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Completed

NCT Number: NCT02088788

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

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Key information

Conditions

Radiation Exposure to Operator Radiation Injuries Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Board

Device

Also has radio-dense pelvic shielding

Other names: "Rad Board"

No Board

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2014
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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