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临床试验/NCT06644885
NCT06644885尚未招募不适用

Complications of the Cephalic Route in Implantable Site Placement in Children

University Hospital, Angers0 个研究点目标入组 426 人开始时间: 2024年12月15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
426
主要终点
Characteristics of the study group

研究概览

简要总结

Totally implantable venous access devices (TIVADs) offer long-term central venous access for children requiring intravenous treatments. Their use is recommended in infants (31 days - 1 year old) for >31 days of non-peripherally compatible therapy, and in children and adolescents (>1 year old) for any intravenous therapy lasting more than 31 days. Indications include chemotherapy administration and chronic disease management, avoiding repeated peripheral venous punctures and causing less interference with the activities of the patients.

There are several methods for TIVAD placement, but the optimal evidence-based method remains unclear . The two main approaches for TIVAD placement are closed cannulation of a vein, followed by insertion of the catheter in Seldinger technique, and the surgical insertion of the catheter into a vein through an open cut-down technique 5-7. Different location of insertion are possible: by closed cannulation, the catheter is usually placed in subclavian vein, internal jugular vein, and brachiocephalic vein; by open cut-down it can be placed in external jugular vein, axillary vein, or cephalic vein.

Thanks to progress in medical and surgical care, children are nowadays surviving previously fatal illnesses, but with the need of long-term treatments. For this reason, it's essential to preserve their vessel health. With this objective, in the CHU of Angers, physicians prefer trying first the cephalic vein cutdown for TIVAD positioning in children, reserving the use of other venous accesses in case of failure of this procedure or the need for multiple devices implantations.

To date, few reports have been published about cephalic vein cutdown in children. It is a common opinion that this technique can't be successfully performed in patients under a certain limit of weight or age. In this context, the investigators conducted a retrospective single-centre study to analyse the results of cephalic vein cutdown in children. The primary aim was to describe the feasibility of this technique in paediatric population and identify the risks factors associated with its failure. In addition, this study describes indications, outcomes, and complications of TIVAD implantation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • All patients under 18 years who underwent TIVAD implantation between 2012 and
  • Patients for whom cephalic vein cutdown was the first attempted surgical technique for device placement.

排除标准

  • Patients who previously had a central venous access

结局指标

主要结局

Characteristics of the study group

时间窗: 1 year

Risk factors for cephalic vein cutdown failure for TIVAD positioning

次要结局

  • cephalic vein cutdown(1 year)
  • Post-operative complications(1 year)
  • TIVAD removal(1 year)

研究者

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

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