N/A
Completed N=22
Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
Acute otitis media · Acute Otitis Externa
Source: ClinicalTrials.gov NCT02918773 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Number of Antibiotic Prescriptions — 140; 115; 6; 7 Emergency department encounters
Summary
Acute otitis media (AOM), defined as acute inflammation in the middle ear, is a leading cause of health encounters and antimicrobial prescriptions in children worldwide. Diagnosis of AOM is often dependent on a brief view of the tympanic membrane in an uncooperative child's ear canal. As a consequence, AOM may be inappropriately diagnosed when visualization of the tympanic membrane (ear drum) is not optimal. Improved methods for visualizing the tympanic membrane including capturing still images and recording video of the ear exam would be beneficial in the diagnosis and management of otic complaints, including acute and chronic otitis media. Use of a smartphone otoscope has the potential to optimize clinician ability to manage otic complaints, visualize the tympanic membrane, and support antimicrobial stewardship. This study will be conducted as a randomized control study in two affiliated children's hospital emergency departments. Twenty volunteer clinicians will be randomly assigned to use either a smartphone otoscope or a conventional otoscope for all otic examinations for a 6-month period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Antibiotic Prescriptions |
140; 115; 6; 7; 0; 1 | — |
| SECONDARY Number of Diagnoses of Acute Otitis Media (AOM) |
146; 123; 630; 491 | — |
| SECONDARY Number of Diagnoses of Otitis Externa |
0; 0; 776; 614 | — |
| SECONDARY Clinician Acceptability of the Smartphone Otoscopic Device |
8; 3; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must be a pediatric emergency care clinicians providing care at an emergency department a participating children's hospital
- Willing to agree to random assignment to either a smartphone otoscope device or a conventional otoscope device for the 6-month study period
- Willing to log patient encounters that included the an otoscopic examination for non-traumatic indication for each shift
- Willing to document and report episodes of care in which the assigned otoscopic device could not be used on a study-eligible otoscopic examination
- Willing to complete an end of study assessment, if assigned to use the smartphone otoscope
Exclusion Criteria
- Declines to give informed consent to participate in the study
Data sourced from ClinicalTrials.gov (NCT02918773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.