Nasal Dilator Strips for Rhinoplasty

NCT ID: NCT02787421

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2017-05-31

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.

Conditions

Nasal Valve Compromise

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Functional Rhinoplasty

Participants undergoing functional rhinoplasty for nasal valve compromise and obstruction at the Emory Aesthetics Center.

Group Type: EXPERIMENTAL

Breathe-Rite Nasal Dilator Strip

Intervention Type: DEVICE

During the pre-operative clinic visit, participants will be given a Breathe-Rite Nasal Dilator Strip

Interventions

Breathe-Rite Nasal Dilator Strip

During the pre-operative clinic visit, participants will be given a Breathe-Rite Nasal Dilator Strip

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Anita Sethna

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anita Sethna, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Aesthetic Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00086968

Identifier Type: -

Identifier Source: org_study_id