Effect of High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers: a Randomized Controlled Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Endothelial dysfunction assessed by the EndoPat-system
研究概览
简要总结
The frequency of preoperative cardiac ischemia and the 30-days postoperative mortality is much higher than previously assumed, with approximately 10 % of patients undergoing non-cardiac surgery suffering from postoperative myocardial injury. A recent danish study furthermore showed that patients treated with a high inspiratory oxygen fraction during surgery had a higher 1 year mortality compared with patients treated with a low inspiratory fraction. This was especially significant among patients undergoing cancer surgery. A possible explanation, is that a high oxygen fraction results in oxidative stress and endothelial dysfunction.
With this randomized cross-over study we wish to investigate the effect of a high inspiratory oxygen fraction on the endothelial function among healthy male volunteers. The primary outcome is the endothelial function assessed by the EndoPat system. Secondary outcomes are changes in oxidative biomarkers. Heart rate variability (HRV) recordings will serve as a measure for the effect of oxygen on the autonomic nervous system.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers between 18 and 30 years who has given an oral and written informed consent
排除标准
- •Smoking, or ex-smoker Any kind of medication on a daily basis History of atopic dermatitis Known familiar hypercholesterolemia History of arteriosclerotic disease in the first and second-degree relatives Known or unknown arrhythmias, as measured by the baseline HRV-recording
研究组 & 干预措施
80% oxygen
Inhalation of 80% oxygen
干预措施: 80% oxygen (Other)
30% oxygen
Inhalation of 30% oxygen
干预措施: 30% oxygen (Other)
结局指标
主要结局
Endothelial dysfunction assessed by the EndoPat-system
时间窗: After 2 hours of preoxygenation
Changes in baseline pulse-wave-amplitude (PWA) after ischemia-reperfusion from the baseline PWA measurement until 5 minutes after ischemia as a measure of altered endothelial cell function caused by high inspiratory oxygen fractions
次要结局
- Heart rate variability (HRV) after ischemia-reperfusion as a measure of altered balance in the Autonomic nervous system(Baseline measure conducted from baseline until 20 minutes of pre oxygenation. Secondary measures is conducted 20 minutes before withdrawal of the oxygen)
- Plasma-Malondialdehyde (MDA)(Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure)
- Plasma-Arginine/Asymmetric dimethylarginine(ADMA)(Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure)
- Plasma-Tetrahydrobiopterin(Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure)
- Plasma-Advanced oxidation protein products (AOPP)(Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure)
- Plasma-Ascorbate/Dehydroascorbate (AA/DHA)(Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure)
研究者
Ismail Gögenur
Professor.
Zealand University Hospital