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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07434102
Enrollment
78
Registered
2026-02-25
Start date
2021-09-22
Completion date
2023-01-23
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anatomy of the Ductus Venosus, Umbilical Venous Catheterization

Keywords

ductus venosus, umbilical venous catheter positioning, umbilical vein-ductus venosus angle, ultrasound assessment

Brief 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.

Interventions

DIAGNOSTIC_TESTUltrasound 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_TESTUltrasound-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.

Sponsors

Princess Anna Mazowiecka Hospital, Warsaw, Poland
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 3 Days
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Umbilical Venous-Ductus Venosus Anglewithin the first 72 hours of lifeThe 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.

Secondary

MeasureTime frameDescription
Comparison of the umbilical venous-ductus venosus angle between low and high umbilical venous catheter positioningwithin the first 72 hours of lifeThe umbilical vein-ductus venosus (UV-DV) angle measured by point-of-care ultrasound was compared between neonates with low-positioned and high-positioned umbilical venous catheters.
Success Rate of Ultrasound-Guided Maneuverswithin the first 72 hours of lifeProportion of participants with initially malpositioned umbilical venous catheters in whom correct catheter position is achieved after ultrasound-guided maneuvers
Causes of Umbilical Venous Catheter Malpositionwithin the first 72 hours of lifeFrequency and type of identified causes of catheter malposition detected during ultrasound assessment

Countries

Poland

Contacts

PRINCIPAL_INVESTIGATORKamil Gierek, M.D.

Department of Neonatology with Neonatal Intensive Care Unit, University Clinical Hospital in Rzeszów, Chopina 2, 35-055 Rzeszów, Poland

STUDY_CHAIRRenata Bokiniec, Prof. M.D.

Department of Neonatology and Neonatal Intensive Care Medical University of Warsaw, Karowa 2

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026