Radiation Exposure to Operator
Conditions
Keywords
radiation, radiation injury, occupational risk
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.
Interventions
DEVICEBoard
Also has radio-dense pelvic shielding
DEVICENo Board
Radio-lucent armboard for radial access with radio-dense drape across pelvis
Sponsors
Geisinger Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operator Radiation Exposure | during initial diagnostic catheterization procedure, an average of 30 minutes | mSieverts radiation dose to the operator during diagnostic catheterization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Board (Rad Board) Radial artery catheterization is performed using radio-opaque armboard
Board: Also has radio-dense pelvic shielding | 105 |
| No Board Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield
No Board: Radio-lucent armboard for radial access with radio-dense drape across pelvis | 89 |
| Total | 194 |
Baseline characteristics
| Characteristic | Board (Rad Board) | No Board | Total |
|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 12.1 | 64.2 years STANDARD_DEVIATION 9.5 | 64.5 years STANDARD_DEVIATION 10.94 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 37 Participants | 38 Participants | 75 Participants |
| Sex: Female, Male Male | 68 Participants | 51 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Operator Radiation Exposure
mSieverts radiation dose to the operator during diagnostic catheterization
Time frame: during initial diagnostic catheterization procedure, an average of 30 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Board (Rad Board) | Operator Radiation Exposure | .65 mSv |
| No Board | Operator Radiation Exposure | .56 mSv |
Secondary
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.
Time frame: During procedure, an average of 35 minutes
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Board (Rad Board) | Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography | With Ventriculogram/aortogram | .65 mSv |
| Board (Rad Board) | Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography | Without ventriculogram/aortogram | .66 mSv |
| No Board | Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography | With Ventriculogram/aortogram | .61 mSv |
| No Board | Radiation Exposure to Operator During Diagnostic Catheterization With Versus Without Ventriculography/Aortography | Without ventriculogram/aortogram | .54 mSv |