Ignite Creation Date:
2024-05-06 @ 9:09 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02918773
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2016-09-28
Brief Title:
Pediatric Emergency Department Smartphone Otoscope Study PED-Oto
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Pediatric Emergency Department Smartphone Otoscope Study PED-Oto
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 childs 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 childrens 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
Detailed Description:
A smartphone otoscope CellScope-Oto is a pocket size attachment that employs the technology and light source of a smartphone to capture reproducible images of the ear canal and tympanic membrane Previous studies with this device demonstrated that images taken with both the smartphone otoscope and a camera-fitted conventional analogue otoscope were equivalent with respect to image quality and that the smartphone otoscope was acceptable as an educational and diagnostic tool to health professional students A pilot study with a similar design to this study conducted in two offices of an ambulatory pediatric clinic demonstrated a trend toward decreased antimicrobial prescription filling among families whose children were examined with the smartphone otoscope compared to those who were examined with a conventional otoscope To further assess this trend this study proposes an evaluation of the impact of device use on antimicrobial prescribing for children with an otic complaint in a pediatric emergency department PED setting This study will enroll 20 clinicians for the 6-month study period 10 who will be randomly assigned to use a smartphone otoscope for the 6-month study period and 10 who will be assigned to use a conventional otoscope for all otoscopic exams Data will be abstracted via retrospective review of the electronic medical record of encounters in with an otoscopic exam was performed as part of the diagnostic evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None