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

NCT05921396 | Unknown

• 1 other identifier: FNO/2023/RMM-NPIF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pituitary Adenoma Invasive; Nasal Obstruction

Keywords

Pituitary Adenoma; Nasal surgery; Rhinomanometry; Nasal inspiratory peak flow; Endoscopic nasal surgery

Outcome Measures

Primary Outcomes (1)

• Comparison of nasal patency measurement using rhinomanometry and NPIF

  Comparison of nasal patency measurement using rhinomanometry and Nasal Peak Inspiratory Flow (NPIF) will be performed at the preoperative examination, 1 month and 3 months after surgery. The volume will be measured in L/min. Rhinomanometry is a standard diagnostic tool aiming to objectively evaluate the respiratory function of the nose. It measures pressure and flow during normal inspiration and expiration through the nose. Nasal peak inspiratory flow (NPIF) measures the maximum airflow a patient is able to produce during forced nasal inspiration and is a measure of nasal patency.

  3 months

Secondary Outcomes (5)

• Olfactory examination

  3 months

• Lund-Kennedy scoring system

  3 months

• SNOT 22 questionnaire

  3 months

• RhinoVAS questionnaire

  3 months

• Nose Score

  3 months

Study Arms (1)

Nasal patency before and after pituitary adenoma surgery

EXPERIMENTAL

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

Procedure: Nasal patency - rhinomanometry; Procedure: Nasal patency - nasal inspiratory peak flow

Interventions

Nasal patency - rhinomanometry PROCEDURE

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

Nasal patency before and after pituitary adenoma surgery

Nasal patency - nasal inspiratory peak flow PROCEDURE

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

Nasal patency before and after pituitary adenoma surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age over 18 years
• patients with pituitary adenoma indicated to endoscopic transnasal extirpation of the pituitary adenoma

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead
• University of Ostrava: collaborator

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

RECRUITING

Related Publications (7)

• Messerer M, Cossu G, George M, Daniel RT. Endoscopic Endonasal Trans-sphenoidal Approach: Minimally Invasive Surgery for Pituitary Adenomas. J Vis Exp. 2018 Jan 17;(131):55896. doi: 10.3791/55896.

  PMID: 29364265 BACKGROUND

• Regmi D, Thapa A, Kc B, Shakya B. Endoscopic Endonasal Transsphenoidal Approach to Pituitary Adenoma: A Multi-disciplinary Approach. J Nepal Health Res Counc. 2017 Sep 8;15(2):174-177. doi: 10.3126/jnhrc.v15i2.18209.

  PMID: 29016590 BACKGROUND

• Rochet M, El-Hage W, Richa S, Kazour F, Atanasova B. Depression, Olfaction, and Quality of Life: A Mutual Relationship. Brain Sci. 2018 May 4;8(5):80. doi: 10.3390/brainsci8050080.

  PMID: 29734670 BACKGROUND

• Croy I, Nordin S, Hummel T. Olfactory disorders and quality of life--an updated review. Chem Senses. 2014 Mar;39(3):185-94. doi: 10.1093/chemse/bjt072. Epub 2014 Jan 15.

  PMID: 24429163 BACKGROUND

• Schreiber A, Bertazzoni G, Ferrari M, Rampinelli V, Verri P, Mattavelli D, Fontanella M, Nicolai P, Doglietto F. Nasal Morbidity and Quality of Life After Endoscopic Transsphenoidal Surgery: A Single-Center Prospective Study. World Neurosurg. 2019 Mar;123:e557-e565. doi: 10.1016/j.wneu.2018.11.212. Epub 2018 Dec 5.

  PMID: 30528530 BACKGROUND

• Rotenberg B, Tam S, Ryu WH, Duggal N. Microscopic versus endoscopic pituitary surgery: a systematic review. Laryngoscope. 2010 Jul;120(7):1292-7. doi: 10.1002/lary.20949.

  PMID: 20578228 BACKGROUND

• Soyka MB, Serra C, Regli L, Meier E, Holzmann D. Long-term olfactory outcome after nasoseptal flap reconstructions in midline skull base surgery. Am J Rhinol Allergy. 2017 Sep 1;31(5):334-337. doi: 10.2500/ajra.2017.31.4463.

  PMID: 28859712 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction; Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Jakub Lubojacký, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

+42059737; jiri.hyncica@fno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study subjects will be enrolled into one study group.

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: July 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)