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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 12, 2012
First Posted Date  ICMJE September 14, 2012
Last Update Posted Date August 6, 2014
Study Start Date  ICMJE October 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2012)
reduce the time necessary to find the venous access during inhalation anesthesia induction [ Time Frame: 1 day of anesthesia ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 3V- Improve Venous Access in Pediatric Anesthesia
Official Title  ICMJE Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.
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.
Detailed Description Randomized study comparing the delay of peripheral access with or without using the device. Monosite study, including children undergoing surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Condition  ICMJE Cardiovascular Diseases
Intervention  ICMJE Device: Vein-Viewer Vision
A medical device called Vein-Viewer Vision
Study Arms  ICMJE
  • Vein-Viewer Vision
    A medical device called Vein-Viewer Vision
    Intervention: Device: Vein-Viewer Vision
  • No Intervention: no medical device
    in the second arm, we use no medical device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 5, 2014)
311
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2012)
312
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01685866
Other Study ID Numbers  ICMJE SC/DM_JDS_2012-1_V1.0-20120605
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor  ICMJE Fondation Ophtalmologique Adolphe de Rothschild
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Jean-Michel Devys, MD Fondation Ophtalmologique Adolphe de Rothschild
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP