3V- Improve Venous Access in Pediatric Anesthesia

This study has been completed.
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: August 5, 2014
Last verified: August 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 ]

Enrollment: 311
Study Start Date: October 2012
Study Completion Date: March 2014
Primary Completion Date: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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: August 5, 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 September 16, 2014