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临床试验/NCT04220853
NCT04220853已完成不适用

Changes in Nasal Airflow Parameters After Septoplasty and Turbinoplasty

University Hospital Ostrava2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Changes in airflow

研究概览

简要总结

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 .

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

盲法说明

No masking will be used in the study.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • patient incapable of general anesthesia

结局指标

主要结局

Changes in airflow

时间窗: 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 resistance

时间窗: 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 the cross-sectional area of the nasal passage

时间窗: 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.

次要结局

未报告次要终点

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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