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临床试验/NCT04418973
NCT04418973已完成不适用

Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject, by a Threshold Inspiratory Load and During a Maximal Breath Holding.

Hopital Foch2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2020年9月7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
Hopital Foch
入组人数
41
试验地点
2
主要终点
Comparison of variation of volatile organic compounds profiles in exhaled air during dyspnea and normal breathing.

研究概览

简要总结

The dyspnea is a common symptom in patients with many respiratory diseases particularly chronic obstructive airway diseases, but also cardiovascular pathologies, obesity, or also in the deconditioned healthy subjects.

Called volatolom corresponds to the set of volatile organic compounds (VOCs) contained in exhaled air.

The analysis of volatolom can be done either by the methods based on mass spectrometry which allows the identification of each VOC in the exhaled air or by the use of electronic noses which are more simple to use, less specific and produce a quantitive signal change based on pattern recognition algorithms providing a global profile of the VOC without identifying them.

The aim of the study is to determine whether the analysis of VOCs in exhaled air would identify biomarkers related to the intensity and type of experimental dyspnea.

研究设计

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

入排标准

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

入选标准

  • healthy subject
  • no dyspnea
  • non smoking or daily smoking more than 5 years packs
  • perfect knowing of the French language
  • the consent form signed
  • affiliated to a health insurance plan

排除标准

  • chronic disease
  • history of asthma or Chronic obstructive pulmonary disease (COPD)
  • personal or family atopy
  • cannabis use
  • electronic cigarette
  • medication except contraception
  • pregnant woman
  • without liberty or guardianship

结局指标

主要结局

Comparison of variation of volatile organic compounds profiles in exhaled air during dyspnea and normal breathing.

时间窗: at the only one study visit: around 2 hours

Comparison of variation in VOC profiles in exhaled air of healthy subjects, over 2 types of dyspnea (inspiratory load and breath holding) relative to VOC profiles during normal rest ventilation. The VOC will be identified by their molecular mass (by the mass spectrometry) and the variations in the sensors properties of the electronic noses producing a quantitive signal change based on pattern recognition algorithms.

次要结局

  • Correlation between the intensity of the sensory components of the dyspnea and the variation of VOC profiles.(at the only one study visit: around 2 hours)
  • Comparison of variation of volatile organic compounds profiles in exhaled air between the 2 types of dyspnea.(at the only one study visit: around 2 hours)
  • Correlation between the intensity of the affective component of the dyspnea and the variation of VOC profiles.(at the only one study visit: around 2 hours)
  • Comparison of VOC profiles in exhaled air according to smoking status.(at the only one study visit: around 2 hours)

研究者

发起方
Hopital Foch
申办方类型
Other
责任方
Sponsor

研究点 (2)

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