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

  • STATUS
    Recruiting
  • End date
    Jun 8, 2023
  • participants needed
    750
  • sponsor
    Paracelsus Medical University
Updated on 9 July 2021
angiography

Summary

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:

  1. to establish scatter radiation reference values based on a large number of representative cath-lab procedures
  2. to identify technical and clinical factors predisposing for high scatter radiation exposure,
  3. to evaluate advanced radiation protection devices in clinical routine.

Description

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

  1. Establish scatter radiation reference values based on a large number of representative cath-lab procedures
  2. Identify technical and clinical factors predisposing for high staff scatter radiation exposure
  3. 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).

Details
Condition Coronary Artery Disease, Coronary heart disease, Cardiac Ischemia, Myocardial Ischemia
Treatment Scatter radiation exposure measurement
Clinical Study IdentifierNCT04945538
SponsorParacelsus Medical University
Last Modified on9 July 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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