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临床试验/NCT00882297
NCT00882297已完成不适用

Subclavian Vein Ultrasound Guided Cannulation in Adult: Transversal and Longitudinal Approach Comparison

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Time from vein puncture to seldinger guide placement

研究概览

简要总结

There is actually two techniques of subclavian vein ultrasonography-guided venous catheterization : the axial and longitudinal approach. Currently, nothing makes it possible to privilege one technique compared to the other. This study aims to determine the best ultrasonography-guided method.

详细描述

This prospective randomized study will concern 100 adult patients operated of cardiac surgery under general anesthesia and requiring a central venous catheter. Patients will be randomized by an operator experienced in echoguided venous catheterization to be included in the axial (50 patients) or the longitudinal (50 patients) approach group. The device used will be a vascular probe of 7.5 MHz (Sonosite I Look®). The principal outcome measure will be the time from percutaneous puncture to the rise of the metallic guide (seldinger technique). The secondary criteria will be the rate of complication and failure. A series of echographic (size and depth of the subclavian vein and biometric (BMI, theoretical distance not from puncture (way of Aubaniac)/réel) measurements will be done to identify predictive conditions of success or failure depending of the echographic approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

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

  • Patient requiring the installation of a central venous catheter in subclavian site
  • Installation of catheter under general anaesthesia
  • Oral consent of the patient

排除标准

  • Thrombosis in subclavian vein
  • Urgency of central venous catheterization.
  • Insertion of central vein catheter other than subclavian
  • Insertion of subclavian catheter under loco-regional anaesthesia

研究组 & 干预措施

1

Active Comparator

Transversal approach guided placement

干预措施: Echoguided vein puncture (Procedure)

2

Active Comparator

Longitudinal approach guided placement

干预措施: Echoguided vein puncture (Procedure)

结局指标

主要结局

Time from vein puncture to seldinger guide placement

时间窗: After anesthesia during cardiac surgery

次要结局

  • Complications(During cardiac surgery until 48 hours after the end)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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