Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy
The processing of standard flexible nasopharyngoscopes is a time-consuming and costly process. The goal of this study is to determine the efficiency and cost-effectiveness of sheathed flexible endoscope in an office setting.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
|Official Title:||Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy: A Randomized Controlled Trial|
- Patient pain and discomfort [ Time Frame: 1 hour ] [ Designated as safety issue: No ]Patient Pain and Discomfort i. Patient's reported level of pain based on International Association for the Study of Pain definitions of pain on a 100-mm Visual Analogue Scale ii. Patient's reported level of discomfort on a 100-mm Visual Analogue Scale
- Physician and staff satisfaction [ Time Frame: 1 week ] [ Designated as safety issue: No ]Physician and support staff satisfaction with easy and efficiency of sheathed scopes.
- Optical quality [ Time Frame: 1 hour ] [ Designated as safety issue: No ]Image quality of flexible endoscopy with or without endosheath.
|Study Start Date:||September 2012|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
No Intervention: Traditional flexible nasopharyngolaryngoscopy
No sheath procedure
Active Comparator: Sheath flexible nasopharyngolaryngoscopy
Flexible nasopharyngolaryngoscopy using endosheath
Flexible sheathed nasopharyngolaryngoscopy
Methods: Randomized, single-blinded, controlled trial
Setting: Office practice of two academic otolaryngologists at a community hospital.
Primary Outcomes: Patient pain and discomfort, Optical quality
Secondary Outcomes: Physician and nursing staff satisfaction
Comparison: No-sheath flexible nasopharyngoscopy versus sheathed flexible nasopharyngoscopy
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669278
|Contact: Dr. Allan Ho, MD||(780)435-7113|
|University of Alberta||Not yet recruiting|
|Edmonton, Alberta, Canada, T6H 2H7|
|Contact: Dr. Allan Ho, MD (780) 435-7113|
|Principal Investigator:||Dr. Allan Ho||University of Alberta|