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临床试验/NCT03812757
NCT03812757已完成不适用

The Supraclavicular Fossa Ultrasound View for Correct Catheter Positioning in Infraclavicular Right Subclavian Central Venous Catheterization

Skane University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Correct catheter tip positioning

研究概览

简要总结

The study will evaluate if the supraclavicular fossa ultrasound view can be used to achieve a correct catheter tip placement in infraclavicular right subclavian central venous catheter placement. This may make routine post-procedural x-ray exams redundant.

详细描述

Central venous catheterization is one of the most common procedures within intensive care medicine. Verification of correct catheter tip placement is a primary aspect of safety and quality of central venous catheterization as malposition may lead to life-threatening complications such as thrombosis, hemothorax, cardiac tamponade, and arrhythmias. Conventional chest x-ray (CXR) is routinely performed after every insertion and is considered gold standard to examine catheter tip location and evaluate for complications such as pneumo- and hemothorax. However, CXR exposes the patient to ionized radiation, requires a considerable amount of time, and is workload-generating for both ICU and radiology staff.

Weber et al has described the use of the right supraclavicular fossa view for real-time ultrasound-guided placement of a central venous catheter (CVC) via the right internal jugular vein (IJV) in adults. This approach has subsequently been validated in a clinical study and has also been used for supraclavicular subclavian line insertion. The approach requires use of a microconvex probe, which couples good image resolution and high scanning depth. The use of a microconvex probe for infraclavicular subclavian central venous catheter (CVC) insertion has been described previously, but this is the first description of the supraclavicular fossa ultrasound view to guide correct catheter tip placement in infraclavicular right subclavian CVC placement.

研究设计

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

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

  • Indication for central venous catheter placement.

排除标准

  • Operator unable to visualize the subclavian vein (e.g., in those with subcutaneous emphysema of the chest wall),
  • Subclavian vein catheterization deemed inappropriate by the operator,
  • Central line/pacemaker/similar device already in place (risk for misinterpretation of the ultrasound image)

结局指标

主要结局

Correct catheter tip positioning

时间窗: Post-procedural x-ray (typically within 24 hours)

Optimal placement (cavoatrial junction, distal superior vena cava); acceptable placement (upper part of the right atrium and entire SVC, provided that the axes of the catheter and vein are aligned to reduce the risk of vessel perforation); unacceptable placement (all other locations).

次要结局

  • Mechanical complications within 24 hours(Within 24 hours after central venous catheterization)

研究者

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

Ola Borgquist

Principal investigator

Skane University Hospital

研究点 (1)

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