Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy

This study is not yet open for participant recruitment.
Verified August 2012 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01669278
First received: August 7, 2012
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

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 Intervention
Otorhinolaryngologic Diseases
Device: Endosheath

Study Type: Interventional
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

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 76
Study Start Date: September 2012
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Traditional flexible nasopharyngolaryngoscopy
No sheath procedure
Active Comparator: Sheath flexible nasopharyngolaryngoscopy
Flexible nasopharyngolaryngoscopy using endosheath
Device: Endosheath
Flexible sheathed nasopharyngolaryngoscopy

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

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01669278

Contacts
Contact: Dr. Allan Ho, MD (780)435-7113

Locations
Canada, Alberta
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6H 2H7
Contact: Dr. Allan Ho, MD    (780) 435-7113      
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Dr. Allan Ho University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01669278     History of Changes
Other Study ID Numbers: UA-Endo001
Study First Received: August 7, 2012
Last Updated: August 17, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
sheath
flexible
endoscopy
otolaryngology
office

Additional relevant MeSH terms:
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014