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Trial Title:
Nasal Obstruction Compared by Rhinomanometry and Nasal Inspiratory Peak Flow After Endoscopic Nasal Surgery
NCT ID:
NCT05921396
Condition:
Pituitary Adenoma Invasive
Nasal Obstruction
Conditions: Official terms:
Adenoma
Pituitary Neoplasms
Respiratory Aspiration
Nasal Obstruction
Pituitary Diseases
Conditions: Keywords:
Pituitary Adenoma
Nasal surgery
Rhinomanometry
Nasal inspiratory peak flow
Endoscopic nasal surgery
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
The study subjects will be enrolled into one study group.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Nasal patency - rhinomanometry
Description:
Nasal patency before and after the pituitary adenoma surgery will be assessed using
rhinomanometry.
Arm group label:
Nasal patency before and after pituitary adenoma surgery
Intervention type:
Procedure
Intervention name:
Nasal patency - nasal inspiratory peak flow
Description:
Nasal patency before and after the pituitary adenoma surgery will be assessed using nasal
inspiratory peak flow..
Arm group label:
Nasal patency before and after pituitary adenoma surgery
Summary:
The aim of the project is to determine whether nasal inspiratory peak flow is sufficient
for preoperative and postoperative measurement of nasal patency compared to
rhinomanometry.
Detailed description:
The nasal cavity is used to heat, humidify and purify the air before entering other parts
of the respiratory system. Other functions of the nose include in particular olfactory,
immune, reflex, or sexual functions. Proper airflow through the nasal cavity is essential
for all nasal functions; anatomical or flow changes can significantly affect nasal
functions.
Endoscopic transnasal surgical approaches are modern, mini-invasive methods, enabling the
solution of pathologies in the area of the cranial base, through the nasal cavity. The
advantage of this technique is the absence of external incisions and scars and
significantly better cosmetic effect, these methods also offer very good clarity and
illumination of the operating field. The main disadvantage is the risk of affecting the
functions of the nose. To create a transnasal approach to the skull base, it is necessary
to perform lateralization of middle turbinates, resection of the anterior wall of the
sphenoidal sinus, and resection of the posterior part of the nasal septum. These
interventions are necessary for a good overview and manipulation in the operated area,
however, they can lead to postoperative changes in the physiological functions of the
nasal cavity, especially loss of smell, and taste, altered airflow through the nasal
cavity, mucociliary transport disorders, nasal obstruction, crusting or drying mucous
membrane. All these adverse changes significantly affect the patient's quality of life.
As a standard, rhinomanometry is used to measure nasal patency before and after surgery.
A modern new method is measuring the patency of the nasal cavity using an NPIF (nasal
peak inspiratory flow) device, which has significantly lower acquisition costs, is easy
to use, and, above all, fast. The disadvantage is that the examination is less detailed,
the result is the amount of air flowing in l/min through the nasal cavity.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- age over 18 years
- patients with pituitary adenoma indicated to endoscopic transnasal extirpation of
the pituitary adenoma
Exclusion Criteria:
- patients after surgery of the nasal cavity or base of the skull
- patients with nasal disease and paranasal sinuses
- patients with olfactory disorders before surgery
- patients with nasal septal deviation that requires septoplasty
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Ostrava
Address:
City:
Ostrava
Zip:
70852
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Jiří Hynčica
Phone:
0042059737
Phone ext:
2587
Email:
jiri.hyncica@fno.cz
Investigator:
Last name:
Petr Matoušek, MD,PhD,MBA
Email:
Sub-Investigator
Investigator:
Last name:
Jakub Lubojacký, MD
Email:
Principal Investigator
Investigator:
Last name:
Michaela Mladoňová, MD
Email:
Sub-Investigator
Investigator:
Last name:
Petr Kántor, MD
Email:
Sub-Investigator
Investigator:
Last name:
Viktorie Hránková, MD
Email:
Sub-Investigator
Investigator:
Last name:
Pavel Komínek, Prof.,MD,PhD, MBA
Email:
Sub-Investigator
Start date:
July 1, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
University Hospital Ostrava
Agency class:
Other
Collaborator:
Agency:
University of Ostrava
Agency class:
Other
Source:
University Hospital Ostrava
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05921396
