Clinical trial NCT02787421: Nasal Dilator Strips for Rhinoplasty
Official title: Predictive Value of Nasal Dilator Strips for Evaluating Nasal Valve Obstruction as Measured by Post-Operative Rhinoplasty Outcomes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nasal Valve Compromise
Keywords: Reconstructive Surgery
Rhinoplasty
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Change in Nasal Obstruction and Septoplasty Effectiveness (NOSE) Instrument Score
timeFrame: Prior to surgery and again at 6-10 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Aesthetic Center
state: Georgia
Study officials:
affiliation: Emory University
name: Anita Sethna, MD
role: PRINCIPAL_INVESTIGATOR
References: