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临床试验/CTRI/2023/03/050673
CTRI/2023/03/050673尚未招募不适用

Comparison of accuracy of ultrasound guided umbilical venous catheter insertion with standard technique in neonates admitted in neonatal intensive care unit - a randomised controlled trial

FLUID RESEARCH GRANT1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2023年3月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
112
试验地点
1
主要终点
Rate of accurate positioning of umbilical venous catheter tip in ultrasound guided group compared with standard group

研究概览

简要总结

Umbilical venous catheters provide unique and easy central venous access in neonates. They are usually inserted based on a pre calculated depth of insertion. There are various methods to determine the depth of insertion. The position is confirmed with a radiograph. A common problem encountered with umbilical catheter insertion is catheter malposition. Malpositioned catheters are associated with various complications and warrant removal or repositioning. In current practice, with the increasing availability of point of care ultrasound, it is also being used to localize catheter tips. In this study, we are evaluating an ultrasound-guided technique to prevent catheter malposition, specifically portal vein cannulation. We propose to compare the accuracy of ultrasound-guided catheter insertion versus standard  procedure. In this technique, UV catheter is inserted under ultrasound guidance. As the catheter is being inserted, the tip will be localized with an ultrasound probe kept over the abdomen. At the level of portal sinus, if the catheter is advancing to the portal vein, instead of ductus venosus, pressure will be applied over the abdomen with the ultrasound probe. This makes a change in the alignment of the venous system that the portal vein gets occluded and ductus venosus comes in line with the sinus, thus guiding the catheter into ductus venosus and then IVC.

We also propose to look at the time taken for catheter insertion and incidence of central line associated blood stream infection and extravasation associated with both techniques. This study may help in developing a bedside technique to accurately insert UVC, thus minimizing chance of catheter malposition.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Outcome Assessor Blinded

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Neonates requiring umbilical venous catheter insertion as a part of their NICU care.

排除标准

  • Suspected or diagnosed congenital diaphragmatic hernia Suspected or diagnosed heterodoxy syndromes or situs inversus hydrops foetalis Babies requiring umbilical venous catheter insertion in labour room or operation theatre Persistent pulmonary hypertension of newborn.

结局指标

主要结局

Rate of accurate positioning of umbilical venous catheter tip in ultrasound guided group compared with standard group

时间窗: Within 3 hours after catheter insertion

次要结局

  • Incidence of extravasation(Till the catheter is removed)
  • Time taken for catheter insertion(At the time of catheter insertion)
  • Incidence of central line associated blood stream infection(Till the catheter is removed)

研究者

发起方
FLUID RESEARCH GRANT
申办方类型
Private medical college

研究点 (1)

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