Scatter Radiation Exposure During Coronary Procedures - The Occupational SCAtter Radiation Registry

Study Overview
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Brief Summary
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During diagnostic and interventional coronary procedures scatter radiation exposure is recorded with live-dosimeters at pre-specified anatomic regions of operators and sterile assistants. Scatter radiation data is correlated with detailed Xray exposure data and technical details of the procedure. The purpose of the registry is: to establish scatter radiation reference values based on a large number of representative cath-lab procedures to identify technical and clinical factors predisposing for high scatter radiation exposure, to evaluate advanced radiation protection devices in clinical routine.

Detailed Description
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Patients scheduled for diagnostic or interventional coronary procedures provide written informed consent for participating in the observational OSCAR Registry. During the corresponding procedures, scatter radiation exposure of operators and sterile assistants is recorded using Unfors RaySafe i3 digital live dosimeters (Unfors RaySafe AB, Billdal, Sweden) at 3 locations of the operator (1-frontal head at eye level, 2-left lateral head, 3-below the left shoulder) and at 2 locations of the sterile assistant (1-left neck and 2-below the left shoulder). Raw data is collected in a central database and correlated with patient properties (age, BMI) and detailed Xray exposure data: Total dose-area product (DAP, unit of measure: Gy*cm2) Number of Xray image series Number of Images Radiation duration (Unit of measure: Seconds) Air kinetic energy released per unit mass (Kerma) Technical details of the procedure Access site, Clinical setting: acute or elective Number of catheters used during procedure Number of guidewires used during procedure Number of stents implanted during procedure Cumulative stent length (Unit of measure: mm) Use of rotational imaging Use of intracoronary pressure-wire Use of optical coherence tomography (OCT) Presence of bypass-vessels Any occurrence of complications The purpose of the trial is to establish a large foundation of intra-procedural scatter radiation data from representative coronary procedures procedures enabling our group to Establish scatter radiation reference values based on a large number of representative cath-lab procedures Identify technical and clinical factors predisposing for high staff scatter radiation exposure Evaluate advanced radiation protection devices in clinical routine. This includes: Additional ceiling-suspended lead-shielding Ceiling-suspended radiation protection devices like the Zero-Gravity-System (TIDI Medical Products, Neenah, WI, USA) Patient lead-covers. The study was submitted to and approved by the federal Ethics Committee Salzburg (reference number ECS 1069/2021).

Official Title
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Quantification and Determinants of Occupational Xray Scatter Radiation Exposure of Operators and Assistants During Coronary Procedures - The Occupational SCAtter Radiation Registry

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Scatter radiation exposure measurement


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Scatter radiation exposure measurement|Scatter radiation exposure of the operator and sterile assistant is recorded with digital live dosimeters at 3 locations of the operator (frontal head at eye level, left lateral head, below the left shoulder) and at 2 locations of the sterile assistant (left neck and below the left shoulder)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-procedural Xray scatter radiation exposure (µSv) | Xray scatter radiation dose recorded by 5 personal live dosimeters (3 allocated to the operator, 2 allocated to the sterile assistant). | Duration of procedure |