Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

NCT04220853 | Completed

• 1 other identifier: FNO-ENT-Nasal_obstruction
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 .

Conditions

Nasal Obstruction; Nasal Septum; Deviation; Nasal Mucosa Hypertrophy

Keywords

nasal obstruction; septoplasty; turbinoplasty; nasal mucosa; nasal septum

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  6 and 12 weeks after surgery

Study Arms (3)

Septoplasty

EXPERIMENTAL

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; Diagnostic Test: Acoustic rhinometry in patients after septoplasty and/or turbinoplasty

Turbinoplasty

EXPERIMENTAL

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; Diagnostic Test: Acoustic rhinometry in patients after septoplasty and/or turbinoplasty

Septoplasty and turbinoplasty

EXPERIMENTAL

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; Diagnostic Test: Acoustic rhinometry in patients after septoplasty and/or turbinoplasty

Interventions

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.

Septoplasty; Septoplasty and turbinoplasty; 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.

Septoplasty; Septoplasty and turbinoplasty; Turbinoplasty

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with nasal obstruction (nasal septal deviation, hypertrophy of nasal mucosa)
• to 70 Years
• patient capable of general anesthesia
• signing of the informed consent

You may not qualify if:

• \- patient incapable of general anesthesia

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (4)

• 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.

  PMID: 28888024 BACKGROUND

• 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.

  PMID: 26447365 BACKGROUND

• 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.

  PMID: 31267334 BACKGROUND

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

  PMID: 11826688 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Rhinomanometry; Rhinometry, Acoustic

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Manometry; Investigative Techniques

Study Officials

• Marek Plášek, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be used in the study.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be divided into three parallel groups, depending on the indicated surgery - septoplasty, turbinoplasty, and septoplasty plus turbinoplasty.

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: January 7, 2020
• Study Start: October 1, 2019
• Primary Completion: September 30, 2022
• Study Completion: October 31, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)