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

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ClinicalTrials.gov Identifier: NCT01685866
Recruitment Status : Completed
First Posted : September 14, 2012
Last Update Posted : August 6, 2014
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Device: Vein-Viewer Vision Not Applicable

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  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.
Study Start Date : October 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. reduce the time necessary to find the venous access during inhalation anesthesia induction [ Time Frame: 1 day of anesthesia ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685866


Locations
France
Robert Debré Hospital, APHP
Paris, Ile de France, France, 75019
Fondation ophtalmologique Adolphe de Rothschild
Paris, Ile-de-France, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Ministry of Health, France
Investigators
Principal Investigator: Jean-Michel Devys, MD Fondation Ophtalmologique Adolphe de Rothschild

Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT01685866     History of Changes
Other Study ID Numbers: SC/DM_JDS_2012-1_V1.0-20120605
First Posted: September 14, 2012    Key Record Dates
Last Update Posted: August 6, 2014
Last Verified: August 2014

Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
anesthesia
venous access

Additional relevant MeSH terms:
Cardiovascular Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs