NCT02878915

Brief Summary

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,.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2024

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

9 years

First QC Date

August 22, 2016

Last Update Submit

January 21, 2026

Conditions

Retrograde Femoral Catheterism

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Ultrasound guided femoral puncture

ACTIVE COMPARATOR

Ultrasound guided femoral puncture

Device: Ultrasound guided femoral puncture

Palpation guided femoral puncture

NO INTERVENTION

Palpation guided femoral puncture

Interventions

Ultrasound guided femoral punctureDEVICE
Ultrasound guided femoral puncture

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • requirement of retrograde femoral arterial catheterism

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

Study Officials

  • Raphaël Blanc, MD

    Fondation Ophtalmologique Adolphe de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

November 17, 2015

Primary Completion

October 28, 2024

Study Completion

October 28, 2024

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)