Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy

Not Applicable

Withdrawn

• Conditions: Otorhinolaryngologic Diseases
• Interventions: Device: Endosheath

• Registration Number: NCT01669278
• Lead Sponsor: University of Alberta

Brief Summary

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.

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

Study Timeline

• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-08-17
• Study First Posted: 2012-08-20
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-14
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sheath flexible nasopharyngolaryngoscopy	Endosheath	Flexible nasopharyngolaryngoscopy using endosheath

Primary Outcome Measures

Name	Time	Method
Patient pain and discomfort	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 Outcome Measures

Name	Time	Method
Physician and staff satisfaction	1 week	Physician and support staff satisfaction with easy and efficiency of sheathed scopes.
Optical quality	1 hour	Image quality of flexible endoscopy with or without endosheath.

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada