Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Subclavian Venous Catheterization: Seldinger vs. Modified Seldinger Technique
试验速览
- 阶段
- 不适用
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- Major complication rate of subclavian catheterization
研究概览
简要总结
Seldinger technique is a minimally invasive technique in which the practitioner accesses the target vessel with a small bore needle, then dilates to the size required for the catheter. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath.
Both technique is widely used in central venous catheterization, however, few researches have been investigated to compare success rate or complications of both methods.
详细描述
The major complications of central venous catheterization through subclavian vein, are unintended arterial puncture, pneumothorax, hemothorax, malposition of catheter etc,. We assume that using modified Seldinger technique (MST), guiding sheath is easily slid over the needle, providing stable route into the vessel lumen relatively.
We aimed to compare the Seldinger technique and modified Seldinger technique(MST) on success rate and complications during subclavian central venous catheterization in this prospective, randomized , controlled trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient scheduled for surgery under genearl anesthesia and subclavian vein central catheterization
排除标准
- •Patient who does not agree to the study
- •Inflammation or infection on catheterization site
- •Contralateral diaphragmatic dysfunction
- •Anatomic anomalies of subclavian artery or vein/clavicle
- •Previous lung surgical history
- •Patient who has ventriculoperitoneal shunt or chemoport on same side
- •Patient who has pneumo/hemothorax or lung parenchymal disease
研究组 & 干预措施
GroupC
Group C means Control group which use Seldinger technique for subclavian catheterization. The aimed vessel(subclavian vein) is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and the needle is removed. After that catheter is passed over the guidewire into the vessel.
干预措施: Seldinger technique (Procedure)
Group MS
Group MS means experimental group which use modified Seldinger technique for subclavian catheterization. The aimed vessel is punctured with the needle that is covered with guiding sheath. After vessel is punctured, guiding sheath is instatntly slid over the needle into the vessel. The needle is removed, guidewire is advanced through the sheath, central catheter is placed into the vessel.
干预措施: Modified Seldinger technique (Procedure)
结局指标
主要结局
Major complication rate of subclavian catheterization
时间窗: intraoperative
Compare main complication rates of subclavian catheterization including pnumothorax, hemothorax, arterial puncture, malposition of cathter.
次要结局
- Total insertion time(From skin puctuation until confim the successful catheterization anticipated within 3min)
- primary success rate of subclavian catheterization(intraoperative)
研究者
Hee-Pyoung Park
Professor
Seoul National University Hospital