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临床试验/NCT05877794
NCT05877794尚未招募不适用

Does the Central Venous Puncture Needle Need to be 7 cm? ; Safety and Usefulness of Needle Length Adjustment Method Using Suture Wing

Ajou University School of Medicine0 个研究点目标入组 20 人开始时间: 2023年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
主要终点
The difficulty of catheterization

研究概览

简要总结

The central venous catheter (CVC) has been used for the first time in clinical use in 1921 and has been used worldwide by 2023. Although there are differences between studies, it is reported that side effects occur in approximately 5-20% of patients undergoing CVC. Common side effects include hematoma, venous puncture, arterial puncture, and pneumothorax, and horner syndrome is also reported in 5% of cases. In particular, in the case of the internal jugular vein (IJV), the possibility of puncture of the internal carotid artery is higher than that of other sites, and the puncture level also varies depending on the depth of needle insertion, which in some cases can cause very serious side effects. The incidence rate of side effects depends on the method of inserting the CVC and the skill of the operator. Previous method approached the IJV using the anatomy ladmark with the blind Seldinger technique, recently, as the use of ultrasound has become more common.

Ultra sound guided CVC insertion tecnique reduce the incidence of side effect. However, there are still major complications exist because less experiance operator inserts needle too deep without caution and only depends on the image of sonography.

Currently, the length of the needle commonly used in the CVC catheter set is 7 cm. In general, the depth from the skin to the IJV is within 1.5cm on either the right or the left, and under the premise that the needle insertion angle is 45 degrees, the distance from the skin to the IJV is within 2cm. Based on this, in previous studies, it was announced that the length of the needle required for IJV access was less than 4 cm.

The purpose of this study is to study the usefulness and safety of the method of sono-guided CVC catheter insertion by fixing the needle at a position 4 cm from the needle tip by placing the suture wing (18G, single catheter set).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who need CVC catheter for operation

排除标准

  • Obesity (BMI > 35)
  • wound or infection exist at the puncture site
  • History of long term catheter placment in the IJV
  • Abnormally small size or deformity of the IJV
  • Past history of difiiculty in CVC catheterization
  • If the IJV is located at a depth of 3cm or more from theskin on ultrasound evaluation

结局指标

主要结局

The difficulty of catheterization

时间窗: through study completion, an average of 10 minutes

It would be evaluated by the operator who performed the catheterization. The severity of difficulty would be determined by total sum of the following scores. 1. needle tip visibility with sono: good (0), not good (1), bad(2) 2. blood aspiration was during needle withdrawal :1 3. Number of attempt :1 ,2, 3 Total score would be ranged from 0 to 6

次要结局

未报告次要终点

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jiyoung Yoo

associate professor

Ajou University School of Medicine

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