Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-01-04 @ 8:57 AM
Study NCT ID:
NCT04406220
Status:
COMPLETED
Last Update Posted:
2020-05-28
First Post:
2020-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Large Versus Small Clog Size on Emergency Response Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060051', 'term': 'Occupational Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-27', 'studyFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to complete the running course', 'timeFrame': 'Follow-up until 60 minutes.', 'description': 'The time to complete the course will be compared between the two groups using a linear model with the randomized allocation and the stratification variable as covariates.'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Follow-up until 60 minutes.'}, {'measure': 'Time to complete the running course for specific subgroups: By gender, job function, level of fitness.', 'timeFrame': 'Follow-up until 60 minutes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clothing', 'Occupational Injuries']}, 'referencesModule': {'references': [{'pmid': '32799180', 'type': 'DERIVED', 'citation': 'Elbers PWG, de Grooth HJ, Girbes ARJ. The effect of small versus large clog size on emergency response time: A randomized controlled trial. J Crit Care. 2020 Dec;60:116-119. doi: 10.1016/j.jcrc.2020.07.028. Epub 2020 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'In many hospitals, clogs, usually white, are provided for healthcare workers. In our hospital, health care professionals from the department of intensive care medicine may be summoned to an emergency situation on a 24/7 basis. Clogs are thought to be of importance for running. Although clogs are available in several sizes, clog size is typically left to the discretion of the individual healthcare worker. Interestingly,\n\nThe primary goal of this randomized controlled trial is to assess if wearing large size clogs as compared to small size clogs results in increased running speed.\n\nParticipants will be randomized to small versus large clog size using a using randomly permuted blocks stratified by gender. Following randomization, participants will wear the clogs of allocated size and complete a standardized running course.\n\nThe primary endpoint is the time taken to complete the course.\n\nThe enrolment of 50 subjects would provide 80% power to show a 5-second difference in the response time at an average response time of 30 seconds with a 6 second standard deviation.\n\nThe ethical committee judged the study protocol exempt from extensive review.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthcare workers aged 18 years or older.\n\nExclusion Criteria:\n\n* Inability to run on clogs.'}, 'identificationModule': {'nctId': 'NCT04406220', 'briefTitle': 'The Effect of Large Versus Small Clog Size on Emergency Response Time', 'organization': {'class': 'OTHER', 'fullName': 'Amsterdam UMC, location VUmc'}, 'officialTitle': 'The Effect of Large Versus Small Clog Size on Healthcare Professional Emergency Response Time: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2019-clog'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Small clog size', 'interventionNames': ['Other: Small clog size']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Large clog size', 'interventionNames': ['Other: Large clog size']}], 'interventions': [{'name': 'Small clog size', 'type': 'OTHER', 'description': 'Participants will be randomized to run in small clogs', 'armGroupLabels': ['Small clog size']}, {'name': 'Large clog size', 'type': 'OTHER', 'description': 'Participants will be randomized to run in large clogs', 'armGroupLabels': ['Large clog size']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam UMC, location VUmc', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Paul Elbers, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Amsterdam UMC, location VUmc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amsterdam UMC, location VUmc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinating investigator', 'investigatorFullName': 'H.J.S. de Grooth, MD', 'investigatorAffiliation': 'Amsterdam UMC, location VUmc'}}}}