Radioprotective Light-weight Caps in the Interventional Cardiology Setting

Overview

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.

Full Title of Study: “Radioprotective Light-weight Caps in the Interventional Cardiology Setting: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: March 2014

Detailed Description

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.

Interventions

  • Device: 0.5mm XPF cap
    • 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.
  • Device: 0.3mm XPF cap
    • 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.
  • Device: Standard cap
    • Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.

Arms, Groups and Cohorts

  • Active Comparator: standard cap
    • Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
  • Experimental: 0.3mm XPF cap
    • Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.
  • Experimental: 0.5mm XPF cap
    • Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.

Clinical Trial Outcome Measures

Primary Measures

  • Radiation Attenuation in Percentage (%)
    • Time Frame: 1 day
    • 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.
  • Absolute Radiation Exposure Outside of Cap
    • Time Frame: 1 day
    • The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured.

Secondary Measures

  • Operator Comfort Assessment
    • Time Frame: 1 day per participant, a total of 197 operator days
    • 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).
  • Operator Comfort Assessment Based on Weight
    • Time Frame: 1 day per participant, a total of 197 operator days
    • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Baptist Health South Florida
  • Provider of Information About this Clinical Study
    • Principal Investigator: Raul Herrera, MD, Director, Division of Clinical Research & Outcomes – Baptist Health South Florida
  • Overall Official(s)
    • Raul Herrera, MD, Principal Investigator, Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Citations Reporting on Results

Uthoff H, Quesada R, Roberts JS, Baumann F, Schernthaner M, Zaremski L, Hajirawala L, Katzen BT, Staub D, Kreusch AS. Radioprotective lightweight caps in the interventional cardiology setting: a randomised controlled trial (PROTECT). EuroIntervention. 2015 May;11(1):53-9. doi: 10.4244/EIJV11I1A9.

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