FAP-ECHO: Ultrasound-guided Femoral Arterial Puncture for Interventional Neuro-radiology in Children
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Recruiting
CT.gov ID
NCT02878915
Collaborator
(none)
150
1
2
95.5
1.6
Study Details
Study Description
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,.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Assessing the Interest of Ultrasound-guided Femoral Arterial Puncture for Interventional Neuro-radiology in Children
Actual Study Start Date
:
Nov 17, 2015
Anticipated Primary Completion Date
:
Feb 1, 2023
Anticipated Study Completion Date
:
Nov 1, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Ultrasound guided femoral puncture
|
Device: Ultrasound guided femoral puncture
|
| No Intervention: palpation guided femoral puncture
|
Outcome Measures
Primary Outcome Measures
- success rate at first attempt [immediate]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- requirement of retrograde femoral arterial catheterism
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondation Ophtalmologique Adolphe de Rothschild | Paris | France | 75019 |
Sponsors and Collaborators
- Fondation Ophtalmologique Adolphe de Rothschild
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT02878915
Other Study ID Numbers:
- RBC_2014-34
First Posted:
Aug 25, 2016
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No