Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite
- Conditions
- Healthy VolunteersAortic Aneurysm, Abdominal
- Interventions
- Other: Assessment of radiation safety climateOther: Data collectionOther: Assessment of radiation safety behaviorOther: Assessment of radiation safety knowledge and motivation
- Registration Number
- NCT04063969
- Lead Sponsor
- University Ghent
- Brief Summary
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.
The 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- Vascular surgeon OR surgical trainee OR operating nurse
- Active at one of the participating hospitals
- No exclusion criteria apply to this study.
Patient group Inclusion Criteria
- Patient undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm
Exclusion criteria
- Emergency repair (ruptured aneurysm)
- Additional interventional procedures (iliac aneurysm, treatment of peripheral vessel disease)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Endovascular team members Assessment of radiation safety knowledge and motivation 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. All 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. Endovascular team members Assessment of radiation safety climate 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. All 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. Endovascular team members Assessment of radiation safety behavior 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. All 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. Vascular surgical patients Data collection In each center, five patients undergoing primary elective endovascular repair for an infrarenal abdominal aortic aneurysm (EVAR) will be enrolled in the study. For 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. Participation in this study has no effect on the interventional procedure, or the chosen approach.
- Primary Outcome Measures
Name Time Method Self-assessed radiation safety climate Baseline measurement on study inclusion (Day 1) Radiation safety climate using radiation safety climate tool
Self-assessed radiation safety behavior Baseline measurement on study inclusion (Day 1) Radiation safety behavior using radiation safety behavior tool
Self-assessed radiation safety knowledge and motivation Baseline measurement on study inclusion (Day 1) Radiation safety knowledge and motivation using rating tool
- Secondary Outcome Measures
Name Time Method Procedural radiation doses - Dose area product Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion Procedural dose area product (DAP)
Procedural radiation doses - cumulative air kerma Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion Procedural cumulative air kerma (CAK)
Procedural radiation doses - fluoroscopy time Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion Procedural fluoroscopy time
Trial Locations
- Locations (5)
Algemeen Ziekenhuis Maria Middelares
🇧🇪Ghent, Oost Vlaanderen, Belgium
Jan Yperman Ziekenhuis
🇧🇪Ieper, West Vlaanderen, Belgium
GZA Campus Sint Augustinus
🇧🇪Antwerpen, Belgium
Ghent University Hospital
🇧🇪Ghent, Oost Vlaanderen, Belgium
AZ Sint Jan Brugge
🇧🇪Brugge, West Vlaanderen, Belgium