Radioprotective Light-weight Caps in the Interventional Cardiology Setting

Study Overview
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Brief Summary
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The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps.

Detailed Description
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The primary objective of the present trial is to compare the radiation attenuation provided by XPF caps (0.5mm lead-equivalent and 0.3mm lead-equivalent) to the standard protection (fabric cap, basically no protection) as measured in % radiation attenuation) during 150 days of fluoroscopy guided cardiology interventions. The second objective is to compare the operator comfort (rated on a visual analog scale) of wearing the XPF protection caps compared to the standard fabric caps. For more information please contact Dr. Raul Herrera, MD, Director Baptist Cardiac and Vascular Institute Baptist Hospital of Miami.

Official Title
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Radioprotective Light-weight Caps in the Interventional Cardiology Setting: a Randomized Controlled Trial

Conditions
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Occupational Exposure to Radiation

Intervention / Treatment
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* Device: 0.5mm XPF cap
* Device: 0.3mm XPF cap
* Device: Standard cap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Interventional Cardiologist practicing in Baptist Cardiac & Vascular Institute cardiac procedure requiring C-arm fluoroscopy Exclusion Criteria: Interventional Neuroradiologists and Interventional Radiologists will not be included in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard cap<br>Interventionalist wear a standard fabric cap during fluoroscopy guided interventions. | Device: Standard cap<br>* Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.<br>|
| Experimental: 0.3mm XPF cap<br>Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. | Device: 0.3mm XPF cap<br>* Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.<br>|
| Experimental: 0.5mm XPF cap<br>Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. | Device: 0.5mm XPF cap<br>* Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions. XPF is a trademark of BloXR (Salt lake City, UT) for a new bi-layer (Barium/Bismuth) radiation attenuation material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation Attenuation in Percentage (%) | The null hypothesis is that the XPF 0.5mm lead-equivalent caps attenuation is equal to the XPF 0.3mm lead-equivalent and standard cap attenuations. The alternative hypothesis is that the XPF 0.5mm lead-equivalent cap attenuation is superior or inferior to the XPF 0.3mm lead-equivalent and standard cap attenuations. The groups will be compared separately and a pooled analysis, comparing XPF 0.5mm and 0.3mm combined vs. standard is also planned.The radiation protection (radiation dose reduction) expressed as a percentage was calculated by subtracting radiation measured underneath the cap from radiation measured outside the cap and then dividing this difference by the product of radiation measured outside the cap multiplied by 100. | 1 day | 
| Absolute Radiation Exposure Outside of Cap | The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operator Comfort Assessment | After completion of the last procedure on each day, the operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting). | 1 day per participant, a total of 197 operator days | 
| Operator Comfort Assessment Based on Weight | After completion of the last procedure on each day, the caps worn by the operators were weighed to assess comfort of wearing the standard cap, XPF 0.3mm and XPF 0.5mm caps. The operators were asked to rate the comfort of wearing the cap on a scale from 0 (unbearably heavy, badly fitting) to 100 (very light, well fitting). | 1 day per participant, a total of 197 operator days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occupational Exposure to Radiation