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

NCT ID: NCT02088788

Last Updated: 2018-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 265 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-10-31

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.

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.

Conditions

Radiation Exposure to Operator

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Board (Rad Board")

Radial artery catheterization is performed using radio-opaque armboard

Group Type: EXPERIMENTAL

Board

Intervention Type: DEVICE

Also has radio-dense pelvic shielding

No Board

Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield

Group Type: ACTIVE_COMPARATOR

No Board

Intervention Type: DEVICE

Radio-lucent armboard for radial access with radio-dense drape across pelvis

Interventions

Board

Also has radio-dense pelvic shielding

Intervention Type: DEVICE

No Board

Radio-lucent armboard for radial access with radio-dense drape across pelvis

Intervention Type: DEVICE

Other Intervention Names

"Rad Board"

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geisinger Clinic

OTHER

Sponsor Role: lead

Responsible Party

James C. Blankenship

Director of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James C Blankenship, MD

Role: PRINCIPAL_INVESTIGATOR

Geisinger Clinic

Locations

Geisinger Medical Center

Danville, Pennsylvania, United States

Countries

United States

Other Identifiers

2013-0140

Identifier Type: -

Identifier Source: org_study_id