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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577692
Recruitment Status : Unknown
Verified March 2018 by Michael Dolch, Klinikum der Universitaet Muenchen, Grosshadern.
Recruitment status was:  Active, not recruiting
First Posted : October 16, 2015
Last Update Posted : March 8, 2018
Sponsor:
Collaborators:
Airbus Defence and Space
DLR German Aerospace Center
Information provided by (Responsible Party):
Michael Dolch, Klinikum der Universitaet Muenchen, Grosshadern

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Oxidative Stress Other: Oxygen Other: Ambient Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers: A Randomized Controlled Cross-over Trial
Study Start Date : May 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577692


Locations
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Germany
Department of Aneshtesiology, University Hospital of Munich
Muenchen, Germany
Sponsors and Collaborators
Klinikum der Universitaet Muenchen, Grosshadern
Airbus Defence and Space
DLR German Aerospace Center
Investigators
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Principal Investigator: Michael E Dolch, MD Klinikum der Universitaet Muenchen - Campus Grosshadern
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Responsible Party: Michael Dolch, Dr. med., Klinikum der Universitaet Muenchen, Grosshadern
ClinicalTrials.gov Identifier: NCT02577692    
Other Study ID Numbers: eN-2015-1.0
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes