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NCT Number: NCT04220853

Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

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 .

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Key information

Conditions

Nasal Obstruction Airway Obstruction Nasal Mucosa Hypertrophy Nasal Septum; Deviation Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rhinomanometry in patients after septoplasty and/or turbinoplasty

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 7, 2020
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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