跳至主要内容
临床试验/NCT06931171
NCT06931171招募中不适用

Zero-cost Radiation Protection Method to Reduce Radiation Exposure of Interventional Cardiologists During Transradial Percutaneous Coronary Procedures (FREEPADRAD Trial)

National and Kapodistrian University of Athens2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年1月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
2
主要终点
Effectiveness of Patient-Applied Pelvic Shielding in Reducing Operator Radiation Exposure During Transradial Coronary Procedures

研究概览

简要总结

Ionising radiation is a recognised occupational hazard in interventional cardiology. This prospective, randomised trial aims to evaluate the effectiveness of additional radiation protection by existing devices but with a different use, specifically the use of medical lead aprons (designed and used to be worn by the medical and nursing staff for radiation protection) covering the patient's lower abdominal and pelvic area during transradial coronary angiography and angioplasty. The intervention's efficacy will be assessed by measuring the reduction in operator radiation exposure and determining the impact of various clinical and procedural factors.

详细描述

Ionizing radiation refers to any type of radiation capable of interacting with matter. It plays a vital role in medical diagnostics and therapeutic applications. Imaging techniques allow for timely and accurate diagnosis, while advanced therapies contribute to longer life expectancy and improved quality of life. However, ionizing radiation carries inherent risks, making its controlled use essential. Radiation exposure is not immediately perceptible but can result in significant damage to the exposed organism. Common effects of high-dose exposure include ocular damage and skin injuries, while radiation is also associated with cellular-level damage, leading to an increased risk of malignancies. Exposure is proportional to time, inversely proportional to the square of the distance from the source, and accumulates over time.

Despite technological advancements and improved X-ray systems, the increasing complexity and frequency of interventional cardiology procedures have led to higher radiation exposure in catheterization laboratories. This poses a major occupational hazard for medical staff, highlighting the need for effective methods to reduce radiation exposure and protect healthcare professionals. Operator radiation exposure varies depending on experience, procedure type, patient characteristics, X-ray system features, and protective measures used. These measures include disposable gloves, shields, lead aprons, and robotic systems.

This prospective, randomised trial evaluates the efficacy of a cost-effective (namely zero-cost) and very easily utilised radiation protection strategy for interventional cardiologists during transradial coronary procedures. By applying a triple-layer lead apron to the patient's pelvic region, the study aims to reduce operator radiation exposure while maintaining standard procedural outcomes. The randomized controlled trial will compare the intervention group utilizing the additional shielding with a control group employing standard radiation protection methods. Key measurements include direct operator radiation exposure and its relation to patient-specific and procedural factors. Findings may establish a practical method for reducing the specific radiation-related occupational hazard related to modern transracial interventional cardiology.

研究设计

研究类型
Interventional
分配方式
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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing transradial diagnostic coronary angiography or angioplasty.
  • •Adults aged 18 years and older.
  • •Informed consent provided.

排除标准

  • •Acute STEMI requiring primary percutaneous coronary intervention (PCI).
  • •Patients undergoing structural heart interventions.
  • •Initially femoral access or crossover to femoral access procedures.
  • •Patients unable to provide informed consent.

研究组 & 干预措施

Use of conventional radiation protection measures.

No Intervention

This group will undergo transradial coronary procedures using only conventional radiation protection measures. These include standard operator lead aprons, fixed protective drapes, and other standard shielding equipment typically employed in the catheterization laboratory. No additional radiation protection devices or techniques will be applied to the patient. This arm serves as the baseline for comparison with the intervention group.

Additional patient-applied pelvic lead shielding

Experimental

This group will undergo transradial coronary procedures with the addition of a patient-applied pelvic lead shield. Alongside the conventional radiation protection measures used in the control group, a triple-layer lead apron will be placed over the patient's lower abdominal and pelvic region. This shield, composed of three 0.25 mm Pb-equivalent layers, is designed to reduce scatter radiation exposure to the operator. The intervention aims to assess the effectiveness of this additional protective measure in reducing operator radiation dose.

干预措施: Patient-Applied Pelvic Lead Shielding (Radiation)

结局指标

主要结局

Effectiveness of Patient-Applied Pelvic Shielding in Reducing Operator Radiation Exposure During Transradial Coronary Procedures

时间窗: During the transradial coronary procedure, measured from the start to the completion of fluoroscopy.

Primary Outcomes: Absolute Operator Radiation Exposure: Direct measurement of operator exposure (µSv) using a dosimeter placed outside the lead apron at chest level.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Georgios Latsios

Director of Cardiology, Principal Investigator, Interventional Cardiologist

National and Kapodistrian University of Athens

研究点 (2)

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