Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT02577692
Status:
UNKNOWN
Last Update Posted:
2018-03-08
First Post:
2015-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010100', 'term': 'Oxygen'}, {'id': 'D052638', 'term': 'Particulate Matter'}], 'ancestors': [{'id': 'D018011', 'term': 'Chalcogens'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-06', 'studyFirstSubmitDate': '2015-10-13', 'studyFirstSubmitQcDate': '2015-10-15', 'lastUpdatePostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in exhaled breath oxidative stress biomarker', 'timeFrame': '1, 4, and 24 hour', 'description': 'Measurement of oxidative stress biomarkers in breath e.g. acetaldehyde, ethan, malondialdheyde, propionaldehyde, pentane'}], 'secondaryOutcomes': [{'measure': 'Change in blood oxidative stress biomarkers', 'timeFrame': '1, 4, and 24 hour', 'description': 'Measurement of oxidative stress biomarkers in blood e.g. ethane, malondialdehyde, pentane, propionaldheyde, total oxidative and antioxidative capacity, glutathione'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Oxidative Stress']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male volunteers who have given an oral and written informed consent\n\nExclusion Criteria:\n\n* smoker or ex-smoker\n* any pulmonary disease\n* any heart disease\n* any chemotherapy in the past\n* any kind of daily medication'}, 'identificationModule': {'nctId': 'NCT02577692', 'briefTitle': 'Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Klinikum der Universitaet Muenchen, Grosshadern'}, 'officialTitle': 'Impact of Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers: A Randomized Controlled Cross-over Trial', 'orgStudyIdInfo': {'id': 'eN-2015-1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxygen', 'description': 'Day 1: breathing of 100% oxygen; Day 2: ambient air breathing', 'interventionNames': ['Other: Oxygen', 'Other: Ambient']}, {'type': 'EXPERIMENTAL', 'label': 'Ambient', 'description': 'Day 1: breathing of 100% oxygen; Day 2: ambient air breathing', 'interventionNames': ['Other: Oxygen', 'Other: Ambient']}], 'interventions': [{'name': 'Oxygen', 'type': 'OTHER', 'description': 'breathing oxygen', 'armGroupLabels': ['Ambient', 'Oxygen']}, {'name': 'Ambient', 'type': 'OTHER', 'description': 'breathing ambient air', 'armGroupLabels': ['Ambient', 'Oxygen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'München', 'country': 'Germany', 'facility': 'Department of Aneshtesiology, University Hospital of Munich', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}], 'overallOfficials': [{'name': 'Michael E Dolch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinikum der Universitaet Muenchen - Campus Grosshadern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Klinikum der Universitaet Muenchen, Grosshadern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Airbus Defence and Space', 'class': 'INDUSTRY'}, {'name': 'DLR German Aerospace Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med.', 'investigatorFullName': 'Michael Dolch', 'investigatorAffiliation': 'Klinikum der Universitaet Muenchen, Grosshadern'}}}}