Retrograde Femoral CatheterismFAP-ECHONCT02878915
Ultrasound-guided Femoral Arterial Puncture for Interventional Neuro-radiology in Children
A study testing Ultrasound guided femoral puncture in people with Retrograde Femoral Catheterism, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Retrograde Femoral Catheterism
- What is being tested?
- Ultrasound guided femoral puncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2015to 28 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- requirement of retrograde femoral arterial catheterism
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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,.
Read the 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.
- Conditions
- Retrograde Femoral Catheterism
- Being tested
- Ultrasound guided femoral puncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided femoral punctureDevice
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided femoral puncture | Active comparator | Ultrasound guided femoral puncture Receives: Device: Ultrasound guided femoral puncture |
| Palpation guided femoral puncture | No intervention | Palpation guided femoral puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start17 Nov 2015
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retrograde Femoral CatheterismStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Raphaël Blanc, MD, Principal investigator, Fondation Ophtalmologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878915
- Sponsor's protocol ID
- RBC_2014-34
- Acronym
- FAP-ECHO
- Status last verified
- Jan 2026
- First submitted
- 22 Aug 2016
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Interest of Ultrasound-guided Femoral Arterial Puncture for Interventional Neuro-radiology in Children
- ClinicalTrials.gov ID
- NCT02878915
- Acronym / sponsor ID
- FAP-ECHO / RBC_2014-34
- Conditions
- Retrograde Femoral Catheterism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- 28 Oct 2024 (actual)
- Study completion
- 28 Oct 2024 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided femoral puncture | Active comparator | Device: Ultrasound guided femoral punctureUltrasound guided femoral puncture |
| Palpation guided femoral puncture | No intervention | –Palpation guided femoral puncture |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- requirement of retrograde femoral arterial catheterism
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided femoral puncture | Device | Ultrasound guided femoral puncture |
Primary outcome
Demonstrate that ultrasound guidance improves the success rate at the 1st attempt
Time frame: immediate
The success rate of catheterisation in the 1st trial will be analysed as the main criterion and compared between the two groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphaël Blanc, MD principal investigator
Fondation Ophtalmologique Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided femoral puncture in people with Retrograde Femoral Catheterism, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate that ultrasound guidance improves the success rate at the 1st attempt (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.