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Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

Primary Purpose

Nasal Obstruction, Nasal Septum; Deviation, Nasal Mucosa Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Rhinomanometry in patients after septoplasty and/or turbinoplasty
Acoustic rhinometry in patients after septoplasty and/or turbinoplasty
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nasal Obstruction focused on measuring nasal obstruction, septoplasty, turbinoplasty, nasal mucosa, nasal septum

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Septoplasty

Turbinoplasty

Septoplasty and turbinoplasty

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
Changes in airflow
Changes in airflow (measured in ml/s - millilitres/second) will be assessed with rhinomanometry 6 and 12 weeks after surgery.
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.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2019
Last Updated
December 6, 2022
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT04220853
Brief Title
Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty
Official Title
Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction, Nasal Septum; Deviation, Nasal Mucosa Hypertrophy
Keywords
nasal obstruction, septoplasty, turbinoplasty, nasal mucosa, nasal septum

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be divided into three parallel groups, depending on the indicated surgery - septoplasty, turbinoplasty, and septoplasty plus turbinoplasty.
Masking
None (Open Label)
Masking Description
No masking will be used in the study.
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Septoplasty
Arm Type
Experimental
Arm Description
The patients indicated for septoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.
Arm Title
Turbinoplasty
Arm Type
Experimental
Arm Description
The patients indicated for turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.
Arm Title
Septoplasty and turbinoplasty
Arm Type
Experimental
Arm Description
The patients indicated for septoplasty and turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.
Intervention Type
Diagnostic Test
Intervention Name(s)
Rhinomanometry in patients after septoplasty and/or turbinoplasty
Intervention Description
Rhinomanometry is an examination used to assess changes in resistance and airflow in patients after septoplasty and/or turbinoplasty.
Intervention Type
Diagnostic Test
Intervention Name(s)
Acoustic rhinometry in patients after septoplasty and/or turbinoplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in resistance
Description
Changes in resistance (measured in Pa-s/ml - Pascal-second/millilitre) will be assessed with rhinomanometry 6 and 12 weeks after surgery.
Time Frame
6 and 12 weeks after surgery
Title
Changes in airflow
Description
Changes in airflow (measured in ml/s - millilitres/second) will be assessed with rhinomanometry 6 and 12 weeks after surgery.
Time Frame
6 and 12 weeks after surgery
Title
Changes in the cross-sectional area of the nasal passage
Description
Changes in the cross-sectional area of the nasal passage will be assessed with acoustic rhinometry 6 and 12 weeks after surgery.
Time Frame
6 and 12 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marek Plášek, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava
State/Province
Moravian-Silesian Region
ZIP/Postal Code
70852
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data available to other researchers.
Citations:
PubMed Identifier
28888024
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.
Results Reference
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PubMed Identifier
26447365
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.
Results Reference
background
PubMed Identifier
31267334
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.
Results Reference
background
PubMed Identifier
11826688
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.
Results Reference
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Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

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