Acute Otitis MediaMOTONCT02521597
Mobile Otoscopy - Efficacy of Residents to Diagnose Acute Otitis Media Using a Smartphone Otoscope Attachment
A study testing Cellscope and Traditional otoscope in people with Acute Otitis Media, run by St. Justine's Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 4 years
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- Cellscope and Traditional otoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Visiting the ED for fever and respiratory problems
- During the hours when there is a research assistant
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile Otoscopy - Efficacy of Residents to Diagnose Acute Otitis Media Using a Smartphone Otoscope Attachment: A Randomized Controlled Trials
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.
Read the 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.
- Conditions
- Acute Otitis Media
- Being tested
- Cellscope, Traditional otoscope
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CellscopeDevice
The CellScope Oto, is a portable video-otoscope that allows residents and staff to share diagnostic-quality images
Traditional otoscopeDevice
Use of a regular otoscope
| Study group | Role | What they receive |
|---|---|---|
| Cellscope | Experimental | The intervention for this study will be the use of a smartphone otoscope attachment called CellScope Oto. Receives: Device: Cellscope |
| Traditional otoscope | Active comparator | The control group will be using a classic otoscope Receives: Device: Traditional otoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Secondary outcomes (3)
Need for second exam
The number of participants for which the staff in charge will have to repeat the exam
Measured: 15 minutes
Parents satisfaction
The parents' satisfaction regarding the ear exam performed on their child using a likert scale
Measured: 30 minutes
Confidence
the confidence of participants in their ear exams using a likert scale
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyn Gravel, St. Justine's Hospital
- Investigators
- Jocelyn Gravel, MD, MSc, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521597
- Sponsor's protocol ID
- MOTO study
- Acronym
- MOTO
- Status last verified
- Oct 2016
- First submitted
- 7 Aug 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29544905
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Otoscopy - Efficacy of Residents to Diagnose Acute Otitis Media Using a Smartphone Otoscope Attachment: A Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT02521597
- Acronym / sponsor ID
- MOTO / MOTO study
- Conditions
- Acute Otitis Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cellscope | Experimental | Device: CellscopeThe intervention for this study will be the use of a smartphone otoscope attachment called CellScope Oto. |
| Traditional otoscope | Active comparator | Device: Traditional otoscopeThe control group will be using a classic otoscope |
Who may qualify
- Ages
- 1 year to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Visiting the ED for fever and respiratory problems
- During the hours when there is a research assistant
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CellscopeThe CellScope Oto, is a portable video-otoscope that allows residents and staff to share diagnostic-quality images | Device | Cellscope |
| Traditional otoscopeUse of a regular otoscope | Device | Traditional otoscope |
Primary outcome
accuracy in diagnosing acute otitis media
Time frame: 15 minutes
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.
3 secondary outcomes
Need for second exam
Time frame: 15 minutes
Parents satisfaction
Time frame: 30 minutes
Confidence
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Derived from this study: PubMed 29544905Mousseau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jocelyn Gravel, MD, MSc principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cellscope and Traditional otoscope in people with Acute Otitis Media, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy in diagnosing acute otitis media (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02521597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2016.