when there is a research assistant Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn Gravel, MD, MSc
Organizational Affiliation
St. Justine's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sainte-Justine Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1C5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
29544905
Citation
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.
Results Reference
derived

Learn more about this trial

Mobile Otoscopy - Efficacy of Residents to Diagnose Acute Otitis Media Using a Smartphone Otoscope Attachment

We'll reach out to this number within 24 hrs