Nasal ObstructionNCT04220853
Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty
A study testing Rhinomanometry in patients after septoplasty and/or turbinoplasty and Acoustic rhinometry in patients after septoplasty and/or turbinoplasty in people with Nasal Obstruction and Nasal Septum; Deviation, run by University Hospital Ostrava at 1 site in Czechia.
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 . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasal Obstruction, Nasal Septum; Deviation, Nasal Mucosa Hypertrophy
- What is being tested?
- Rhinomanometry in patients after septoplasty and/or turbinoplasty and Acoustic rhinometry in patients after septoplasty and/or turbinoplasty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2019to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patient incapable of general anesthesia
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
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 after septoplasty and turbinoplasty .
Read the 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 .
- Being tested
- Rhinomanometry in patients after septoplasty and/or turbinoplasty, Acoustic rhinometry in patients after septoplasty and/or turbinoplasty
- Keywords
- nasal obstruction, septoplasty, turbinoplasty, nasal mucosa, nasal septum
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhinomanometry in patients after septoplasty and/or turbinoplastyDiagnostic 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 turbinoplastyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Septoplasty | Experimental | The patients indicated for septoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery. Receives: 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. Receives: 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. Receives: Diagnostic Test: Rhinomanometry in patients after septoplasty and/or turbinoplasty; Diagnostic Test: Acoustic rhinometry in patients after septoplasty and/or turbinoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 and 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start1 Oct 2019
- Primary completion30 Sep 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marek Plášek, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220853
- Sponsor's protocol ID
- FNO-ENT-Nasal_obstruction
- Status last verified
- Dec 2022
- First submitted
- 4 Sep 2019
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
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.
PubMed 28888024Ottaviano 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.
PubMed 26447365Borojeni 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.
PubMed 31267334Mlynski G, Grutzenmacher S, Plontke S, Mlynski B, Lang C. Correlation of nasal morphology and respiratory function. Rhinology. 2001 Dec;39(4):197-201.
PubMed 11826688
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty
- ClinicalTrials.gov ID
- NCT04220853
- Acronym / sponsor ID
- FNO-ENT-Nasal_obstruction
- Keywords
- nasal obstruction, septoplasty, turbinoplasty, nasal mucosa, nasal septum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The patients will be divided into three parallel groups, depending on the indicated surgery - septoplasty, turbinoplasty, and septoplasty plus turbinoplasty.
| Arm | Type | Receives |
|---|---|---|
| Septoplasty | Experimental | Diagnostic Test: Rhinomanometry in patients after septoplasty and/or turbinoplasty, Diagnostic Test: Acoustic rhinometry in patients after septoplasty and/or turbinoplastyThe patients indicated for septoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery. |
| Turbinoplasty | Experimental | Diagnostic Test: Rhinomanometry in patients after septoplasty and/or turbinoplasty, Diagnostic Test: Acoustic rhinometry in patients after septoplasty and/or turbinoplastyThe patients indicated for turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery. |
| Septoplasty and turbinoplasty | Experimental | Diagnostic Test: Rhinomanometry in patients after septoplasty and/or turbinoplasty, Diagnostic Test: Acoustic rhinometry in patients after septoplasty and/or turbinoplastyThe patients indicated for septoplasty and turbinoplasty will be included in this arm. The patients will undergo rhinomanometry and acoustic rhinometry after the surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- patient incapable of general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rhinomanometry in patients after septoplasty and/or turbinoplastyRhinomanometry is an examination used to assess changes in resistance and airflow in patients after septoplasty and/or turbinoplasty. | Diagnostic test | Septoplasty, Septoplasty and turbinoplasty, Turbinoplasty |
| Acoustic rhinometry in patients after septoplasty and/or turbinoplastyAcoustic rhinometry is an examination used to assess changes in the cross-sectional area of the nasal passage in patients after septoplasty and/or turbinoplasty. | Diagnostic test | Septoplasty, Septoplasty and turbinoplasty, Turbinoplasty |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- Background: PubMed 28888024Parthasarathi 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.
- Background: PubMed 26447365Ottaviano 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.
- Background: PubMed 31267334Borojeni 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.
- Background: PubMed 11826688Mlynski G, Grutzenmacher S, Plontke S, Mlynski B, Lang C. Correlation of nasal morphology and respiratory function. Rhinology. 2001 Dec;39(4):197-201.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek Plášek, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhinomanometry in patients after septoplasty and/or turbinoplasty and Acoustic rhinometry in patients after septoplasty and/or turbinoplasty in people with Nasal Obstruction and Nasal Septum; Deviation, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in resistance (time frame: 6 and 12 weeks after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04220853, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2022.