3V- Improve Venous Access in Pediatric Anesthesia (3V)

August 5, 2014 updated by: Fondation Ophtalmologique Adolphe de Rothschild

Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

311

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Paris, Ile de France, France, 75019
        • Robert Debré Hospital, APHP
    • Ile-de-France
      • Paris, Ile-de-France, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Vein-Viewer Vision
A medical device called Vein-Viewer Vision
Device: Vein-Viewer Vision
A medical device called Vein-Viewer Vision
NO_INTERVENTION: no medical device
in the second arm, we use no medical device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
reduce the time necessary to find the venous access during inhalation anesthesia induction
Time Frame: 1 day of anesthesia
1 day of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Collaborators

Ministry of Health, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 13, 2012

First Posted (ESTIMATE)

September 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC/DM_JDS_2012-1_V1.0-20120605

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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