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

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

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.

Study Overview

• Status: Completed
• Conditions: Radiation Exposure to Operator
• Intervention / Treatment: Device: Board; Device: No Board

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 Type: Interventional
• Enrollment (Actual): 265
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: "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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Investigators: Principal Investigator: James C Blankenship, MD, Geisinger Clinic

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: March 13, 2014
• First Submitted That Met QC Criteria: March 14, 2014
• First Posted (Estimate): March 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: radiation; radiation injury; occupational risk
• Other Study ID Numbers: 2013-0140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO