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Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite

Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite and Its Effects on Radiation Safety Performance

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04063969
Enrollment
92
Registered
2019-08-21
Start date
2019-01-24
Completion date
2019-08-20
Last updated
2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Abdominal, Healthy Volunteers

Keywords

Radiation safety, Radiation safety climate, Radiation safety behavior, Quality improvement, Patient safety

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.

Interventions

OTHERAssessment of radiation safety climate

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. Minimum scale score 28 - Maximum scale score 140

OTHERAssessment of radiation safety behavior

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

OTHERAssessment of radiation safety knowledge and motivation

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. Minimum item score 1 - maximum item score 5

OTHERData collection

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

Sponsors

Algemeen Ziekenhuis Maria Middelares
CollaboratorOTHER
AZ Sint-Jan AV
CollaboratorOTHER
Jan Yperman Ziekenhuis
CollaboratorOTHER
GZA Ziekenhuizen Campus Sint-Augustinus
CollaboratorOTHER
University Hospital, Ghent
CollaboratorOTHER
University Ghent
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

Endovascular team member group Inclusion Criteria: * Vascular surgeon OR surgical trainee OR operating nurse * Active at one of the participating hospitals

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
Self-assessed radiation safety climateBaseline measurement on study inclusion (Day 1)Radiation safety climate using radiation safety climate tool
Self-assessed radiation safety behaviorBaseline measurement on study inclusion (Day 1)Radiation safety behavior using radiation safety behavior tool
Self-assessed radiation safety knowledge and motivationBaseline measurement on study inclusion (Day 1)Radiation safety knowledge and motivation using rating tool

Secondary

MeasureTime frameDescription
Procedural radiation doses - Dose area productRegistration during endovascular EVAR procedure - Within 1 week after patient study inclusionProcedural dose area product (DAP)
Procedural radiation doses - cumulative air kermaRegistration during endovascular EVAR procedure - Within 1 week after patient study inclusionProcedural cumulative air kerma (CAK)
Procedural radiation doses - fluoroscopy timeRegistration during endovascular EVAR procedure - Within 1 week after patient study inclusionProcedural fluoroscopy time

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026