Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers

March 6, 2018 updated by: Michael Dolch, Klinikum der Universitaet Muenchen, Grosshadern

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenchen, Germany
        • Department of Aneshtesiology, University Hospital of Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxygen
Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
Other: Oxygen
breathing oxygen
Other: Ambient
breathing ambient air
Experimental: Ambient
Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
Other: Oxygen
breathing oxygen
Other: Ambient
breathing ambient air

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in exhaled breath oxidative stress biomarker
Time Frame: 1, 4, and 24 hour
Measurement of oxidative stress biomarkers in breath e.g. acetaldehyde, ethan, malondialdheyde, propionaldehyde, pentane
1, 4, and 24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in blood oxidative stress biomarkers
Time Frame: 1, 4, and 24 hour
Measurement of oxidative stress biomarkers in blood e.g. ethane, malondialdehyde, pentane, propionaldheyde, total oxidative and antioxidative capacity, glutathione
1, 4, and 24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum der Universitaet Muenchen, Grosshadern

Collaborators

DLR German Aerospace Center
Airbus Defence and Space

Investigators

  • Principal Investigator: Michael E Dolch, MD, Klinikum der Universitaet Muenchen - Campus Grosshadern

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (Estimate)

October 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 8, 2018

Last Update Submitted That Met QC Criteria

March 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eN-2015-1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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