Ultrasound guided umbilical venous catheter insertion to reduce rate of catheter tip malposition in neonates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary objective is the reduction in the catheter tip malposition rates when catheter insertion done ultrasound guidance in neonates admitted in NICU. Optimal position on radiograph is defined when it is placed between T8 and T10 on radiograph and on USG where the catheter tip is in the IVC between the hepatic veins confluence and right atrium opening. A vertebral landmark of T8 to T10 corresponds to the vena cava right atrial junction in 90 percent of the neonates
研究概览
简要总结
This study is an open, randomised, parallel group, single centre trial with aim to compare whether umbilical venous catheter insertion under ultrasound guidance reduces rate of catheter tip malposition rates compared to standard insertion followed by radiograph in neonates admitted in NICU. Primary objective is reduction in catheter tip malposition rates when catheter insertion done by ultrasound guidance in neonates admitted in NICU. In the secondary objectives we will also see if it leads to reduction in number of catheter tip repositioning required, time taken to insert catheter in both groups, to compare accuracy of ultrasound compared to radiograph in determining catheter tip position. Catheter tip if malpositioned will be noted and any effect of weight on rate of malposition will also be noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Day(s) 至 7.00 Day(s)（—）
- 性别
- All
入选标准
- •All neonates admitted in NICU requiring umbilical venous catheter insertion within 1st week of life will be included.
排除标准
- •Major congenital anomalies of thorax and abdomen.
结局指标
主要结局
The primary objective is the reduction in the catheter tip malposition rates when catheter insertion done ultrasound guidance in neonates admitted in NICU. Optimal position on radiograph is defined when it is placed between T8 and T10 on radiograph and on USG where the catheter tip is in the IVC between the hepatic veins confluence and right atrium opening. A vertebral landmark of T8 to T10 corresponds to the vena cava right atrial junction in 90 percent of the neonates
时间窗: Immediate
次要结局
- Position of catheter tip when malpositioned in both groups(Immediate)
- Reduction in number of catheter repositioning required(Immediate)
- To compare accuracy of ultrasound with radiograph (current gold standard) in determining catheter tip position.(Immediate)
- Time taken for the completion of procedure in both groups(Immediate)
- Role of catheter insertion by manoeuvre of aligning the umbilical vein and ductus venosus as described by Kishigami et al(Immediate)
- Rate of malposition in groups stratified according to weight(Immediate)