Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT04427267
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2020-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-06-10', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin thermometry', 'timeFrame': '6 hours', 'description': 'DS1923-F5 Thermochron iButtons'}, {'measure': 'Hygrometry under costume', 'timeFrame': '6 hours', 'description': 'DS1923-F5 Thermochron iButtons'}, {'measure': 'Heart rate', 'timeFrame': '6 hours', 'description': 'A Polar H10 heart rate monitor (Polar Electro, Finland) will carry all items during the entire research'}, {'measure': 'Air thermometry', 'timeFrame': '6 hours', 'description': 'Meteoscop - M'}, {'measure': 'Air hygrometry', 'timeFrame': '6 hours', 'description': 'Meteoscop - M'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thermophysiology', 'Personal protective equipment from biological hazards', 'Medical workers', 'COVID-19'], 'conditions': ['Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients']}, 'descriptionModule': {'briefSummary': 'This research will provide data on thermal condition of medical workers who use personal protective equipment from biological hazards. Aquired data will be used to define acceptable period of use for these protective costumes.\n\nThis research will recruit 6 volunteers. During 6 hours each subject will perform their work using protective costume. Heart rate, skin and air temperature under costume and hygrometric data will be registered. Also there will be questionnaires for volunteers for subjective assessment of thermal and moisture sensations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Health workers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy individuals (based on medical screening)\n\nExclusion Criteria:\n\n* endocrinological diseases and disorders\n* health deviations at the time of the study'}, 'identificationModule': {'nctId': 'NCT04427267', 'briefTitle': 'Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients', 'organization': {'class': 'OTHER', 'fullName': 'Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"'}, 'officialTitle': 'Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment for Biological Factors During Their Work With COVID-19 Patients', 'orgStudyIdInfo': {'id': 'PPE-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Health workers', 'interventionNames': ['Other: Personal protective equipment from biological hazard']}], 'interventions': [{'name': 'Personal protective equipment from biological hazard', 'type': 'OTHER', 'description': 'Includes: isolation clothing, mask, eyewear, overshoes', 'armGroupLabels': ['Health workers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '105275', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Budgetary Scientific Institution Izmerov Research Institute of Occupational Health', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Laboratory of Personal Protective Equipment and Industrial Exoskeletons Andrey Geregey', 'investigatorFullName': 'Andrey Mikhailovich Geregey', 'investigatorAffiliation': 'Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health"'}}}}