Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

December 6, 2022 updated by: University Hospital Ostrava

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 70852
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Septoplasty
The patients indicated for septoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.
Diagnostic test: 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.
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.
Experimental: Turbinoplasty
The patients indicated for turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery.
Diagnostic test: 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.
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.
Experimental: 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.
Diagnostic test: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in resistance
Time Frame: 6 and 12 weeks after surgery
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
Changes in airflow
Time Frame: 6 and 12 weeks after surgery
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
Changes in the cross-sectional area of the nasal passage
Time Frame: 6 and 12 weeks after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Marek Plášek, MD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

January 5, 2020

First Posted (Actual)

January 7, 2020

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-ENT-Nasal_obstruction

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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