Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT04591756
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2020-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Respiratory Protection During Simulated Resuscitation: a Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2020-10-12', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Detection of Testing Agent', 'timeFrame': '2 minutes', 'description': 'Subject reported detection of testing agent'}], 'secondaryOutcomes': [{'measure': 'Time to detection of testing agent', 'timeFrame': '2 minutes', 'description': 'Time to subject reported detection of testing agent'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respirator', 'Cardiopulmonary resusitation'], 'conditions': ['Occupational Exposure']}, 'descriptionModule': {'briefSummary': 'The study hypothesizes that EHMRs with P100 filters will provide superior respiratory protection during simulated CPR compared to disposable N95 FFRs as measured by qualitative fit testing.\n\nTo this end, the study is a prospective observational cohort to evaluate the effectiveness of disposable FFRs and EHMR during simulated CPR. The primary endpoint will be subject report of detection of the testing agent during a 2 minute session of simulated chest compressions on a mannequin while wearing the respiratory protection that subjects routinely wear during the course of employment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current use of respirator within last 7 days\n* Completed fit test with respirator within last 2 years\n\nExclusion Criteria:\n\n* Previous adverse reaction to fit testing or testing agent\n* Development of any health problem that precludes use of a respirator since last occupational health evaluation'}, 'identificationModule': {'nctId': 'NCT04591756', 'briefTitle': 'Effectiveness of Respiratory Protection During Simulated Resuscitation: a Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Effectiveness of Respiratory Protection During Simulated Resuscitation: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'HSR200209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'N95 Filtering Facepiece Respirator', 'description': 'Subjects will wear the model of filtering facepiece respirator that they are currently approved to wear', 'interventionNames': ['Other: Qualitative Fit Testing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Elastomeric Half-Mask Respirator with P100 filters', 'description': 'Subjects will wear the model of elastomeric half mask respirator that they are currently approved to wear.', 'interventionNames': ['Other: Qualitative Fit Testing']}], 'interventions': [{'name': 'Qualitative Fit Testing', 'type': 'OTHER', 'description': 'Qualitative fit testing with denatonium benzoate', 'armGroupLabels': ['Elastomeric Half-Mask Respirator with P100 filters', 'N95 Filtering Facepiece Respirator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'UVAHealth', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Andrew Barros, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Medicine, Pulmonary and Critical Care', 'investigatorFullName': 'Andrew Barros', 'investigatorAffiliation': 'University of Virginia'}}}}