Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by University of Alberta.
Recruitment status was  Not yet recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 20, 2014