Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

NCT ID: NCT04220853

Last Updated: 2022-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-10-31

Brief Summary

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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

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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 .

Conditions

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Nasal Obstruction Nasal Septum; Deviation Nasal Mucosa Hypertrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The patients will be divided into three parallel groups, depending on the indicated surgery - septoplasty, turbinoplasty, and septoplasty plus turbinoplasty.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

No masking will be used in the study.

Study Groups

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Septoplasty

The patients indicated for septoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.

Group Type EXPERIMENTAL

Rhinomanometry in patients after septoplasty and/or turbinoplasty

Intervention Type DIAGNOSTIC_TEST

Rhinomanometry is an examination used to assess changes in resistance and airflow in patients after septoplasty and/or turbinoplasty.

Acoustic rhinometry in patients after septoplasty and/or turbinoplasty

Intervention Type DIAGNOSTIC_TEST

Acoustic rhinometry is an examination used to assess changes in the cross-sectional area of the nasal passage in patients after septoplasty and/or turbinoplasty.

Turbinoplasty

The patients indicated for turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.

Group Type EXPERIMENTAL

Rhinomanometry in patients after septoplasty and/or turbinoplasty

Intervention Type DIAGNOSTIC_TEST

Rhinomanometry is an examination used to assess changes in resistance and airflow in patients after septoplasty and/or turbinoplasty.

Acoustic rhinometry in patients after septoplasty and/or turbinoplasty

Intervention Type DIAGNOSTIC_TEST

Acoustic rhinometry is an examination used to assess changes in the cross-sectional area of the nasal passage in patients after septoplasty and/or turbinoplasty.

Septoplasty and turbinoplasty

The patients indicated for septoplasty and turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.

Group Type EXPERIMENTAL

Rhinomanometry in patients after septoplasty and/or turbinoplasty

Intervention Type DIAGNOSTIC_TEST

Rhinomanometry is an examination used to assess changes in resistance and airflow in patients after septoplasty and/or turbinoplasty.

Acoustic rhinometry in patients after septoplasty and/or turbinoplasty

Intervention Type DIAGNOSTIC_TEST

Acoustic rhinometry is an examination used to assess changes in the cross-sectional area of the nasal passage in patients after septoplasty and/or turbinoplasty.

Interventions

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Rhinomanometry in patients after septoplasty and/or turbinoplasty

Rhinomanometry is an examination used to assess changes in resistance and airflow in patients after septoplasty and/or turbinoplasty.

Intervention Type DIAGNOSTIC_TEST

Acoustic rhinometry in patients after septoplasty and/or turbinoplasty

Acoustic rhinometry is an examination used to assess changes in the cross-sectional area of the nasal passage in patients after septoplasty and/or turbinoplasty.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Ostrava

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marek Plášek, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

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University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 28888024 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26447365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31267334 (View on PubMed)

Mlynski G, Grutzenmacher S, Plontke S, Mlynski B, Lang C. Correlation of nasal morphology and respiratory function. Rhinology. 2001 Dec;39(4):197-201.

Reference Type BACKGROUND
PMID: 11826688 (View on PubMed)

Other Identifiers

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FNO-ENT-Nasal_obstruction

Identifier Type: -

Identifier Source: org_study_id

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