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临床试验/NCT04389190
NCT04389190Unknown不适用

Radiation Dose Reduction Using Advanced Fluoroscopy Options in Coronary Cath Lab

Tabba Heart Institute2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
480
试验地点
2
主要终点
patient and operator radiation exposure

研究概览

简要总结

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.

详细描述

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

  1. 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.
  2. To assess the effect of low frames per seconds settings in cine imaging and fluoroscopy on quality of image during coronary procedures METHODS

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Intra-cardiac device insertions and procedures requiring digital subtraction angiography (DSA) will be excluded.

结局指标

主要结局

patient and operator radiation exposure

时间窗: 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.

次要结局

  • quality of imaging(within 24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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