Nasal Dilator Strips for Rhinoplasty

Not Applicable

Withdrawn

• Conditions: Nasal Valve Compromise
• Interventions: Device: Breathe-Rite Nasal Dilator Strip

• Registration Number: NCT02787421
• Lead Sponsor: Emory University

Brief Summary

In this study, the study team will investigate the validity and role of nasal dilator strips (NDS), a novel method to determine the site of nasal valve compromise (NVC), in the pre-operative evaluation. The method involves placing the strip sequentially at the upper and lower lateral cartilage and recording the location of the optimal airway based on patient's subjective symptoms.

Investigators seek to assess surgical outcomes in participants undergoing rhinoplasty based on pre-operative NDS classification. The Nasal Obstruction and Septoplasty Effectiveness (NOSE) instrument will be used to evaluate subjective symptoms of nasal obstruction, before and after the operation and comparing these scores.The results will help determine the effectiveness and predictive value of NDS in isolating the site of NVC.

Detailed Description

In this study, the study team will investigate the validity and role of nasal dilator strips (NDS), a novel method to determine the site of nasal valve compromise (NVC), in the pre-operative evaluation. The method involves placing the strip sequentially at the upper and lower lateral cartilage and recording the location of the optimal airway based on patient's subjective symptoms.

Investigators seek to assess surgical outcomes in participants undergoing rhinoplasty based on pre-operative NDS classification. The Nasal Obstruction and Septoplasty Effectiveness (NOSE) instrument will be used to evaluate subjective symptoms of nasal obstruction, before and after the operation and comparing these scores.The results will help determine the effectiveness and predictive value of NDS in isolating the site of NVC.

Additional study aims are to determine the specificity and predictive value of nasal dilator strips in determining the location of obstruction in patients with nasal valve compromise, and to assess the role of nasal dilator strips in supplementing or replacing current approaches for pre-operative evaluation of nasal valve compromise.

The target population for this study is patients at the Emory Aesthetics Center who are undergoing functional rhinoplasty for nasal valve compromise and obstruction.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-26
• Study First Posted: 2016-06-01
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-06-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patient undergoing functional rhinoplasty for nasal valve compromise and obstruction at the Emory Aesthetics Center

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Exclusion Criteria

• Inability to speak English
• Any disabilities that might prevent patients from completing a survey

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functional Rhinoplasty	Breathe-Rite Nasal Dilator Strip	Participants undergoing functional rhinoplasty for nasal valve compromise and obstruction at the Emory Aesthetics Center.

Primary Outcome Measures

Name	Time	Method
Change in Nasal Obstruction and Septoplasty Effectiveness (NOSE) Instrument Score	Prior to surgery and again at 6-10 weeks after surgery	The NOSE instrument is a highly sensitive assessment of nasal obstruction using participant-reported subjective symptoms. The highest possible score is 100. A higher score indicates more severe nasal congestion symptoms.

Trial Locations

Locations (1)

Emory Aesthetic Center; 🇺🇸 Atlanta, Georgia, United States