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

History of Changes

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 May 16, 2013

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