NCT01685866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

1.4 years

First QC Date

September 12, 2012

Last Update Submit

August 5, 2014

Conditions

Cardiovascular Diseases

Keywords

anesthesiavenous access

Outcome Measures

Primary Outcomes (1)

  • reduce the time necessary to find the venous access during inhalation anesthesia induction

    1 day of anesthesia

Study Arms (2)

Vein-Viewer Vision

OTHER

A medical device called Vein-Viewer Vision

Device: Vein-Viewer Vision

no medical device

NO INTERVENTION

in the second arm, we use no medical device

Interventions

Vein-Viewer VisionDEVICE

A medical device called Vein-Viewer Vision

Vein-Viewer Vision

Eligibility Criteria

AgeUp to 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children aged less than 7
  • DIVA score ≥ 4
  • patient needing venous peripheral access for general anesthesia

You may not qualify if:

  • no social security
  • opposition of the parent(s) to the participation of their child in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondation ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, 75019, France

Location

Robert Debré Hospital, APHP

Paris, Île-de-France Region, 75019, France

Location

Related Publications (1)

  • Gras S, Roy-Gash F, Bruneau B, Salvi N, Colas AE, Skhiri A, Orliaguet G, Dahmani S, Devys JM. Reducing the time to successful intravenous cannulation in anaesthetised children with poor vein visibility using a near-infrared device: A randomised multicentre trial. Eur J Anaesthesiol. 2021 Aug 1;38(8):888-894. doi: 10.1097/EJA.0000000000001467.

    PMID: 33606421DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Jean-Michel Devys, MD

    Fondation Ophtalmologique Adolphe de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 14, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations

FR(2)