Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a RAD Board

Study Overview
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Brief Summary
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Radiation exposure to operator is an occupational hazard of invasive cardiologists. During radial access for diagnostic catheterization, a new radio-dense arm board is advertised to reduce operator radiation exposure. The investigators randomize patients to a new radio-dense armboard versus a standard radio-transparent armboard during diagnostic catheterization and measure radiation exposure to the operator. Both groups have a radio-dense pelvic shield in place. The investigators hypothesize that operator radiation dose will be decreased by use of the radio-dense armboard.

Detailed Description
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Hypothesis: Compared to standard shielding with a lead pelvic drape alone, using a radio-opaque arm board in addition to the pelvic drape will decrease operator radiation exposure during radial access cardiac catheterization by at least 30%. STUDY DESIGN This is a randomized, prospective study where patients will be randomized by random numbers in sealed envelopes to standard shielding (pelvic drape alone, the no-board group) or to experimental shielding (pelvic drape plus radiation board, the board group). A robust radiation safety monitoring program is in place. Patient exposure is measured by the catheterization laboratory equipment and recorded. Lindauer Microstar Nanodot badges worn at waist level above the radiation lead will be used to measure operator radiation exposure. A new Nanodot will be used for every case. Radiation exposure to the operator's Nanodot will be measured immediately after each procedure by a technician blinded to study assignment. All patients 18-89 years old presenting to Geisinger Medical Center for diagnostic cardiac catheterization will be evaluated for the study. All interventional or diagnostic cardiologists and fellows that will be performing the cardiac catheterization procedure also will be study subjects. Approximately 215 Geisinger patients who satisfy inclusion and exclusion criteria will be included. Approximately 6 interventional cardiologists, 2 diagnostic cardiologists and 10 fellows will be included in this study.

Official Title
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Reduction in Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a Radiation Protection Board

Conditions
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Radiation Exposure to Operator

Intervention / Treatment
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* Device: Board
* Device: No Board


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Operators: Interventional or diagnostic interventional attendings and fellows, operators willing to participate. Patients: Age 18-89 years old requiring catheterization at Geisinger Medical Center using radial access Exclusion Criteria: patients with CABG, requiring extensive imaging, with operator switch during the procedure patients in whom the procedure took unusual time because of anatomic issues, and need to switch to alternative access.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Board (Rad Board)<br>Radial artery catheterization is performed using radio-opaque armboard | Device: Board<br>* Also has radio-dense pelvic shielding<br>* Other names: Rad Board;|
| Active Comparator: No Board<br>Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield | Device: No Board<br>* Radio-lucent armboard for radial access with radio-dense drape across pelvis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operator Radiation Exposure | mSieverts radiation dose to the operator during diagnostic catheterization | during initial diagnostic catheterization procedure, an average of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography | mSieverts radiation dose to the operator during diagnostic catheterization with versus without ventriculography/aortography. This outcome measure includes 2 types of procedures: diagnostic catheterization plus LV gram and diagnostic catheterization plus aortography. Ventriculography is defined as injection through a pigtail catheter into the left ventricle using a power injector. Aortography is defined as injection through a pigtail catheter into the aorta using a power injector. | During procedure, an average of 35 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation, radiation injury, occupational risk