Nasal Obstruction Clinical Trial
Official title:
Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty
Verified date | December 2022 |
Source | University Hospital Ostrava |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pathological-anatomical changes in the nasal cavity (nasal septum/perforation, mucosal hypertrophy) negatively affect nasal airflow, increase resistance - cause nasal obstruction and are often an indication for surgery. The aim of the study is to examine nasal airflow parameters after septoplasty and turbinoplasty .
Status | Completed |
Enrollment | 30 |
Est. completion date | October 31, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - patients with nasal obstruction (nasal septal deviation, hypertrophy of nasal mucosa) - 18 to 70 Years - patient capable of general anesthesia - signing of the informed consent Exclusion Criteria: - patient incapable of general anesthesia |
Country | Name | City | State |
---|---|---|---|
Czechia | University Hospital Ostrava | Ostrava | Moravian-Silesian Region |
Lead Sponsor | Collaborator |
---|---|
University Hospital Ostrava |
Czechia,
Borojeni AAT, Garcia GJM, Moghaddam MG, Frank-Ito DO, Kimbell JS, Laud PW, Koenig LJ, Rhee JS. Normative ranges of nasal airflow variables in healthy adults. Int J Comput Assist Radiol Surg. 2020 Jan;15(1):87-98. doi: 10.1007/s11548-019-02023-y. Epub 2019 Jul 2. — View Citation
Mlynski G, Grutzenmacher S, Plontke S, Mlynski B, Lang C. Correlation of nasal morphology and respiratory function. Rhinology. 2001 Dec;39(4):197-201. — View Citation
Ottaviano G, Fokkens WJ. Measurements of nasal airflow and patency: a critical review with emphasis on the use of peak nasal inspiratory flow in daily practice. Allergy. 2016 Feb;71(2):162-74. doi: 10.1111/all.12778. — View Citation
Parthasarathi K, Christensen JM, Alvarado R, Barham HP, Sacks R, Harvey RJ. Airflow and symptom outcomes between allergic and non-allergic rhinitis patients from turbinoplasty. Rhinology. 2017 Dec 1;55(4):332-338. doi: 10.4193/Rhin16.210. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in resistance | Changes in resistance (measured in Pa-s/ml - Pascal-second/millilitre) will be assessed with rhinomanometry 6 and 12 weeks after surgery. | 6 and 12 weeks after surgery | |
Primary | Changes in airflow | Changes in airflow (measured in ml/s - millilitres/second) will be assessed with rhinomanometry 6 and 12 weeks after surgery. | 6 and 12 weeks after surgery | |
Primary | Changes in the cross-sectional area of the nasal passage | Changes in the cross-sectional area of the nasal passage will be assessed with acoustic rhinometry 6 and 12 weeks after surgery. | 6 and 12 weeks after surgery |
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