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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Raul Herrera, MD, Baptist Health South Florida
ClinicalTrials.gov Identifier:
NCT01620658
First received: June 6, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Occupational Exposure to Radiation
Device: 0.5mm XPF cap
Device: 0.3mm XPF cap
Device: Standard cap

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Official Title: Radioprotective Light-weight Caps in the Interventional Cardiology Setting: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Baptist Health South Florida:

Primary Outcome Measures:
  • Radiation attenuation in percentage (%) [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Radiation attenuation in absolute terms (uSv) [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • Wearing comfort of the collar on a scale from 0-100. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Operators are asked directly after the procedures to rate the wearing comfort


Estimated Enrollment: 150
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard cap
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.
Device: 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.
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.

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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620658

Locations
United States, Florida
Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute
Miami, Florida, United States, 33176
Sponsors and Collaborators
Baptist Health South Florida
Investigators
Principal Investigator: Heiko Uthoff, MD Baptist Hospital of Miami, Baptist Cardiac and Vascular Institute
  More Information

No publications provided

Responsible Party: Raul Herrera, MD, Director, Division of Clinical Research & Outcomes, Baptist Health South Florida
ClinicalTrials.gov Identifier: NCT01620658     History of Changes
Other Study ID Numbers: PROTECT
Study First Received: June 6, 2012
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Baptist Health South Florida:
Occupational Exposure to Radiation

ClinicalTrials.gov processed this record on September 16, 2014