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临床试验/NCT03426735
NCT03426735已完成不适用

Multicenter Study to Evaluate the Effectiveness of Dry Heat in the Extravasations of Iodinated Contrast.

Hospital de Sant Pau18 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2017年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
18
主要终点
Time resolution the swelling and pain.

研究概览

简要总结

The purpose of this study is to determine the best intervention after the extravasation of the iodinated contrast medium out of a vessel into the surrounding tissues.

详细描述

The risk of intravenous extravasation of iodinated contrast media has a relatively low incidence, although the increase in requests for computed tomography scans where it can manage contrasts with a large volume, high osmolality, high-speed injection pumps and even with an added electrical load, has caused an increase in this risk and its complications.

When there is an extravasation of iodinated contrast medium, in most published recommendations and guidelines advise local conservative measures, but there is no consensus on whether cold or heat should be applied as the first intervention to minimize the consequences and favour a rapid resolution.

This study aims to evaluate the effectiveness of the application of heat in the extravasations of iodinated contrast, providing the necessary evidence to determine the best cure that can be applied in the current circumstances of administration, by injection pumps at high speeds and large volumes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Computed tomography procedure.
  • Administration of the contrast medium with injection pump between 1,5 and 8 ml/s.
  • Peripheral venous access in the arms or legs.

排除标准

  • Administration of the contrast medium with central venous access.
  • Renal insufficiency.
  • Iodine allergy.
  • Immediate acute complications.

结局指标

主要结局

Time resolution the swelling and pain.

时间窗: 24-48 hours past

次要结局

未报告次要终点

研究者

发起方
Hospital de Sant Pau
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaume Roca Sarsanedas

Radiology Nurse

Hospital de Sant Pau

研究点 (18)

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