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
• Sponsor: Geisinger Clinic
• Information provided by (Responsible Party): James C. Blankenship, Geisinger Clinic

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Pennsylvania

Geisinger Medical Center

Danville, Pennsylvania, United States, 17822

Sponsors and Collaborators

Geisinger Clinic

Investigators

• Principal Investigator: James C Blankenship, MD; Geisinger Clinic

More Information

• 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
• 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