Clinical trial NCT02088788: Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a RAD Board
Official title: Reduction in Physician Radiation Exposure During Radial Access Cardiac Catheterization Using a Radiation Protection Board
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Exposure to Operator
Keywords: radiation
radiation injury
occupational risk
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Operator Radiation Exposure
timeFrame: during initial diagnostic catheterization procedure, an average of 30 minutes
Secondary outcomes:
measure: Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography
timeFrame: During procedure, an average of 35 minutes
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: James C Blankenship, MD
role: PRINCIPAL_INVESTIGATOR
References: