NCT07434102

Ultrasound Assessment for Predicting Optimal Umbilical Venous Catheter Placement

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 1 Day – 3 Days
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Anatomy of the Ductus Venosus
• Umbilical Venous Catheterization

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasound assessment of UV-DV angle	Ultrasound measurement of the umbilical vein-ductus venosus (UV-DV) angle in neonates undergoing umbilical venous catheter placement, with assessment according to catheter tip position.
DIAGNOSTIC_TEST	Ultrasound-guided corrective maneuvers for UVC placement	Real-time ultrasound-guided corrective maneuvers were performed to reposition umbilical venous catheters initially located in a low position, with advancement of the catheter toward the correct anatomical location.

Timeline

• Start date: 2021-09-22
• Primary completion: 2023-01-23
• Completion: 2023-01-23
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

2 sites across 1 country: Poland