CClinicalTrials.gg
CompletedNCT016858663VUpdated Aug 6, 2014

3V- Improve Venous Access in Pediatric Anesthesia

An interventional study of Vein-Viewer Vision in Cardiovascular Diseases, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Completed at 2 sites in France. Open to participants aged Up to 7 Years. Per ClinicalTrials.gov, last updated 2014-08-06.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
311
Allocation
Randomized
Ages
Up to 7 Years
Sex
All
01

Study summary

Our hypothesis is that a new medical device called Vein-Viewer Vision helps to see peripheral veins in children having forecasted difficult venous access and could facilitate the venous access.The main goal is to reduce the time necessary to get a venous access during the inhalation anesthesia induction.

Read the detailed description

Randomized study comparing the delay of peripheral access with or without using the device. Monosite study, including children undergoing surgery.

02

Conditions studied

  • Cardiovascular Diseases

Keywords

  • anesthesia
  • venous access
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 311 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • children aged less than 7
  • DIVA score ≥ 4
  • patient needing venous peripheral access for general anesthesia

Exclusion criteria

Exclusion Criteria:

  • no social security
  • opposition of the parent(s) to the participation of their child in the trial
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Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
311 participants (actual)

Study arms

  • Other
    Vein-Viewer Vision

    A medical device called Vein-Viewer Vision

    Device: Vein-Viewer Vision

  • No intervention
    no medical device

    in the second arm, we use no medical device

Interventions

  • DeviceVein-Viewer Vision

    A medical device called Vein-Viewer Vision

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What researchers measure

Primary outcomes

  1. reduce the time necessary to find the venous access during inhalation anesthesia induction

    Time frame: 1 day of anesthesia

07

Study locations

2 sites
  • Robert Debré Hospital, APHP
    Paris, Ile de France 75019, France
  • Fondation ophtalmologique Adolphe de Rothschild
    Paris, Ile-de-France 75019, France
08

References and documents

Publications

  • Gras S, Roy-Gash F, Bruneau B, Salvi N, Colas AE, Skhiri A, Orliaguet G, Dahmani S, Devys JM. Reducing the time to successful intravenous cannulation in anaesthetised children with poor vein visibility using a near-infrared device: A randomised multicentre trial. Eur J Anaesthesiol. 2021 Aug 1;38(8):888-894. doi: 10.1097/EJA.0000000000001467. PubMed 33606421 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01685866
Lead sponsor
Fondation Ophtalmologique Adolphe de Rothschild
Collaborators
Ministry of Health, France
Responsible party
Sponsor
First posted
Sep 14, 2012
Start date
Oct 2012
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Aug 6, 2014

Study contacts

Jean-Michel Devys, MD
principal investigator · Fondation Ophtalmologique Adolphe de Rothschild

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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