Clinical trial NCT04220853: Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty
Official title: Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Nasal Septum; Deviation
Nasal Mucosa Hypertrophy
Keywords: nasal obstruction
septoplasty
turbinoplasty
nasal mucosa
nasal septum
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be divided into three parallel groups, depending on the indicated surgery - septoplasty, turbinoplasty, and septoplasty plus turbinoplasty.
Primary purpose: DIAGNOSTIC

Brief summary: 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 .

Detailed description: 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 at pre-defined intervals in patients after septoplasty and turbinoplasty .

Eligibility criteria: 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

Primary outcomes:
measure: Changes in resistance
timeFrame: 6 and 12 weeks after surgery
measure: Changes in airflow
timeFrame: 6 and 12 weeks after surgery
measure: Changes in the cross-sectional area of the nasal passage
timeFrame: 6 and 12 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Marek Plášek, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.