Comparison of Ultrasound guided umbilical insertion with conventional method- A randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- To compare the failure rates of usg guided umbilical venous catheter (UVC)insertion with the conventional method
研究概览
简要总结
This study is a open label randomized parallel group trial comparing ultrasound guided umbilical venous catheter insertion with conventional(blind) insertion. Trial will be conducted in preterm/term neonates who are admitted in NICU and require prolonged intravascular access. The primary outcome is to compare the failure rates of Ultrasound guided UVC insertion with the conventional method. The secondary outcomes are comparison of tip position of UVC with X-ray, to observe the complications with UVC insertion and to calculate the time difference between ultrasound and X-ray for completion of the procedure. Analysis will be done at the end of 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •All terms/preterm with prolonged intravascular access for the following conditions
- •Babies on mechanical ventilation for respiratory failure, mechanical asphyxia
- •Total parenteral nutrition
- •Shock 4.hypoglycemia with GIR>12.5% 5.IV fluids for surgical indications.
排除标准
- •1.Congenital anomalies of abdominal wall
- •Necrotizing enterocolitis
- •Peritonitis.
结局指标
主要结局
To compare the failure rates of usg guided umbilical venous catheter (UVC)insertion with the conventional method
时间窗: Reduction in failure rate assessed after18 months
次要结局
- To calculate the time taken for USG and calculate the time difference between USG and radiograph(18 months)
- To compare USG with X-ray in determining the tip position of UVC(18 months)
- To observ complications with UVC insertion(18 months)