Healthy VolunteersNCT04063969
Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite
An observational study of Healthy Volunteers and Aortic Aneurysm, Abdominal, run by University Ghent at 5 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy Volunteers, Aortic Aneurysm, Abdominal
- What is being tested?
- Assessment of radiation safety climate, Assessment of radiation safety behavior and Assessment of radiation safety knowledge and motivation
- How many people
- 92 participants
- Where
- 5 sitesBelgium
- Study dates
- 24 Jan 2019to 20 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: * Endovascular team members: vascular surgeons, surgical trainees, operating nurses * Patients undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm
Who may be able to join
- Vascular surgeon OR surgical trainee OR operating nurse
- Active at one of the participating hospitals
Who cannot join
- No exclusion criteria apply to this study.
- Patient group Inclusion Criteria
- Patient undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm
- Emergency repair (ruptured aneurysm)
- Additional interventional procedures (iliac aneurysm, treatment of peripheral vessel disease)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
GZA Campus Sint Augustinus
Antwerp, 2610
AZ Sint Jan Brugge
Bruges, West Vlaanderen, 8000
Algemeen Ziekenhuis Maria Middelares
Ghent, Oost Vlaanderen, 9000
Ghent University Hospital
Ghent, Oost Vlaanderen, 9000
Jan Yperman Ziekenhuis
Ieper, West Vlaanderen, 8900
About this study
Official title: Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite and Its Effects on Radiation Safety Performance
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.
Read the 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.
- Conditions
- Healthy Volunteers, Aortic Aneurysm, Abdominal
- Being tested
- Assessment of radiation safety climate, Assessment of radiation safety behavior, Assessment of radiation safety knowledge and motivation, Data collection
- Keywords
- Radiation safety, Radiation safety climate, Radiation safety behavior, Quality improvement, Patient safety
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of radiation safety climateOther
Also called Radiation safety climate rating tool
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 behaviorOther
Also called Radiation safety behavior rating tool
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 motivationOther
Also called Radiation safety knowledge and motivation rating tool
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 collectionOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-assessed radiation safety climate
Radiation safety climate using radiation safety climate tool
Measured: Baseline measurement on study inclusion (Day 1)
Self-assessed radiation safety behavior
Radiation safety behavior using radiation safety behavior tool
Measured: Baseline measurement on study inclusion (Day 1)
Self-assessed radiation safety knowledge and motivation
Radiation safety knowledge and motivation using rating tool
Measured: Baseline measurement on study inclusion (Day 1)
Secondary outcomes (3)
Procedural radiation doses - Dose area product
Procedural dose area product (DAP)
Measured: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion
Procedural radiation doses - cumulative air kerma
Procedural cumulative air kerma (CAK)
Measured: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion
Procedural radiation doses - fluoroscopy time
Procedural fluoroscopy time
Measured: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start24 Jan 2019
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Algemeen Ziekenhuis Maria Middelares, AZ Sint-Jan AV, Jan Yperman Ziekenhuis, GZA Ziekenhuizen Campus Sint-Augustinus, University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Isabelle Van Herzeele, MD, PhD, Principal investigator, Vascular surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063969
- Sponsor's protocol ID
- B670201837824
- Status last verified
- Nov 2021
- First submitted
- 14 Aug 2019
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research data will not be shared standard
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. doi: 10.1037//1076-8998.5.3.347.
PubMed 10912498
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Radiation Safety Climate in the Hybrid Angiography Suite and Its Effects on Radiation Safety Performance
- ClinicalTrials.gov ID
- NCT04063969
- Acronym / sponsor ID
- B670201837824
- Conditions
- Healthy Volunteers, Aortic Aneurysm, Abdominal
- Keywords
- Radiation safety, Radiation safety climate, Radiation safety behavior, Quality improvement, Patient safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Algemeen Ziekenhuis Maria Middelares, AZ Sint-Jan AV, Jan Yperman Ziekenhuis, GZA Ziekenhuizen Campus Sint-Augustinus, University Hospital, Ghent
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular team members | – | Other: Assessment of radiation safety climate, Other: Assessment of radiation safety behavior, Other: Assessment of radiation safety knowledge and motivationAll 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. |
| Vascular surgical patients | – | Other: Data collectionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Endovascular team members: vascular surgeons, surgical trainees, operating nurses * Patients undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm
Key inclusion criteria (2 listed)
- Vascular surgeon OR surgical trainee OR operating nurse
- Active at one of the participating hospitals
Key exclusion criteria (5 listed)
- No exclusion criteria apply to this study.
- Patient group Inclusion Criteria
- Patient undergoing elective endovascular repair of infrarenal abdominal aortic aneurysm
- Emergency repair (ruptured aneurysm)
- Additional interventional procedures (iliac aneurysm, treatment of peripheral vessel disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of radiation safety climateAlso: Radiation safety climate rating toolThe 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 | Endovascular team members |
| Assessment of radiation safety behaviorAlso: Radiation safety behavior rating toolThe 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 | Endovascular team members |
| Assessment of radiation safety knowledge and motivationAlso: Radiation safety knowledge and motivation rating toolThe 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 | Endovascular team members |
| Data collectionCollection 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 | Other | Vascular surgical patients |
Primary outcome
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
3 secondary outcomes
Procedural radiation doses - Dose area product
Time frame: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion
Procedural radiation doses - cumulative air kerma
Time frame: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion
Procedural radiation doses - fluoroscopy time
Time frame: Registration during endovascular EVAR procedure - Within 1 week after patient study inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- Background: PubMed 10912498Griffin 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. doi: 10.1037//1076-8998.5.3.347.
- Individual participant dataSharing planned: No. Research data will not be shared standard
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Van Herzeele, MD, PhD principal investigator
Vascular surgeon
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Aortic Aneurysm, Abdominal, run by University Ghent at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-assessed radiation safety climate (time frame: Baseline measurement on study inclusion (Day 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04063969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.