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临床试验/NCT02483507
NCT02483507已完成不适用

Ultrasound-guided Peripheral Vascular Access: What Approaches in Paediatrics?

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2014年5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
入组人数
300
试验地点
1
主要终点
Success rate

研究概览

简要总结

Landmarks used to make a vascular puncture has long been based on the only knowledge of anatomy. This method assumes that the target vessel is in its expected position, permeable (non-thrombosed), and heavy enough to be catheterized. Any variations from these assumptions is likely to cause failures of puncture and complications. The development of ultrasound allowed to "see" the structures to achieve, whether before a puncture or in live for guiding the procedure. Visualization of vessels and adjacent structures has logically resulted in larger cases to a greater security of catheterization, improving the success rate, and decreasing complications. Several positions of the probe can be used to guide a puncture under ultrasound: the transversal approach in short axis, the long axis longitudinal approach and the oblique view approach.The aim of the study was to compare these three different ultrasound-guided approaches to peripheral vascular access in children. All children weighing less than 30 kg that should benefit from the introduction of an arterial catheter or central venous catheter introduced through a peripheral vein are eligible. Patients will be included after parent's and children's information and consent. The choice of the technique used (transverse, longitudinal or oblique approach) is determined by a randomization table.The puncture procedure is performed according to the usual protocols of the paediatric anesthesia unit of the investigators, under ultrasound guidance in a sterile manner. No time limit is required for the identification and implementation of the catheter. The position of the probe is dictated by the result of randomization and the Seldinger technique is used for the establishment of the catheter. Beyond two unsuccessful attempts, the procedure is considered as a failure. The anesthetist then uses the alternative technique of his choice. All anesthetists participating in this study exercised their main activity in the Montpellier University Hospital pediatric anesthesia unit. The laying of ultrasound-guided peripherally inserted central catheter and arterial catheter is part of the current activity of the unit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Child requiring the implementation of a peripherally inserted central catheter or an arterial catheter.
  • •Child whose general state corresponds to the Physical status score I - IV
  • •Child whose weight is lower to 30 kg
  • •Child whose parents will have given their informed consent.
  • •Child affiliated to a national insurance scheme

排除标准

  • •Child presenting a contraindication to the general anesthesia
  • •Child whose weight is upper to 30 kg
  • •Child whose parents did not give their informed consent

研究组 & 干预措施

Group T: transversal

Active Comparator

Implementation of the vascular catheter with transversal approach under ultrasound guidance

干预措施: Ultrasound-guided approach to peripheral vascular access (Other)

Group L: longitudinal

Active Comparator

Implementation of the vascular catheter with longitudinal approach under ultrasound guidance

干预措施: Ultrasound-guided approach to peripheral vascular access (Other)

Group O: oblique

Active Comparator

Implementation of the vascular catheter with oblique approach under ultrasound guidance

干预措施: Ultrasound-guided approach to peripheral vascular access (Other)

结局指标

主要结局

Success rate

时间窗: one hour

The success of the procedure is defined by the success of the puncture to the first or the second attempt.

次要结局

  • The number of attempts(one hour)
  • The duration of the puncture procedure(on hour)
  • The operator satisfaction(one hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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