跳至主要内容
临床试验/CTRI/2024/05/066784
CTRI/2024/05/066784尚未招募不适用

Efficacy of the RADPAD Protection Drape in Reducing Operators’ Radiation Exposure in biliary interventions :A Randomized controlled Trial

未提供1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年5月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
48
试验地点
1
主要终点
Dose reduction in operator during biliary interventions.

研究概览

简要总结

Even though technology has advanced, exposure to low-dose radiation is an indispensable aspect for an interventional radiologist. The radiation dose that the operator receives varies greatly from procedure to procedure and is influenced by the level of experience, the radiation equipment, the type of surgery, and the patient’s characteristics. An increase in the number and intricacies of procedures causes a further rise in the operator’s being subjected to scatter radiation in the catheterization lab.

Exposure to radiation can cause deterministic and stochastic effects. A case series of interventional cardiologists with left-sided brain tumours raises the pertinent issue newer and better safety precautions to safeguard operators.

The RADPAD (RADPAD 5100A-O; Worldwide Innovations & Technologies, Inc, Lenexa, KS) is a sterile, disposable, lead-free shield that acts as a barrier between the image intensifier and the operator to reduce operator received scatter radiation . No previous studies are available on biliary interventions. The primary aim of the study is to examine the effect of a RADPAD on the operator’s radiation dose, during biliary interventions in a randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 1.Moderate and gross dilated IHBRD 2.Cholangitis/hyperbilirubinemia for biliary drainage 3.Left sided PTBD.

排除标准

  • 1.Ascites 2.Deranged coagulation profile.

结局指标

主要结局

Dose reduction in operator during biliary interventions.

时间窗: during procedure

次要结局

  • dose reduction in patients(during procedure)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Tara Prasad Tripathy

AIIMS bhubaneswar

研究点 (1)

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