跳至主要内容
临床试验/NCT03197701
NCT03197701Unknown不适用

Maximal Effort-dependent Respiratory Flow Rates: Reproducibility and Reference Values

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Normal values for maximal inspiratory flow rates

研究概览

简要总结

The general objective of this project is to determine the best method to measure maximal inspiratory flow rates, to study their reproducibility and create reference equations in healthy subjects.

详细描述

  1. Reproducibility and reference values in normal subjects: the investigators will propose a method for measurement of the maximal inspiratory flow rates (MIFR) and establish their reproducibility in normal subjects. The variability of these inspiratory flow rates will be compared with the variability of effort dependent and non-effort dependent expiratory flow rates.

Also, reference equations will be drawn up and compared to the only existing set of reference values (2) (needing a revision). 2. Reproducibility in disease: the investigators will evaluate the reproducibility of the MIFR in patients with neuromuscular diseases (Steinert muscular dystrophy, amyotrophic lateral sclerosis) and with upper airway obstruction (tracheal stenosis, thyroid enlargement) and compare to the reproducibility of expiratory flow rates in this population. 3. Monitoring of diseases: In the neuromuscular patients MIFR will be correlated to the existing parameters used for monitoring of these diseases (respiratory muscle strength, forced vital capacity), with a longitudinal follow-up.

In the patients with upper airway obstruction the MIFR (quantitative measurement) will be compared to the visual inspection (qualitative interpretation) of the maximal flow-volume loop and also the evolution after a therapeutic intervention (airway stenting, thyroidectomy) will be monitored.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • healthy hospital workers or visitors

排除标准

  • current smokers or ex-smokers with a history of > 80 PY
  • Presence or history of serious illness or thorax deformity (questionnaire)
  • recent respiratory tract infection (1 week)

结局指标

主要结局

Normal values for maximal inspiratory flow rates

时间窗: 3 years

Maximal flow rate when 50% of inspiratory vital capacity has been inhaled (FIF50)

次要结局

  • Reproducibility of maximal inspiratory flow rates(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Maximal Effort-dependent Respiratory Flow Rates | 临床试验