Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-25 @ 5:43 PM
Study NCT ID:
NCT04063969
Status:
COMPLETED
Last Update Posted:
2021-12-08
First Post:
2019-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2019-08-14', 'studyFirstSubmitQcDate': '2019-08-19', 'lastUpdatePostDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-assessed radiation safety climate', 'timeFrame': 'Baseline measurement on study inclusion (Day 1)', 'description': 'Radiation safety climate using radiation safety climate tool'}, {'measure': 'Self-assessed radiation safety behavior', 'timeFrame': 'Baseline measurement on study inclusion (Day 1)', 'description': 'Radiation safety behavior using radiation safety behavior tool'}, {'measure': 'Self-assessed radiation safety knowledge and motivation', 'timeFrame': 'Baseline measurement on study inclusion (Day 1)', 'description': 'Radiation safety knowledge and motivation using rating tool'}], 'secondaryOutcomes': [{'measure': 'Procedural radiation doses - Dose area product', 'timeFrame': 'Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion', 'description': 'Procedural dose area product (DAP)'}, {'measure': 'Procedural radiation doses - cumulative air kerma', 'timeFrame': 'Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion', 'description': 'Procedural cumulative air kerma (CAK)'}, {'measure': 'Procedural radiation doses - fluoroscopy time', 'timeFrame': 'Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion', 'description': 'Procedural fluoroscopy time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radiation safety', 'Radiation safety climate', 'Radiation safety behavior', 'Quality improvement', 'Patient safety'], 'conditions': ['Healthy Volunteers', 'Aortic Aneurysm, Abdominal']}, 'referencesModule': {'references': [{'pmid': '10912498', 'type': 'BACKGROUND', 'citation': 'Griffin MA, Neal A. Perceptions of safety at work: a framework for linking safety climate to safety performance, knowledge, and motivation. J Occup Health Psychol. 2000 Jul;5(3):347-58. doi: 10.1037//1076-8998.5.3.347.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to measure the radiation safety climate in the hybrid angiography suite using self-assessment and to investigate the relationship of radiation safety climate with their self-reported safety behaviors.\n\nThe hypothesis is that a radiation safety climate does exist and can be measured using self-assessment. Additionally, it is expected that the radiation safety climate positively influences radiation safety behaviors.', 'detailedDescription': 'Radiation safety in the hybrid angiography suite is a primordial safety component which is relevant for endovascular team members and patients. To date, many interventions which aim to improve radiation safety habits of an endovascular team focus on improving technology and team radiation safety knowledge. Safety literature has indicated that a safety climate can be identified as the shared perceptions of team members or workers about the safety in their workspace and that this safety climate is closely related to safety behaviors and outcomes. In endovascular specialties, the concept of a radiation safety climate remains unexplored. Therefore, this study aims to measure the radiation safety climate in a diverse pool of endovascular team members from different hospitals, using self-assessment questionnaires and to investigate the relationship of radiation safety climate with their self-reported safety behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Endovascular team members: vascular surgeons, surgical trainees, operating nurses\n* Patients undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm', 'eligibilityCriteria': 'Endovascular team member group\n\nInclusion Criteria:\n\n* Vascular surgeon OR surgical trainee OR operating nurse\n* Active at one of the participating hospitals\n\nExclusion Criteria:\n\n* No exclusion criteria apply to this study.\n\nPatient group Inclusion Criteria\n\n* Patient undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm\n\nExclusion criteria\n\n* Emergency repair (ruptured aneurysm)\n* Additional interventional procedures (iliac aneurysm, treatment of peripheral vessel disease)'}, 'identificationModule': {'nctId': 'NCT04063969', 'briefTitle': 'Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite and Its Effects on Radiation Safety Performance', 'orgStudyIdInfo': {'id': 'B670201837824'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endovascular team members', 'description': 'All vascular surgeons, surgical trainees, nurses active in the hybrid angiography suite at one of the participating centers will be invited to participate in the study.\n\nAll participating team members complete an online questionnaire containing an assessment of their perceived radiation safety climate (28 items, 5 dimensions), radiation safety behaviors(2 items, 2 dimensions), radiation safety knowledge (single item) and radiation safety motivation (single item). All data will be stored pseudonymized.', 'interventionNames': ['Other: Assessment of radiation safety climate', 'Other: Assessment of radiation safety behavior', 'Other: Assessment of radiation safety knowledge and motivation']}, {'label': 'Vascular surgical patients', 'description': 'In each center, five patients undergoing primary elective endovascular repair for an infrarenal abdominal aortic aneurysm (EVAR) will be enrolled in the study.\n\nFor each participating patient, a set of demographical (BMI, case difficulty, ASA-grade,etc.), procedure-related (procedure duration, contrast use, etc.) and radiation dose parameters (DAP, cumulative air kerma) will be collected and stored in a pseudonymized way.\n\nParticipation in this study has no effect on the interventional procedure, or the chosen approach.', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Assessment of radiation safety climate', 'type': 'OTHER', 'otherNames': ['Radiation safety climate rating tool'], 'description': 'The rating tool contains 28 statements which cover 5 dimensions (Leadership, communication, commitment, resources, risk awareness) of the radiation safety climate. Participants are asked to indicate on a scale of 1 (completely disagree) - 3 (neutral) - 5 (completely agree) whether they agree with each statement. A composite radiation safety climate score is calculated by adding ratings on all items.\n\nMinimum scale score 28 - Maximum scale score 140', 'armGroupLabels': ['Endovascular team members']}, {'name': 'Assessment of radiation safety behavior', 'type': 'OTHER', 'otherNames': ['Radiation safety behavior rating tool'], 'description': 'The rating tool contains 2 statements which cover 2 dimensions of the radiation safety behavior. Participants are asked to indicate on a scale of 1 (completely disagree) - 3 (neutral) - 5 (completely agree) whether they agree with each statement. A composite radiation safety behavior score is calculated by adding ratings on both items Minimum scale score 2 - Maximum scale score 10', 'armGroupLabels': ['Endovascular team members']}, {'name': 'Assessment of radiation safety knowledge and motivation', 'type': 'OTHER', 'otherNames': ['Radiation safety knowledge and motivation rating tool'], 'description': 'The rating tool contains 2 statements which cover the radiation safety knowledge and behavior. Participants are asked to indicate on a scale of 1 (completely disagree) - 3 (neutral) - 5 (completely agree) whether they agree with each statement.\n\nMinimum item score 1 - maximum item score 5', 'armGroupLabels': ['Endovascular team members']}, {'name': 'Data collection', 'type': 'OTHER', 'description': 'Collection of patient-related data points Demographic information: ASA-classification, BMI Procedure related information: Procedural time, approach, contrast usage case difficulty Radiation safety parameters: Air Kerma, DAP, fluoroscopy time', 'armGroupLabels': ['Vascular surgical patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost Vlaanderen', 'country': 'Belgium', 'facility': 'Algemeen Ziekenhuis Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '9000', 'city': 'Ghent', 'state': 'Oost Vlaanderen', 'country': 'Belgium', 'facility': 'Ghent University Hospital', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '8000', 'city': 'Bruges', 'state': 'West Vlaanderen', 'country': 'Belgium', 'facility': 'AZ Sint Jan Brugge', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '8900', 'city': 'Ieper', 'state': 'West Vlaanderen', 'country': 'Belgium', 'facility': 'Jan Yperman Ziekenhuis', 'geoPoint': {'lat': 50.85114, 'lon': 2.88569}}, {'zip': '2610', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'GZA Campus Sint Augustinus', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Isabelle Van Herzeele, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vascular surgeon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Research data will not be shared standard'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'collaborators': [{'name': 'Algemeen Ziekenhuis Maria Middelares', 'class': 'OTHER'}, {'name': 'AZ Sint-Jan AV', 'class': 'OTHER'}, {'name': 'Jan Yperman Ziekenhuis', 'class': 'OTHER'}, {'name': 'GZA Ziekenhuizen Campus Sint-Augustinus', 'class': 'OTHER'}, {'name': 'University Hospital, Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}