跳至主要内容
临床试验/NCT07434102
NCT07434102已完成不适用

Umbilical-Ductus Venosus Angle: A Novel Ultrasound Tool for Predicting Optimal Umbilical Venous Catheter Placement

Princess Anna Mazowiecka Hospital, Warsaw, Poland2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年9月22日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
78
试验地点
2
主要终点
Umbilical Venous-Ductus Venosus Angle

研究概览

简要总结

The goal of this clinical trial is to learn if the ultrasound assessment of the angle formed between the terminal segment of the Umbilical Venous and the initial segment of the Ductus Venosus (DV)play a role in Umbilical Venous Catheterization (UVC). The main questions it aims to answer are:

Can the Umbilical Venous-Ductus Venosus angle on Point-of-care ultrasonography improve the prediction and success of UVC placement in neonates ? The secondary aim was to assess the effectiveness of ultrasound-guided navigation with corrective maneuvers for correct UVC placement.

详细描述

Umbilical venous catheterization are used in infants who are critically ill to ensure reliable central access, allowing for the administration of parenteral nutrition and medications. Catheterization of the umbilical vein involves numerous potential complications. A large proportion of these complications results from incorrect catheter positioning. Catheter tip may be malpositioned, with reported failure rates of up to 50%, which may be associated with an increased risk of complications. Thoracoabdominal radiography (TAR) has long been the standard approach for confirming catheter tip position. Clinical studies have consistently demonstrated discrepancies between radiologic and ultrasonographic evaluations in determining central catheter tip position.

Point-of-care ultrasonography enables efficient vascular access and reliable assessment of catheter tip position. What more, we hope this approach aids in selecting appropriate corrective maneuvers, may reduce the number of insertion attempts.

The primary aim of the ultrasonographic assessment of umbilical venous catheter positioning was to evaluate the anatomical course of the umbilical venous and the ductus venosus, as well as their influence on the correct placement of the catheter within the umbilical vein.

The secondary objective was to evaluate the effectiveness of ultrasound-guided navigation combined with corrective maneuvers in achieving the correct placement of the UVC.

研究设计

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

入排标准

年龄范围
1 Day 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates born at at ≥24 weeks of gestational age who required parenteral nutrition during the early postnatal period.

排除标准

  • Individuals with congenital gastrointestinal tract malformations, agenesis of the ductus venosus, or those delivered prior to 24 weeks of gestation were excluded from the study.

研究组 & 干预措施

All participants who met the inclusion criteria were divided into two groups.

Group 1 (low catheter position) included participants in whom the catheter tip was located in an inappropriate position within the portal venous circulation.

Group 2 (high catheter position) included participants in whom the catheter tip was positioned above the ductus venosus within the inferior vena cava.

干预措施: Ultrasound assessment of UV-DV angle (Diagnostic Test)

All participants who met the inclusion criteria were divided into two groups.

Group 1 (low catheter position) included participants in whom the catheter tip was located in an inappropriate position within the portal venous circulation.

Group 2 (high catheter position) included participants in whom the catheter tip was positioned above the ductus venosus within the inferior vena cava.

干预措施: Ultrasound-guided corrective maneuvers for UVC placement (Diagnostic Test)

结局指标

主要结局

Umbilical Venous-Ductus Venosus Angle

时间窗: within the first 72 hours of life

The obtuse angle (measured in degrees) between the terminal segment of the umbilical vein and the initial segment of the ductus venosus, assessed using point-of-care ultrasound.

次要结局

  • Comparison of the umbilical venous-ductus venosus angle between low and high umbilical venous catheter positioning(within the first 72 hours of life)
  • Success Rate of Ultrasound-Guided Maneuvers(within the first 72 hours of life)
  • Causes of Umbilical Venous Catheter Malposition(within the first 72 hours of life)

研究者

发起方
Princess Anna Mazowiecka Hospital, Warsaw, Poland
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验