N/A
N=197
Radioprotective Light-weight Caps in the Interventional Cardiology Setting
Occupational Exposure to Radiation
Bottom Line
View on ClinicalTrials.gov: NCT01620658 ↗Enrolled (actual)
197
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Radiation Attenuation in Percentage (%) — 12; 91.5; 97.1 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 0.5mm XPF cap (Device); 0.3mm XPF cap (Device); Standard cap (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baptist Health South Florida
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiation Attenuation in Percentage (%) |
12; 91.5; 97.1 | — |
| PRIMARY Absolute Radiation Exposure Outside of Cap |
132; 118; 59 | — |
| SECONDARY Operator Comfort Assessment |
90; 90; 90 | — |
| SECONDARY Operator Comfort Assessment Based on Weight |
12.5; 123.7; 118.4 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01620658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.