Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-04-23 @ 11:16 PM
Study NCT ID:
NCT02654834
Status:
WITHDRAWN
Last Update Posted:
2018-01-25
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxidative Stress in OR Personnel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Two 5 mL blood samples collected at the start of a work week and at the end of a work week.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2016-01-11', 'studyFirstSubmitQcDate': '2016-01-11', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxidative Stress', 'timeFrame': 'During exposure to volatile anesthetics over the course of a week in the work-place', 'description': 'The extent of oxidative stress (DNA damage and the generation of the biochemical markers) in operating room staff with different levels of exposure to halogenated hydrocarbons, in comparison to unexposed controls.'}], 'secondaryOutcomes': [{'measure': 'Psychological Stress', 'timeFrame': 'During exposure to volatile anesthetics over the course of a week in the work-place', 'description': 'To determine the relationship between oxidative stress and psychological stress, as assessed by validated psychometric measures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is investigate to the effect(s) of chronic occupational exposure to N20 and volatile anesthetics on the extent of oxidative stress (DNA damage and the generation of the biochemical markers) in operating room staff, with different levels of exposure to halogenated hydrocarbons, in comparison to unexposed controls (Intensive Care Staff), and to determine the relationship between the degree of oxidative stress and psychological stress, as assessed by validated psychometric measures.', 'detailedDescription': 'This is a single blinded randomized, controlled and prospective clinical trial comparing oxidative stress status in two groups.\n\nSubjects in two groups will be matched for gender, age, smoking habit and employment duration and will be randomized into one of the two groups of:\n\n1. Pediatric OR Staff, and\n2. control (e.g; ICU staff)\n\nBiomarkers of oxidative stress will be measured in two different time points in each subject, (Monday Morning and, Friday afternoon of that same week-\\>40 hours in Operating room or Intensive Care Unit).\n\nThe relationship between oxidative stress and psychological stress will also be assessed by validated psychometric measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Twenty operating room staff and twenty intensive care unit staff (40 Total Participants)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. CHOR-Staff who work \\> 40 hours per week in the operating rooms (Anesthesiologists, CRNA, Surgeons, Nurses)\n2. NOR- Intensive Care Unit Staff who work \\> 40 hours per week in Intensive care unit (Physicians, Nurses, APN'S)\n\nExclusion Criteria:\n\nStaff with the following history will be excluded:\n\n1. Therapeutic exposure to radiation\n2. On chemotherapeutic agents\n3. History of General Anesthesia during the past two years"}, 'identificationModule': {'nctId': 'NCT02654834', 'briefTitle': 'Oxidative Stress in OR Personnel', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'Oxidative Stress Status During Anesthesia in Pediatric Surgical Room Staff Versus Non-operating Room Personnel: Pilot Study', 'orgStudyIdInfo': {'id': 'IRB14-00098'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric Operating Room (OR) Staff', 'description': 'OR Staff exposed to nitrous oxide, and other volatile anesthetics', 'interventionNames': ['Other: Exposure to nitrous oxide or other volatile anesthetics']}, {'label': 'Pediatric Intensive Care Unit (ICU) Staff', 'description': 'ICU Staff unexposed to any volatile anesthetics'}], 'interventions': [{'name': 'Exposure to nitrous oxide or other volatile anesthetics', 'type': 'OTHER', 'description': 'No intervention, but routine work-place exposure to volatile anesthetics', 'armGroupLabels': ['Pediatric Operating Room (OR) Staff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Nationwide Children's Hospital", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Haleh Saadat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nationwide Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Complementary and Alternative Medicine', 'investigatorFullName': 'Haleh Saadat', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}