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临床试验/NCT05921396
NCT05921396招募中不适用

Assessment of Nasal Obstruction, a Comparison Between Rhinomanometry and Nasal Inspiratory Peak Flow at Patients After Endoscopic Nasal Surgery

University Hospital Ostrava2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
2
主要终点
Comparison of nasal patency measurement using rhinomanometry and NPIF

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Comparison of nasal patency measurement using rhinomanometry and NPIF

时间窗: 3 months

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.

次要结局

  • Olfactory examination(3 months)
  • RhinoVAS questionnaire(3 months)
  • Nose Score(3 months)
  • Lund-Kennedy scoring system(3 months)
  • SNOT 22 questionnaire(3 months)

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (2)

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