Safety and efficacy of Open vs Ultrasound guided tunnelled central venous access in children- A randomised controlled trial
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 109
研究概览
简要总结
The study compared two techniques of insertion of central venous lines in children. The traditional open surgery exposure of vein was compared to ultrasound guided insertion using a needle to access the vein. The study aimed to identify which of the two techniques was associated with lesser complications and preserved the vein calibre in long term. All children under 16 referred to the surgical service for central vein access for the first time were eligible to participate. Children were randomised to one of the groups. Complications during insertion, during course of treatment related to the lines were noted. Vein size was noted at time of insertion and at removal. Results of the study showed that the ultrasound guided technique was safer, quicker and preserved vein size in the long term. The study was limited by smaller than expected numbers recruited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 1 Days 至 16 Years（—）
- 性别
- All
入选标准
- •All children >0 to 16 years referred for insertion of Hickman’s or Implantable vascular access device for total parenteral nutrition, chemotherapy or replacement therapy will be included in the study. The study will be performed at The Children’s Hospital at Westmead. Ultrasound guided access will be the study group compared to the control group of open cut down insertion
排除标准
- •1.Patients with loss of both internal jugular veins from prior catheter insertion will be excluded.
- •2. Children with vascular access into veins other than internal jugular vein.