Radioprotective Light-weight Caps in the Interventional Cardiology Setting (PROTECT)

February 4, 2022 updated by: Raul Herrera, MD, Baptist Health South Florida

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33176
        • Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: standard cap
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
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.

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.

EXPERIMENTAL: 0.5mm XPF cap
Interventionalist wear a XPF 0.5mm lead equivalent cap during fluoroscopy guided interventions.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 day per participant, a total of 197 operator days
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).
1 day per participant, a total of 197 operator days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Raul Herrera, MD, Baptist Hospital of Miami, Miami Cardiac and Vascular Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 13, 2012

First Posted (ESTIMATE)

June 15, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • PROTEcT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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