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临床试验/NCT02577692
NCT02577692Unknown不适用

Impact of Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers: A Randomized Controlled Cross-over Trial

Klinikum der Universitaet Muenchen, Grosshadern1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Change in exhaled breath oxidative stress biomarker

研究概览

简要总结

High inspiratory oxygen fractions are known to induce oxidative stress and lipid peroxidation. The degrading products of oxidative stress induced lipid peroxidation are in part volatile and appear in breath where they can be measured non-invasively. However, there is lack of knowledge on the correlation of blood and breath biomarkers of oxidative stress.

This study aims to investigate the effects of a high inspiratory oxygen fraction on oxidative stress in healthy volunteers. The primary outcome is the appearance of exhaled breath biomarkers of oxidative stress by electrochemical sensors and ion mobility mass spectrometry. Secondary outcomes are changes in oxidative stress biomarkers in blood and their relationship to breath biomarkers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy male volunteers who have given an oral and written informed consent

排除标准

  • smoker or ex-smoker
  • any pulmonary disease
  • any heart disease
  • any chemotherapy in the past
  • any kind of daily medication

研究组 & 干预措施

Oxygen

Experimental

Day 1: breathing of 100% oxygen; Day 2: ambient air breathing

干预措施: Ambient (Other)

Ambient

Experimental

Day 1: breathing of 100% oxygen; Day 2: ambient air breathing

干预措施: Ambient (Other)

Oxygen

Experimental

Day 1: breathing of 100% oxygen; Day 2: ambient air breathing

干预措施: Oxygen (Other)

Ambient

Experimental

Day 1: breathing of 100% oxygen; Day 2: ambient air breathing

干预措施: Oxygen (Other)

结局指标

主要结局

Change in exhaled breath oxidative stress biomarker

时间窗: 1, 4, and 24 hour

Measurement of oxidative stress biomarkers in breath e.g. acetaldehyde, ethan, malondialdheyde, propionaldehyde, pentane

次要结局

  • Change in blood oxidative stress biomarkers(1, 4, and 24 hour)

研究者

发起方
Klinikum der Universitaet Muenchen, Grosshadern
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Dolch

Dr. med.

Klinikum der Universitaet Muenchen, Grosshadern

研究点 (1)

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