Clinical trial NCT02342405: High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers
Official title: Effect of High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers: a Randomized Controlled Cross-over Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Keywords: Oxidative stress
Nitrogen oxide
Reactive oxygen species
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers between 18 and 30 years who has given an oral and written informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Endothelial dysfunction assessed by the EndoPat-system
timeFrame: After 2 hours of preoxygenation
Secondary outcomes:
measure: Heart rate variability (HRV) after ischemia-reperfusion as a measure of altered balance in the Autonomic nervous system
timeFrame: Baseline measure conducted from baseline until 20 minutes of pre oxygenation. Secondary measures is conducted 20 minutes before withdrawal of the oxygen
measure: Plasma-Malondialdehyde (MDA)
timeFrame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
measure: Plasma-Arginine/Asymmetric dimethylarginine(ADMA)
timeFrame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
measure: Plasma-Tetrahydrobiopterin
timeFrame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
measure: Plasma-Advanced oxidation protein products (AOPP)
timeFrame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
measure: Plasma-Ascorbate/Dehydroascorbate (AA/DHA)
timeFrame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Other outcomes:
Locations:
city: Koge
country: Denmark
facility: UHKoge
Study officials:
affiliation: Department of surgery, Køge University Hospital
name: Ismail Gögenur, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larsen MHH, Ekeloef S, Kokotovic D, Schou-Pedersen AM, Lykkesfeldt J, Gogenur I. Effect of High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers: A Randomized Controlled Crossover Pilot Study. Anesth Analg. 2017 Nov;125(5):1793-1796. doi: 10.1213/ANE.0000000000002357.