Measuring scatter radiation exposure during coronary procedures
Quantification and Determinants of Occupational Xray Scatter Radiation Exposure of Operators and Assistants During Coronary Procedures - The Occupational SCAtter Radiation Registry
This study looks at how much scatter radiation doctors and assistants get during heart procedures to see if new protective devices can help reduce their exposure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Paracelsus Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Salzburg) |
| Trial ID | NCT04945538 on ClinicalTrials.gov |
What this trial studies
This observational registry collects data on scatter radiation exposure experienced by operators and sterile assistants during diagnostic and interventional coronary procedures. Using digital live dosimeters, the study records radiation exposure at specific anatomical locations and correlates this data with detailed X-ray exposure metrics and technical aspects of the procedures. The aim is to establish reference values for scatter radiation, identify factors that contribute to high exposure, and evaluate the effectiveness of advanced radiation protection devices in clinical settings.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for coronary angiography or percutaneous coronary interventions, both elective and acute.
Not a fit: Patients who are not undergoing coronary procedures or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance radiation safety protocols, ultimately reducing exposure for healthcare workers during coronary procedures.
How similar studies have performed: While there have been studies on radiation exposure in medical settings, this specific approach to systematically collect and analyze scatter radiation data is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient scheduled for coronary angiography * Diagnostic procedure and PCI * Acute and elective procedures * Standard percutaneous coronary interventions (PCI) interventions * Chronic total occlusion (CTO) interventions * Set of at least 4 personal digital live dosimeters (PDL) worn by operator and sterile assistant for the entire duration of the procedure * Staff (operators and assistants) instructed on PDL positioning prior to procedure Exclusion Criteria: * Less than 4 PDL present during the procedure * Incomplete data recording by at least 1 PDL * PDL data cannot be unambiguously assigned to a specific procedure or a specific anatomical recording site * Exchange of operator or assistant during procedure without transfer of all PDL
Where this trial is running
Salzburg
- Paracelsus Medical University, Clinic II of Internal Medicine — Salzburg, Austria (Recruiting)
Study contacts
- Study coordinator: Mathias C. Brandt, MD
- Email: m.brandt@salk.at
- Phone: +43-5-7255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.