Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy

Overview

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.

Full Title of Study: “Evaluation of Office-Based Sheathed Flexible Nasopharyngoscopy: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Single (Outcomes Assessor)

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

Interventions

  • Device: Endosheath
    • Flexible sheathed nasopharyngolaryngoscopy

Arms, Groups and Cohorts

  • No Intervention: Traditional flexible nasopharyngolaryngoscopy
    • No sheath procedure
  • Active Comparator: Sheath flexible nasopharyngolaryngoscopy
    • Flexible nasopharyngolaryngoscopy using endosheath

Clinical Trial Outcome Measures

Primary Measures

  • Patient pain and discomfort
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 17 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Alberta
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr. Allan Ho, Principal Investigator, University of Alberta

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