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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Board (Rad Board") | Experimental | Radial artery catheterization is performed using radio-opaque armboard |
|
| No Board | Active Comparator | Regular radio-penetrating armboard is used (the one normally used during non-study procedures) with a radio-opaque pelvic shield |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Board | Device | Also has radio-dense pelvic shielding |
|
| 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 |
| 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| James C Blankenship, MD | Geisinger Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Board (Rad Board") | Radial artery catheterization is performed using radio-opaque armboard Board: Also has radio-dense pelvic shielding |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Board (Rad Board") | Radial artery catheterization is performed using radio-opaque armboard Board: Also has radio-dense pelvic shielding |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Operator Radiation Exposure | mSieverts radiation dose to the operator during diagnostic catheterization | Posted | Median | Inter-Quartile Range | mSv | during initial diagnostic catheterization procedure, an average of 30 minutes |
|
Adverse events were not collected for this study. Consent was not obtained from patients since no experimental procedures involved patients.
Adverse events were not collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Board (Rad Board") | Radial artery catheterization is performed using radio-opaque armboard Board: Also has radio-dense pelvic shielding |
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We excluded post hoc procedures that required prolonged imaging. This resulted in unequal sizes of the board and no-board groups. As a single-center trial, results may not be generalizable to cath labs with different radiation protection set-ups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Troup | Geisinger | 570-214-5433 | matroup@geisinger.edu |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D003143 | Communication Devices for People with Disabilities |
| ID | Term |
|---|---|
| D012656 | Self-Help Devices |
| D004864 | Equipment and Supplies |
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| No Board | Device | Radio-lucent armboard for radial access with radio-dense drape across pelvis |
|
| During procedure, an average of 35 minutes |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Median | Inter-Quartile Range | mSv | During procedure, an average of 35 minutes |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 |
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