Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date August 14, 2019
First Posted Date August 21, 2019
Last Update Posted Date August 21, 2019
Actual Study Start Date January 24, 2019
Estimated Primary Completion Date August 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 19, 2019)
  • Self-assessed radiation safety climate [ Time Frame: Baseline measurement on study inclusion (Day 1) ]
    Radiation safety climate using radiation safety climate tool
  • Self-assessed radiation safety behavior [ Time Frame: Baseline measurement on study inclusion (Day 1) ]
    Radiation safety behavior using radiation safety behavior tool
  • Self-assessed radiation safety knowledge and motivation [ Time Frame: Baseline measurement on study inclusion (Day 1) ]
    Radiation safety knowledge and motivation using rating tool
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 19, 2019)
  • 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)
  • 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)
  • Procedural radiation doses - fluoroscopy time [ Time Frame: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion ]
    Procedural fluoroscopy time
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite
Official Title Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite and Its Effects on Radiation Safety Performance
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Healthy Volunteers
  • Aortic Aneurysm, Abdominal
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

    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
  • 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
Study Groups/Cohorts
  • 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.

    Interventions:
    • Other: Assessment of radiation safety climate
    • Other: Assessment of radiation safety behavior
    • Other: Assessment of radiation safety knowledge and motivation
  • 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.

    Intervention: Other: Data collection
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 19, 2019)
92
Original Actual Enrollment Same as current
Estimated Study Completion Date August 20, 2019
Estimated Primary Completion Date August 20, 2019   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT04063969
Other Study ID Numbers B670201837824
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Research data will not be shared standard
Responsible Party University Ghent
Study Sponsor University Ghent
Collaborators
  • Algemeen Ziekenhuis Maria Middelares
  • AZ Sint-Jan AV
  • Jan Yperman Ziekenhuis
  • GZA Ziekenhuizen Campus Sint-Augustinus
Investigators
Principal Investigator: Isabelle Van Herzeele, MD, PhD Vascular surgeon
PRS Account University Ghent
Verification Date August 2019