Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04063969
• Other study ID #: B670201837824
• Status: Completed
• Start date: January 24, 2019
• Est. completion date: August 20, 2019

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 20, 2019
• Est. primary completion date: August 20, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Endovascular team member group

Inclusion Criteria:

• Vascular surgeon OR surgical trainee OR operating nurse

• Active at one of the participating hospitals

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Healthy Volunteers

Intervention

Other:
• Assessment 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
• Assessment 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
• Assessment 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
• Data 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

Locations

Country	Name	City	State
Belgium	GZA Campus Sint Augustinus	Antwerpen
Belgium	AZ Sint Jan Brugge	Brugge	West Vlaanderen
Belgium	Algemeen Ziekenhuis Maria Middelares	Ghent	Oost Vlaanderen
Belgium	Ghent University Hospital	Ghent	Oost Vlaanderen
Belgium	Jan Yperman Ziekenhuis	Ieper	West Vlaanderen

Sponsors (6)

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

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-assessed radiation safety climate	Radiation safety climate using radiation safety climate tool	Baseline measurement on study inclusion (Day 1)
Primary	Self-assessed radiation safety behavior	Radiation safety behavior using radiation safety behavior tool	Baseline measurement on study inclusion (Day 1)
Primary	Self-assessed radiation safety knowledge and motivation	Radiation safety knowledge and motivation using rating tool	Baseline measurement on study inclusion (Day 1)
Secondary	Procedural radiation doses - Dose area product	Procedural dose area product (DAP)	Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion
Secondary	Procedural radiation doses - cumulative air kerma	Procedural cumulative air kerma (CAK)	Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion
Secondary	Procedural radiation doses - fluoroscopy time	Procedural fluoroscopy time	Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion