Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy

• Sponsor: University of Alberta (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01669278
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Otorhinolaryngologic Diseases	Device: Endosheath	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Official Title: Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy: A Randomized Controlled Trial

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Traditional flexible nasopharyngolaryngoscopy No sheath procedure
Active Comparator: Sheath flexible nasopharyngolaryngoscopy Flexible nasopharyngolaryngoscopy using endosheath	Device: Endosheath; Flexible sheathed nasopharyngolaryngoscopy

Outcome Measures

Primary Outcome Measures

1. 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

1. Physician and staff satisfaction [1 week]

   Physician and support staff satisfaction with easy and efficiency of sheathed scopes.

2. Optical quality [1 hour]

   Image quality of flexible endoscopy with or without endosheath.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta	Edmonton	Alberta	Canada	T6H 2H7

Sponsors and Collaborators

• University of Alberta

Investigators

• Principal Investigator: Dr. Allan Ho, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT01669278
• Other Study ID Numbers: UA-Endo001
• First Posted: Aug 20, 2012
• Last Update Posted: Sep 16, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by University of Alberta: sheath; flexible; endoscopy; otolaryngology; office
• Additional relevant MeSH terms: Otorhinolaryngologic Diseases

Study Results

No Results Posted as of Sep 16, 2016