跳至主要内容
临床试验/NCT02895711
NCT02895711已完成不适用

Radiation Doses of Pediatric Patients During Ureteroscopy and Percutaneous Nephrolithotomy

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
Exposed to fluoroscopic radiation

研究概览

简要总结

The purpose of this study is to quantify the radiation exposure from diagnostic testing and surgical treatment during routine endourologic procedures for symptomatic urolithiasis.

详细描述

Routine endourologic procedures will be performed at the Childrens Hospital of Pittsburgh by one of the investigators listed on this study. Fluoroscopic radiation exposure during these procedures is used to guide the surgical devices that are used to treat the stones. The investigators will be measuring the radiation effective skin dose by two methods. First, the investigators will place two "Microdot" thermal leak detectors (TLD) on the patient. These devices which are the size and thickness of a dime will be within plastic bags taped to the patients body within the central focus of the fluoroscopy image. At the completion of the procedure the TLD's will be transferred to the Radiation Safety Office in Oakland to be read and the dose recorded.

Second, a flat chamber that is integral with all fluoroscopy machines used at Children's Hospital will measure the dose-area product (DAP) for each case which will allow us to calculate the effective dose. This device is a component of the colimeter on the arm of the x-ray machine used for fluoroscopy. It measures the radiation that is returned to the x-ray machine and calculates the dose delivered to the patient by comparing the amount delivered to the patient to the amount returned to the machine. Its use is automatic when any x-rays are delivered and does not involve any manipulation of the patient or alteration of normal procedure.

No additional procedures or change in duration is necessary for this study

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Eligible subjects will be male and female volunteers of 0-18 years of age with documented urolithiasis who is undergoing a urologic procedure that utilizes fluoroscopy radiation.
  • The racial, gender and ethnic characteristics of the proposed subject population reflect the demographics of Pittsburgh and the surrounding area and/or the population of the University of Pittsburgh.
  • We shall attempt to recruit subjects in respective proportion to these demographics.

排除标准

  • 未提供

结局指标

主要结局

Exposed to fluoroscopic radiation

时间窗: through study completion, an average of 1 year

To record the effective radiation dose to the patient during endourologic procedures to treat urolithiasis

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

Rajeev Chaudhry

Assistant Professor

University of Pittsburgh

研究点 (1)

Loading locations...

相似试验

Radiation Dose of Pediatric Patients During... | 临床试验