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Completed

NCT Number: NCT04063969

Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Algemeen Ziekenhuis Maria Middelares, Ghent, Oost Vlaanderen, Belgium

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Assessment of radiation safety climate

Other

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

Other names: Radiation safety climate rating tool

Assessment of radiation safety behavior

Other

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

Other names: Radiation safety behavior rating tool

Assessment of radiation safety knowledge and motivation

Other

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

Other names: Radiation safety knowledge and motivation rating tool

Data Collection

Other

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

Primary outcomes

  1. Self-assessed radiation safety climate

    Time frame: Baseline measurement on study inclusion (Day 1)

    Radiation safety climate using radiation safety climate tool

  2. Self-assessed radiation safety behavior

    Time frame: Baseline measurement on study inclusion (Day 1)

    Radiation safety behavior using radiation safety behavior tool

  3. Self-assessed radiation safety knowledge and motivation

    Time frame: Baseline measurement on study inclusion (Day 1)

    Radiation safety knowledge and motivation using rating tool

Secondary outcomes

  1. Procedural radiation doses - Dose area product

    Time frame: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion

    Procedural dose area product (DAP)

  2. Procedural radiation doses - cumulative air kerma

    Time frame: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion

    Procedural cumulative air kerma (CAK)

  3. Procedural radiation doses - fluoroscopy time

    Time frame: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion

    Procedural fluoroscopy time

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2019
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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