3V- Improve Venous Access in Pediatric Anesthesia

This study is currently recruiting participants.
Verified February 2014 by Fondation Ophtalmologique Adolphe de Rothschild
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT01685866
First received: September 12, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

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 Intervention
Cardiovascular Diseases
Device: Vein-Viewer Vision

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Difficult Venous Access in Pediatric Anesthesia: Evaluation of a New Medical Device in Multicenter Trial.

Further study details as provided by Fondation Ophtalmologique Adolphe de Rothschild:

Primary Outcome Measures:
  • reduce the time necessary to find the venous access during inhalation anesthesia induction [ Time Frame: 1 day of anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment: 312
Study Start Date: October 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   up to 7 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685866

Contacts
Contact: Jean-Michel DEVYS, MD 0033148036774
Contact: Laurence SALOMON, MD, PhD 0033148036431

Locations
France
Robert Debré Hospital, APHP Recruiting
Paris, Ile de France, France, 75019
Principal Investigator: Souhayl Dahmani, MD PhD         
Fondation ophtalmologique Adolphe de Rothschild Recruiting
Paris, Ile-de-France, France, 75019
Contact: Jean-Michel DEVYS, MD    +33(0)148036431    lsalomon@fo-rothschild.fr   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Ministry of Health, France
Investigators
Principal Investigator: Jean-Michel Devys, MD Fondation Ophtalmologique Adolphe de Rothschild
  More Information

No publications provided

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
Study First Received: September 12, 2012
Last Updated: February 19, 2014
Health Authority: France: Ministry of Health

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014