Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a RAD Board
|ClinicalTrials.gov Identifier: NCT02088788|
Recruitment Status : Completed
First Posted : March 17, 2014
Results First Posted : October 24, 2018
Last Update Posted : October 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Radiation Exposure to Operator||Device: Board Device: No Board||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||265 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reduction in Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a Radiation Protection Board|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Experimental: Board (Rad Board")
Radial artery catheterization is performed using radio-opaque armboard
Also has radio-dense pelvic shielding
Other Name: "Rad Board"
Active Comparator: No Board
Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield
Device: No Board
Radio-lucent armboard for radial access with radio-dense drape across pelvis
- Operator Radiation Exposure [ Time Frame: during initial diagnostic catheterization procedure, an average of 30 minutes ]mSieverts radiation dose to the operator during diagnostic catheterization
- Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography [ Time Frame: During procedure, an average of 35 minutes ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088788
|United States, Pennsylvania|
|Geisinger Medical Center|
|Danville, Pennsylvania, United States, 17822|
|Principal Investigator:||James C Blankenship, MD||Geisinger Clinic|