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

Baptist Health South Florida

Status: Completed

Conditions: Occupational Exposure to Radiation

Treatments: Device: 0.5mm XPF cap; Device: Standard cap; Device: 0.3mm XPF cap

Study type: Interventional

Funder types: Other

Identifiers

NCT01620658

PROTECT

Details and patient eligibility

About

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 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.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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197 participants in 3 patient groups

standard cap

Active Comparator group

Description:

Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.

Treatment:

Device: Standard cap

0.3mm XPF cap

Experimental group

Description:

Interventionalist wear a XPF 0.3mm lead equivalent cap during fluoroscopy guided interventions.

Treatment:

Device: 0.3mm XPF cap

0.5mm XPF cap

Experimental group

Description:

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

Treatment:

Device: 0.5mm XPF cap