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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088788
Recruitment Status : Completed
First Posted : March 17, 2014
Results First Posted : October 24, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
James C. Blankenship, Geisinger Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Radiation Exposure to Operator Device: Board Device: No Board Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Board (Rad Board")
Radial artery catheterization is performed using radio-opaque armboard
Device: Board
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




Primary Outcome Measures :
  1. Operator Radiation Exposure [ Time Frame: during initial diagnostic catheterization procedure, an average of 30 minutes ]
    mSieverts radiation dose to the operator during diagnostic catheterization


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088788


Locations
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United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Sponsors and Collaborators
Geisinger Clinic
Investigators
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Principal Investigator: James C Blankenship, MD Geisinger Clinic
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Responsible Party: James C. Blankenship, Director of Cardiology, Geisinger Clinic
ClinicalTrials.gov Identifier: NCT02088788    
Other Study ID Numbers: 2013-0140
First Posted: March 17, 2014    Key Record Dates
Results First Posted: October 24, 2018
Last Update Posted: October 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by James C. Blankenship, Geisinger Clinic:
radiation
radiation injury
occupational risk