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临床试验/NCT01902355
NCT01902355已完成不适用

Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Central Venous Catheterization: Seldinger vs. Modified Seldinger Technique

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 272 人开始时间: 2013年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
272
试验地点
2
主要终点
number of attempts of guidewire advance

研究概览

简要总结

The purpose of this study is to compare two needle insertion techniques(Seldinger vs. modified Seldinger technique) on success rate and complications during central venous catheterization.

详细描述

Unintended arterial puncture and local hematoma formation are the most common complications during internal jugular vein central venous catheterization. Other serious complications like pseudoaneurysm, arteriovenous fistula, arterial dissection, thrombosis, embolism are also possible. These complications mostly occur by mechanical trauma or injury when advancing needle back and forth to puncture internal jugular vein. Placement of guidewire or dilator can also cause mechanical trauma or injury around the vessel.

Because internal jugular vein collapses easily during needle advance, anterior and posterior wall of the vessel can be punctured simultaneously. Posterior wall puncture can increase the risk of complications of the catheterization. Delicate puncture of the vessel and stable fixation of the needle after puncture are important to reduce overall number of catheterization attempts, increase success rate, reduce complications.

Seldinger technique(thin-wall needle technique) is commonly used procedure to obtain safe access to central vein. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel.

When using Seldinger technique, it is important to fix the needle firmly with hand until the guidewire is placed into the vessel lumen. If hand fixation is not stable, needle tip can migrate from the lumen, can pierce the vessel wall, and carotid artery puncture, and local hematoma formation might occur. Even if there is no evidence of complications, when blood regurgitation fails, overall number of vessel puncture attempts would increase and it is expected that rate of complications of the catheterization would increase.

When using modified Seldinger technique, guiding sheath is easily slid over the needle, providing stable route into the vessel lumen relatively in early step of the catheterization. Therefore, it is expected that stability of the fixation improves, success rate of the catheterization increase, and complications of the catheterization decrease. But there is no high level of evidence yet, and still decision to use which technique is based on experience of the operator.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient scheduled for surgery and internal jugular vein central catheterization

排除标准

  • Patient who doesn't agree to the study
  • Catheterization site inflammation
  • Contralateral diaphragmatic dysfunction
  • Anatomic anomalies of carotid artery or vein
  • Previous neck surgical history
  • Recent(less than 1 month) right internal jugular vein central catheterization

研究组 & 干预措施

modified Seldinger technique

Experimental

Use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel.

干预措施: modified Seldinger technique (Procedure)

Seldinger technique

Active Comparator

The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel.

干预措施: Seldinger technique (Procedure)

结局指标

主要结局

number of attempts of guidewire advance

时间窗: after internal jugular vein puncture

after desired vessel is punctured guidewire is advanced through the lumen of the needle or guiding sheath

次要结局

  • complications of internal jugular vein central catheterization(after central catheter placement)

研究者

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

Deok Man Hong

Assistant Professor

Seoul National University Hospital

研究点 (2)

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