Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers
Impact of Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers: A Randomized Controlled Cross-over Trial
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 16, 2015
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedMarch 8, 2018
March 1, 2018
3.5 years
October 13, 2015
March 6, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in exhaled breath oxidative stress biomarker
Measurement of oxidative stress biomarkers in breath e.g. acetaldehyde, ethan, malondialdheyde, propionaldehyde, pentane
1, 4, and 24 hour
Secondary Outcomes (1)
Change in blood oxidative stress biomarkers
1, 4, and 24 hour
Study Arms (2)
Oxygen
EXPERIMENTALDay 1: breathing of 100% oxygen; Day 2: ambient air breathing
Ambient
EXPERIMENTALDay 1: breathing of 100% oxygen; Day 2: ambient air breathing
Interventions
Eligibility Criteria
You may qualify if:
- healthy male volunteers who have given an oral and written informed consent
You may not qualify if:
- smoker or ex-smoker
- any pulmonary disease
- any heart disease
- any chemotherapy in the past
- any kind of daily medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Klinikum der Universitaet Muenchen, Grosshadernlead
- Airbus Defence and Spacecollaborator
- DLR German Aerospace Centercollaborator
Study Sites (1)
Department of Aneshtesiology, University Hospital of Munich
München, Germany
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael E Dolch, MD
Klinikum der Universitaet Muenchen - Campus Grosshadern
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med.
Study Record Dates
First Submitted
October 13, 2015
First Posted
October 16, 2015
Study Start
May 1, 2016
Primary Completion
November 1, 2019
Study Completion
November 1, 2019
Last Updated
March 8, 2018
Record last verified: 2018-03