Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 1,000
- Locations
- 2
- Primary Endpoint
- Operator radiation dose
Study Overview
Brief Summary
Interventional cardiologists are exposed to significant doses of scatter radiation during cardiac catheterization and percutaneous coronary intervention. Traditional methods of reducing the radiation dose for operators in the cardiac catheterization laboratory include limiting the use of radiation, radiation protection aprons and shields, and the use of lead eye glasses. Despite these measures several parts of the operators body, including the head and neck, are poorly screened from scatter radiation. Radiation protection drapes have been developed for use in cardiac catheterization but no randomized controlled study has yet been performed with the commercially available Mavig X-ray Protective Drapes®. The aim of this study is to evaluate operator radiation protection using Mavig X-ray Protective Drapes®.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient undergoing the procedure is older than 18 years and is planned for a coronary angiogram, cardiac catheterization and/or percutaneous coronary intervention.
- •The coronary angiogram/cardiac catheterization/PCI procedure is elective.
- •The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant.
Exclusion Criteria
- •The procedure is an emergency and/or the patient is unstable. -
Arms & Interventions
Study
Intervention: Mavig X-ray Protective Drapes (Other)
Control
Outcomes
Primary Outcomes
Operator radiation dose
Time Frame: Immediate
Gray
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof Dr Walter Desmet
Professor
Universitaire Ziekenhuizen KU Leuven