High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers

Not Applicable

Completed

• Conditions: Endothelial Dysfunction
• Interventions: Other: 30% oxygen; Other: 80% oxygen

• Registration Number: NCT02342405
• Lead Sponsor: Zealand University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-19
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
30% oxygen	30% oxygen	Inhalation of 30% oxygen
80% oxygen	80% oxygen	Inhalation of 80% oxygen

Primary Outcome Measures

Name	Time	Method
Endothelial dysfunction assessed by the EndoPat-system	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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UHKoge; 🇩🇰 Koge, Denmark