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High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers

Primary Purpose

Endothelial Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
80% oxygen
30% oxygen
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endothelial Dysfunction focused on measuring Oxidative stress, Nitrogen oxide, Reactive oxygen species

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • UHKoge

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

30% oxygen

80% oxygen

Arm Description

Inhalation of 30% oxygen

Inhalation of 80% oxygen

Outcomes

Primary Outcome Measures

Endothelial dysfunction assessed by the EndoPat-system
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

Heart rate variability (HRV) after ischemia-reperfusion as a measure of altered balance in the Autonomic nervous system
Plasma-Malondialdehyde (MDA)
Plasma-Arginine/Asymmetric dimethylarginine(ADMA)
Plasma-Tetrahydrobiopterin
Plasma-Advanced oxidation protein products (AOPP)
Plasma-Ascorbate/Dehydroascorbate (AA/DHA)

Full Information

First Posted
January 14, 2015
Last Updated
May 26, 2015
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02342405
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zealand University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction
Keywords
Oxidative stress, Nitrogen oxide, Reactive oxygen species

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
30% oxygen
Arm Type
Placebo Comparator
Arm Description
Inhalation of 30% oxygen
Arm Title
80% oxygen
Arm Type
Experimental
Arm Description
Inhalation of 80% oxygen
Intervention Type
Other
Intervention Name(s)
80% oxygen
Intervention Type
Other
Intervention Name(s)
30% oxygen
Primary Outcome Measure Information:
Title
Endothelial dysfunction assessed by the EndoPat-system
Description
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
Time Frame
After 2 hours of preoxygenation
Secondary Outcome Measure Information:
Title
Heart rate variability (HRV) after ischemia-reperfusion as a measure of altered balance in the Autonomic nervous system
Time Frame
Baseline measure conducted from baseline until 20 minutes of pre oxygenation. Secondary measures is conducted 20 minutes before withdrawal of the oxygen
Title
Plasma-Malondialdehyde (MDA)
Time Frame
Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Title
Plasma-Arginine/Asymmetric dimethylarginine(ADMA)
Time Frame
Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Title
Plasma-Tetrahydrobiopterin
Time Frame
Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Title
Plasma-Advanced oxidation protein products (AOPP)
Time Frame
Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure
Title
Plasma-Ascorbate/Dehydroascorbate (AA/DHA)
Time Frame
Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismail Gögenur, MD, DMSc
Organizational Affiliation
Department of surgery, Køge University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHKoge
City
Koge
ZIP/Postal Code
4600
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28922226
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.
Results Reference
derived

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High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers

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