3V- Improve Venous Access in Pediatric Anesthesia

Cardiovascular Diseases Clinical Trial

— 3V  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01685866
• Other study ID #: SC/DM_JDS_2012-1_V1.0-20120605
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: August 5, 2014
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: August 2014
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Device:
• Vein-Viewer Vision
A medical device called Vein-Viewer Vision

Locations

Country	Name	City	State
France	Fondation ophtalmologique Adolphe de Rothschild	Paris	Ile-de-France
France	Robert Debré Hospital, APHP	Paris	Ile de France

Sponsors (2)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduce the time necessary to find the venous access during inhalation anesthesia induction		1 day of anesthesia	No