Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy
Overview
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.
Full Title of Study: “Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy: A Randomized Controlled Trial”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
Detailed Description
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 Cost-analysis Comparison: No-sheath flexible nasopharyngoscopy versus sheathed flexible nasopharyngoscopy
Interventions
- Device: Endosheath
- Flexible sheathed nasopharyngolaryngoscopy
Arms, Groups and Cohorts
- No Intervention: Traditional flexible nasopharyngolaryngoscopy
- No sheath procedure
- Active Comparator: Sheath flexible nasopharyngolaryngoscopy
- Flexible nasopharyngolaryngoscopy using endosheath
Clinical Trial Outcome Measures
Primary Measures
- Patient pain and discomfort
- Time Frame: 1 hour
- 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
Secondary Measures
- Physician and staff satisfaction
- Time Frame: 1 week
- Physician and support staff satisfaction with easy and efficiency of sheathed scopes.
- Optical quality
- Time Frame: 1 hour
- Image quality of flexible endoscopy with or without endosheath.
Participating in This Clinical Trial
Inclusion Criteria
- Adult patients presenting to the Otolaryngology-Head and Neck Surgery service with complaints warranting flexible endoscopy Exclusion Criteria:
- Known sinonasal masses or nasal polyposis – Unable to complete VAS surveys – Significant septal deviation – Unable to tolerate in-office flexible nasopharyngoscopy – Patients who refuse consent
Gender Eligibility: All
Minimum Age: 17 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- University of Alberta
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Dr. Allan Ho, Principal Investigator, University of Alberta
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