Ultrasound-guided Femoral Arterial Puncture for Interventional Neuro-radiology in Children (FAP-ECHO)

Assessing the Interest of Ultrasound-guided Femoral Arterial Puncture for Interventional Neuro-radiology in Children

Using ultrasound to guide vascular catheterism in children is highly recommended for central venous access. It has been proven that central venous line is inserted faster, with fewer attempts and complications. Its interest in central arterial line insertion is less obvious. It seems to have benefits in adults, both for radial and femoral arterial insertion. But there is no study assessing the interest of ultrasound guided arterial puncture in children,.

Study Overview

• Status: Completed
• Conditions: Retrograde Femoral Catheterism
• Intervention / Treatment: Device: Ultrasound guided femoral puncture

Detailed Description

The use of ultrasound to guide vascular catheterization in children is strongly recommended for central venous vascular access by several international learned societies. In fact, studies have found a reduction in the time it takes to install the central venous line, in the number of attempts and in complications.The benefit of ultrasound to guide catheterization of the arterial network is less documented.

In children, there is an inventory of the traditional approach guided by palpation, in children in intensive care (11). The analysis of 77 femoral puncture attempts in 74 children was carried out. Arterial cannulation was successful in 73 of 77 cases (95%), but only in 60% of cases at the first attempt. Ultrasound guidance appears beneficial in adults for both arterial sites, radial and femoral. On the other hand, in children, unlike radial catheterization, there is no study evaluating the contribution of ultrasound guidance for femoral catheterization.

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• requirement of retrograde femoral arterial catheterism

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound guided femoral puncture	Device: Ultrasound guided femoral puncture
No Intervention: Palpation guided femoral puncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate that ultrasound guidance improves the success rate at the 1st attempt	The success rate of catheterisation in the 1st trial will be analysed as the main criterion and compared between the two groups.	immediate

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Raphaël Blanc, MD, Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2015
• Primary Completion (Actual): October 28, 2024
• Study Completion (Actual): October 28, 2024

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimated): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RBC_2014-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO