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Nasal Dilator Strips for Rhinoplasty

Predictive Value of Nasal Dilator Strips for Evaluating Nasal Valve Obstruction as Measured by Post-Operative Rhinoplasty Outcomes

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02787421
Enrollment
0
Registered
2016-06-01
Start date
2016-04-30
Completion date
2017-05-31
Last updated
2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Valve Compromise

Keywords

Reconstructive Surgery, Rhinoplasty

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.

Interventions

DEVICEBreathe-Rite Nasal Dilator Strip

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

Sponsors

Emory University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Nasal Obstruction and Septoplasty Effectiveness (NOSE) Instrument ScorePrior to surgery and again at 6-10 weeks after surgeryThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026