UGIST Pilot Trial: Ultrasound Guided Internal Jugular Short-Term Central Venous Catheters Tunneling. Does it Reduce the Technical Difficulty and Mechanical Complications?
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reduction in Technical difficulty
研究概览
简要总结
The purpose of the study is to determine if tunneling standard short-term central lines for a short distance under the skin, with the assistance of ultrasound imaging, reduces the risk of central line infections for catheters placed in the neck vein.
Previous work has shown that these lines can be tunneled without ultrasound guidance. We wish to determine if the use of ultrasound makes the tunneling procedure safer and easier.
详细描述
More than 250,000 vascular catheter-related bloodstream infections occur annually in the USA with a mortality ranging from 12% to 25% in critically ill patients.
It is also widely accepted that the internal jugular site is associated with a higher risk of catheter related infection if compared with the subclavian site.
Therefore, the benefit of catheter tunneling was best seen at the internal jugular site as described by J F Timsit in 1996 in his prospective randomized multicentre study where it significantly decreased the rate of catheter related sepsis from 11.4% to 3.4%.
At the same time, tunneling catheters did not increase the rate of mechanical complications such as pneumothorax, hematoma, or arterial puncture, but it almost doubled the rate of technical difficulties, such as problems with advancing the catheter or multiple puncture sites, at that time it was a blind technique.
Now, and with the introduction of the ultrasound guidance in our routine central line insertions, we would like to evaluate its benefit in reducing the technical difficulty and mechanical complications that used to be encountered while tunneling the short term central venous catheters at the internal jugular site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ICU patients.
- •Likely to need the line for 48 hours.
- •Standard central venous catheter.
排除标准
- •Mechanical impedance (e.g C-spine protection).
- •Absent Internal jugular vessel on U/S.
- •Previous line still in place.
- •Presence of overlying skin or tissue infection or mass.
- •Tricuspid valve vegetation.
- •Tumor extending to the right atrium.
- •Persistent coagulopathy.
- •Newly inserted Pacemaker leads.
- •Recent carotid endarterectomy on same side.
- •No ultrasound facility available.
- •Patients requiring special lines (e.g. Dialysis).
结局指标
主要结局
Reduction in Technical difficulty
时间窗: 6-8 weeks for the whole 20 pts.
次要结局
- Signs of line related blood stream infection/bacteremia.(6-8 weeks for all 20 pts.)