Patients Undergoing Invasive Cardiac Procedures, Radiation Exposure
Conditions
Keywords
Cardiac Catheterization, Percutaneous Coronary Intervention, Radiation, Lead Shielding
Brief summary
The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time.
Interventions
DEVICENovel Lead Based Armboard
Novel Lead Based Armboard
DEVICEStandard Armboard
Standard Armboard (without lead)
Sponsors
Western University, Canada
London Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 * Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone.
Exclusion criteria
* Inability to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation dose (μSv) to the operator at the chest | At procedure completion | Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level. |
| Radiation dose (μSv) to the operator at the forearm level | At procedure completion | Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level. |
Secondary
| Measure | Time frame |
|---|---|
| Air kerma | At procedure completion |
| Dose area product | At procedure completion |
| Radiation dose to the patient | At procedure completion |
Countries
Canada
Outcome results
None listed