Nasal Obstruction Compared by Rhinomanometry and Nasal Inspiratory Peak Flow After Endoscopic Nasal Surgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05921396
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital Ostrava
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jakub Lubojacký, MD
Principal Investigator Affiliation	University Hospital Ostrava
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Czechia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pituitary Adenoma Invasive, Nasal Obstruction

Additional Details

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.

Arms & Interventions

Arms

Experimental: Nasal patency before and after pituitary adenoma surgery

Nasal patency in patients with pituitary adenoma indicated to endoscopic transnasal extirpation of the pituitary adenoma.

Interventions

Procedure: - Nasal patency - rhinomanometry

Nasal patency before and after the pituitary adenoma surgery will be assessed using rhinomanometry.

Procedure: - Nasal patency - nasal inspiratory peak flow

Nasal patency before and after the pituitary adenoma surgery will be assessed using nasal inspiratory peak flow..

Contact a Trial Team

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International Sites

University Hospital Ostrava, Ostrava, Moravian-Silesian Region, Czechia

Status

Recruiting

Address

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852

Site Contact

Jiří Hynčica

[email protected]

0042059737 #2587

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