Radiation Dose Reduction Using Advanced Fluoroscopy Options in Coronary Cath Lab
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Tabba Heart Institute
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- patient and operator radiation exposure
Study Overview
Brief Summary
Fluoroscopy is integral part of diagnostic and therapeutic cardiac procedures. Among medical personnel, interventional cardiologists have the highest per head per year exposure to ionizing radiation which is two to three times greater than the radiologists. Although the patients' exposure is well below the level associated with increased cancer risk, yet as mentioned above, any exposure can be harmful and must be minimized using all possible dose reduction methods under the principle of 'As Low as Reasonably Achievable' (ALARA).
Radiation exposure is influenced by factors that are dependent on patient (weight, body habitus), procedure (access site, procedure complexity, use of protective shielding, collimation) and equipment (overall quality control, field of view, beam filters thickness, pulse rate etc.). In fact in modern fluoroscopic equipment, several settings are customizable to aid reduce total emitted X-ray dose. In a diverse coronary lab as Tabba Heart institute, in addition to training the lab staff on reducing radiation exposure and use of protective gear, employment of a modern X ray system Like Toshiba (Infinix i8000V, Toshiba America Medical Systems, Inc.); equipped with customizable radiation dose reduction technologies and DTS, provides the interventionists an essential tools to ensure the highest radiation safety standards. Data is still scanty to show the difference in patients and operators' radiation exposures by using tailored equipment settings. We aim to apply customized fluoroscopy protocols based on low fps and other customizable settings (thickness of the spectral beam filters, peak tube voltage and peak cathode current, live zoom (1.4 factors with 12 inch FOV), fluoro store and Spot fluoroscopy) and then assess if they significantly affect the radiation exposure of the patient and the interventionist.
Detailed Description
Fluoroscopy is integral part of diagnostic and therapeutic cardiac procedures. Due to the ionizing effect of X-rays; patients, interventionist and cath lab staff are at risk of radiation hazards that are broadly divided into two categories. One is deterministic; where severity of the injury to the exposed area is dose dependent and there is a safety threshold; the other is stochastic or probabilistic where any radiation dose can cause genetic mutation and cancers and no dose is considered safe. Among medical personnel, interventional cardiologists have the highest per head per year exposure to ionizing radiation which is two to three times greater than the radiologists. Although the patients' exposure is well below the level associated with increased cancer risk, yet as mentioned above, any exposure can be harmful and must be minimized using all possible dose reduction methods under the principle of 'As Low as Reasonably Achievable' (ALARA).
Radiation exposure is influenced by factors that are dependent on patient (weight, body habitus), procedure (access site, procedure complexity, use of protective shielding, collimation) and equipment (overall quality control, field of view, beam filters thickness, pulse rate etc.). In fact in modern fluoroscopic equipment, several settings are customizable to aid reduce total emitted X-ray dose. A lower frame rate of 7.5 frames per second (fps) compared with standard 15fps substantially reduces X-ray exposure (30% relative exposure reduction in operator dose and 19% in patient dose) without compromise in image quality. Using live zoom to digitally enlarge images also lowers the dose by 40-50% (1.4 factors with 6 inch field of view). Another significant advancement is 'Dose Tracking System' (DTS) which calculates the precise radiation dose to the patient's skin and displays the cumulative dose values as a color map on a patient graphic for immediate feedback to the interventionist. This knowledge of the exposure in real time too helps physicians adjust their practices accordingly.
In a diverse coronary lab as Tabba Heart institute, in addition to training the lab staff on reducing radiation exposure and use of protective gear, employment of a modern X ray system Like Toshiba (Infinix i8000V, Toshiba America Medical Systems, Inc.); equipped with customizable radiation dose reduction technologies and DTS, provides the interventionists an essential tools to ensure the highest radiation safety standards. Data is still scanty to show the difference in patients and operators' radiation exposures by using tailored equipment settings. We aim to apply customized fluoroscopy protocols based on low fps and other customizable settings (thickness of the spectral beam filters, peak tube voltage and peak cathode current, live zoom (1.4 factors with 12 inch FOV), fluoro store and Spot fluoroscopy) and then assess if they significantly affect the radiation exposure of the patient and the interventionist.
AIMS/OBJECTIVES
- To compare the effect of three different fluoroscopy protocols on patient and operator's total X ray dose in coronary catheterization lab at Tabba Heart Institute, Karachi.
- To assess the effect of low frames per seconds settings in cine imaging and fluoroscopy on quality of image during coronary procedures METHODS
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •percutaneous coronary interventional (PCI) and other fluoroscopy assisted cardiac procedures including valvular interventions and device closures.
- •Both emergent and elective procedures.
- •Patients undergoing procedures both via trans-radial or trans-femoral approach will be included.
Exclusion Criteria
- •Intra-cardiac device insertions and procedures requiring digital subtraction angiography (DSA) will be excluded.
Arms & Interventions
Standard Protocol
This is the fluoroscopy protocol used routinely in most catheterization labs in the region. This includes fluoroscopy and cine image acquisition at 15 frames per second (FPS) at 8-inch mode. Virtual collimation and last image hold (LIH) will be used as needed. This protocol will be implemented for 6 weeks.
Intervention: Fluoroscopy settings for image acquisition (Other)
Low frame rate protocol
This will have fluoroscopy and cine image acquisition at 7.5 FPS at 8-inch mode with all other settings on factory default. Virtual collimation and LIH will be used as needed. This protocol will be implemented for 6 weeks as well.
Intervention: Fluoroscopy settings for image acquisition (Other)
Customized Protocol
This will have varying settings based on three weight based groups. Small (<60 kg), medium (60-85 kg), large (>85 kg). The variables changed are fluoroscopy dose per frame, fluoroscopy frame rate, image acquisition frame rate, thickness of the spectral beam filters, peak tube voltage and peak cathode current. Additional features will also be utilized including live zoom (1.4 factors with 12 inch field of view, FOV), fluoro store and Spot fluoroscopy. Virtual collimation and LIH will be used as needed. This protocol will be applied for 12 weeks.
Intervention: Fluoroscopy settings for image acquisition (Other)
Outcomes
Primary Outcomes
patient and operator radiation exposure
Time Frame: within 24 hours
Operator dose (μSv): Exposure of X-ray to the first and second operator will be measured using the Raysafe i2 system (Unfors Raysafe, Sweden). The personal dosimeter (PDM) in this consists of semiconductors layered with a film and provides real time dose information. All operators will wear the PDM on left side on upper torso. PDM readings will be obtained on an individual procedure basis and readings will be hidden from the operators. Patient total X-ray dose: This will be calculated by obtaining adjusted mean total x-ray dose i.e. air kerma (Gy), dose area product (DAP) (Gy/cm2) and real time Peak skin dose in mGy using Toshiba Inc.'s dose tracking system.
Secondary Outcomes
- quality of imaging(within 24 hours)