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

NCT ID: NCT02577692

Last Updated: 2018-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Oxygen

Day 1: breathing of 100% oxygen; Day 2: ambient air breathing

Group Type EXPERIMENTAL

Oxygen

Intervention Type OTHER

breathing oxygen

Ambient

Intervention Type OTHER

breathing ambient air

Ambient

Day 1: breathing of 100% oxygen; Day 2: ambient air breathing

Group Type EXPERIMENTAL

Oxygen

Intervention Type OTHER

breathing oxygen

Ambient

Intervention Type OTHER

breathing ambient air

Interventions

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Oxygen

breathing oxygen

Intervention Type OTHER

Ambient

breathing ambient air

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Airbus Defence and Space

INDUSTRY

Sponsor Role collaborator

DLR German Aerospace Center

OTHER

Sponsor Role collaborator

Klinikum der Universitaet Muenchen, Grosshadern

OTHER

Sponsor Role lead

Responsible Party

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Michael Dolch

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael E Dolch, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum der Universitaet Muenchen - Campus Grosshadern

Locations

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Department of Aneshtesiology, University Hospital of Munich

München, , Germany

Site Status

Countries

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Germany

Other Identifiers

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eN-2015-1.0

Identifier Type: -

Identifier Source: org_study_id

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