Coronary Interventions, Radiation; Exposure Occupational
Conditions
Brief summary
The RECAP-trial is a randomized controlled, double blinded, superiority trial studying the efficacy of the RADPAD®, a protective drape, that potentially reduces the scattered radiation received by the operator during diagnostic angiograms and percutaneous coronary interventions.
Detailed description
A total of 750 consecutive diagnostic angiograms and percutaneous coronary interventions were randomly assigned to the radiation-attenuating (RADPAD®), a dummy drape or a control group in a 1:1:1 ratio. The drapes will be used in addition to conventional shielding material. Primary radiation exposure is measured blindly by a dose aware meter (Philips) positioned at a set location on the operator. Radiation exposure is measured by the X-ray systems (DAP in Gy·cm2). The primary outcome is the effective dose received by the first operator (mSv/Gy·cm2).
Interventions
DEVICE(sham) radiation absorbing drape (RADPAD®)
Sponsors
J.P.S Henriques
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Patient, operator and investigator are blinded to dummy drape vs RADPAD.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All CAGs and PCI's
Exclusion criteria
* Other interventional procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary operator radiation exposure (mSv) | immediately post-procedure |
Countries
Netherlands
Outcome results
None listed