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Nasal Dilator Strips for Rhinoplasty

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ClinicalTrials.gov Identifier: NCT02787421
Recruitment Status : Withdrawn (Study withdrawn - changing study design.)
First Posted : June 1, 2016
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Anita Sethna, 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.


Condition or disease Intervention/treatment Phase
Nasal Valve Compromise Device: Breathe-Rite Nasal Dilator Strip Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictive Value of Nasal Dilator Strips for Evaluating Nasal Valve Obstruction as Measured by Post-Operative Rhinoplasty Outcomes
Study Start Date : April 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: Functional Rhinoplasty
Participants undergoing functional rhinoplasty for nasal valve compromise and obstruction at the Emory Aesthetics Center.
Device: Breathe-Rite Nasal Dilator Strip
During the pre-operative clinic visit, participants will be given a Breathe-Rite Nasal Dilator Strip




Primary Outcome Measures :
  1. Change in Nasal Obstruction and Septoplasty Effectiveness (NOSE) Instrument Score [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787421


Locations
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United States, Georgia
Emory Aesthetic Center
Atlanta, Georgia, United States, 30327
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Anita Sethna, MD Emory University
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Responsible Party: Anita Sethna, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT02787421    
Other Study ID Numbers: IRB00086968
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Keywords provided by Anita Sethna, Emory University:
Reconstructive Surgery
Rhinoplasty