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Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite

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ClinicalTrials.gov Identifier: NCT04063969
Recruitment Status : Active, not recruiting
First Posted : August 21, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborators:
Algemeen Ziekenhuis Maria Middelares
AZ Sint-Jan AV
Jan Yperman Ziekenhuis
GZA Ziekenhuizen Campus Sint-Augustinus
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Healthy Volunteers Aortic Aneurysm, Abdominal Other: Assessment of radiation safety climate Other: Assessment of radiation safety behavior Other: Assessment of radiation safety knowledge and motivation Other: Data collection

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.

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Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite and Its Effects on Radiation Safety Performance
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : August 20, 2019
Estimated Study Completion Date : August 20, 2019

Group/Cohort Intervention/treatment
Endovascular team members

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.

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

Other Name: Radiation safety climate rating tool

Other: 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
Other Name: Radiation safety behavior rating tool

Other: 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

Other Name: Radiation safety knowledge and motivation rating tool

Vascular surgical patients

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.

Other: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
  • Endovascular team members: vascular surgeons, surgical trainees, operating nurses
  • Patients undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm
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 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063969


Locations
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Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, Oost Vlaanderen, Belgium, 9000
Ghent University Hospital
Ghent, Oost Vlaanderen, Belgium, 9000
AZ Sint Jan Brugge
Brugge, West Vlaanderen, Belgium, 8000
Jan Yperman Ziekenhuis
Ieper, West Vlaanderen, Belgium, 8900
GZA Campus Sint Augustinus
Antwerpen, Belgium, 2610
Sponsors and Collaborators
University Ghent
Algemeen Ziekenhuis Maria Middelares
AZ Sint-Jan AV
Jan Yperman Ziekenhuis
GZA Ziekenhuizen Campus Sint-Augustinus
Investigators
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Principal Investigator: Isabelle Van Herzeele, MD, PhD Vascular surgeon

Publications:
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT04063969     History of Changes
Other Study ID Numbers: B670201837824
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Research data will not be shared standard

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Ghent:
Radiation safety
Radiation safety climate
Radiation safety behavior
Quality improvement
Patient safety
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases