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Ultrasound-guided Femoral Arterial Puncture for Interventional Neuro-radiology in Children

NCT ID: NCT02878915

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-17

Study Completion Date

2024-10-28

Brief Summary

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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,.

Detailed Description

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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.

Conditions

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Retrograde Femoral Catheterism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Ultrasound guided femoral puncture

Ultrasound guided femoral puncture

Group Type ACTIVE_COMPARATOR

Ultrasound guided femoral puncture

Intervention Type DEVICE

Palpation guided femoral puncture

Palpation guided femoral puncture

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ultrasound guided femoral puncture

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* requirement of retrograde femoral arterial catheterism

Exclusion Criteria

* none
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raphaël Blanc, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique Adolphe de Rothschild

Locations

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Fondation Ophtalmologique Adolphe de Rothschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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RBC_2014-34

Identifier Type: -

Identifier Source: org_study_id