Radiation Exposure
Conditions
Brief summary
The purpose of this study is to examine the impact of the RADPAD in proximal operators in a contemporary cardiac catheterization laboratory (CCL), during diagnostic, coronary and structural cardiac catheterization procedures, in a large prospective, randomized controlled trial. Up to 1,000 patient-cases and up to 100 proximal operator-subjects expected to be enrolled across 1 site. The proximal operator cohort is expected to include a few interventional cardiologist attending physicians, interventional cardiology fellows, cardiovascular disease fellows and physician assistants performing multiple cases each, which in total would amount to 1,000 cases performed by 100 proximal operators. The primary outcome of interest was relative exposure of the proximal operator between the guideline directed radiation protocols and RADPAD use vs. guideline directed radiation protocols alone.
Interventions
DEVICERADPAD
The RADPAD protection drape was designed as a protective scatter-radiation absorbing shield with the goal of reducing scatter radiation. It is a sterile, lead free, light weight, and disposable radiation protection shield that is placed directly over the sterile patient drapes. The RADPAD is comprised of antimony and bismuth providing protection during low-energy fluoroscopy and high-energy cine and Digital subtraction angiography (DSA) settings.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(Employees): * Proximal operator of a cardiac catheterization procedure as defined by the individual performing the procedure closest to the source of radiation. This may be either physician assistants of the CCL, fellows of cardiovascular disease, interventional cardiology fellows or attending interventional cardiologists at NYU Langone Hospital - Long Island. * Age ≥18 years * Willing and able to consent. Inclusion Criteria (Patient Cases): * Cardiac catheterization procedure at NYU Langone Hospital - Long Island. * Age ≥18 years of the patient undergoing cardiac catheterization.
Exclusion criteria
(Employees): * Anyone unable or unwilling to give informed consent. * Anyone pregnant or breastfeeding. * A proximal operator performing a cardiac catheterization procedure where there are not located on the right-side of the patient and/or behind the radiation shield. * Any proximal operator who wishes to use the RADPAD regardless of being in the study/is unwilling to be randomized
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operator Exposure (OE)/Dose Area Product (DAP) (uSv[Micro-Sieverts]/mGy[Milligray]*cm2) of the Proximal Operator | From start of each procedure until end of each procedure (up to 1 day) | This is a continuous variable which will be analyzed statistically using the student's t-test. |
| OE/DAP (uSv/mGy*cm2) of the Proximal Operator | From start of each procedure until end of each procedure (up to 1 day) | This is a continuous variable which will be analyzed statistically using the student's t-test. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGiorgio A. Medranda, MD
NYU Langone Health
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 6.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1000 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 500 participants |
| Sex: Female, Male Female | 205 Participants |
| Sex: Female, Male Male | 295 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed