跳至主要内容
临床试验/NCT01919528
NCT01919528已完成不适用

Real-time Ultrasound-guided Catheterization of the Axillary Vein in the Intensive Care Unit

Uniwersytecki Szpital Kliniczny w Opolu2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2012年12月1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
202
试验地点
2
主要终点
to define venipuncture, catheterization and entire procedure success rates

研究概览

简要总结

The central venous catheterization (central line placement) is the common procedure performed in the intensive care unit. This procedure is performed by percutaneous puncture of so called 'the central vein' and than advancement of the catheter over the guidewire (Seldinger technique). The tip of the catheter is left in the superior vena cava in the vicinity of the right atrium of the heart. Central veins are large veins in the human body passing the blood into the heart.

Typical, clinical indications for the central line placement in the intensive care unit are hemodynamic monitoring, volume monitoring, administration of medications, long-term total parenteral nutrition, access for renal replacement therapy, difficult peripheral catheterization.

There are two methods of the central venous catheterization in terms of visualization. First and older is the blind technique. The operator is locating the anatomical landmarks and then performing the entire procedure blindly by percutaneous puncture. This is called the landmark technique. Second and new is the ultrasound-guided technique. The operator is locating the vein using ultrasonography and then performing the entire procedure under ultrasonographic visualization. The real time ultrasound-guided central venous catheterization became the standard of care in recent years mainly because of safety issues (is regarded as safer than landmark technique)

The catheterization of the axillary vein is not popular procedure in daily clinical practice. But it can be reasonable and safe alternative to others, typically performed central venous catheterizations like the internal jugular vein and the subclavian vein catheterizations.

The main intention of this study is to assess usefulness and safety of the real time ultrasound guided axillary vein catheterization in mechanically ventilated patients admitted to the intensive care unit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • mechanically ventilated intensive care patients with clinical indications for central venous line placement

排除标准

  • trauma and hematoma at the catheterization site
  • history of multiple central venous catheterizations (three or more)
  • chest wall deformities
  • major blood coagulation disorders
  • history of thoracic surgery
  • anatomical abnormalities at the catheterization site
  • infection at the catheterization site
  • age less than 18 years
  • lack of patients or closest relatives consent

结局指标

主要结局

to define venipuncture, catheterization and entire procedure success rates

时间窗: 24 hours

the venipuncture is defined as perforation of the axillary vein by the needle, the catheterization is defined as the placement of catheter in the final position, the entire procedure success rate is defined as the placement of catheter in the final position without early complications (assessed within 24 hours time frame)

to assess the erly complication rate of ultrasound-guided axillary vein catheterization

时间窗: 24 hours

pneumothorax, puncture of the axillary artery, hemothorax, heart perforation, catheter malposition, significant arrhythmias, air embolism

次要结局

  • to assess the correlation between entire procedure success rate and the side of catheterization(2 years)
  • to assess the correlation between patients weight, height and depth, diameter of the axillary vein(2 years)

研究者

发起方
Uniwersytecki Szpital Kliniczny w Opolu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomasz Czarnik, MD PhD

senior anesthesiologist

Uniwersytecki Szpital Kliniczny w Opolu

研究点 (2)

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