Clinical Trials Logo
  1. Home
  2. Nasal Obstruction
  3. NCT04220853
  4. Details
NCT04220853 Clinical Trial

Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

Nasal Obstruction Clinical Trial

Official title:
Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04220853
Other study ID # FNO-ENT-Nasal_obstruction
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date October 31, 2022

Study information
Verified date December 2022
Source University Hospital Ostrava
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 31, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.
• 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.

Locations
Country Name City State
Czechia University Hospital Ostrava Ostrava Moravian-Silesian Region

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT05582070 - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction N/A
Recruiting NCT04228016 - Efficacy of an Intranasal Stent on Nasal Obstruction at Night N/A
Completed NCT02914236 - Treatment of Nasal Airway Obstruction Using the Aerin Medical Device N/A
Completed NCT02952313 - Spirox Latera™ Implant Support of Lateral Nasal Wall Cartilage (LATERAL-OR) Study N/A
Completed NCT01965457 - Assessment of Adenoidal Obstruction in Children : Clinical Signs Versus Flexible Nasal Endoscopy and Roentgenographic Findings N/A
Completed NCT00850876 - Heated Humidified Continuous Positive Airway Pressure and Nasal Physiology N/A
Completed NCT03156270 - Treatment Outcome Using Vivaer Stylus to Treat Nasal Airway Obstruction N/A
Active, not recruiting NCT05099263 - The Vivaer Procedure for Treatment of the Septal Swell Bodies (SWELL) N/A
Recruiting NCT05573919 - VivAer: A Correlation Between Symptom Scores and Objective Findings N/A
Completed NCT03290300 - Quality of Life Impact of Nasal Airway Treatment With Aerin Medical Device
Recruiting NCT04499469 - The Role of Spreader Grafts in Reduction Rhinoseptoplasty: a Randomized Clinical Trial With Quality of Life Assessment N/A
Not yet recruiting NCT01702103 - Demonstrate the Therapeutic Clinical Equivalence of Two Mometasone Nasal Sprays Phase 3
Completed NCT03456115 - A New Treatment for Mechanical Nasal Obstruction N/A
Completed NCT00793117 - The Effect of Packing in Post Operative Management of FESS Phase 4
Completed NCT02964312 - LATERA-OFFICE Study N/A
Recruiting NCT04150783 - Computational Modeling of Cleft Lip Nasal Deformity and Assessment of Nasal Function and Treatment Outcomes
Completed NCT01506583 - Clinical Evaluation of QFlu Combo Test
Recruiting NCT03925389 - Outcome Analysis in Septorhinoplasty
Recruiting NCT05494346 - Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction N/A
Completed NCT01850511 - The Effect of Nasal Hair on Nasal Obstruction N/A