Radioprotective Light-weight Caps in the Interventional Cardiology Setting

Occupational Exposure to Radiation Clinical Trial

— PROTECT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620658
• Other study ID #: PROTECT
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: April 2014

Study information

• Verified date: September 2021
• Source: Baptist Health South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Occupational Exposure to Radiation

Intervention

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.
• 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.
• Standard cap
Interventionalist wear a standard fabric cap during fluoroscopy guided interventions.

Locations

Country	Name	City	State
United States	Baptist Hospital of Miami, Miami Cardiac and Vascular Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Baptist Health South Florida

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Absolute Radiation Exposure Outside of Cap	The cumulative radiation doses were defined as the summation of all correspondent equivalent doses measured.	1 day
Secondary	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
Secondary	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