3V- Improve Venous Access in Pediatric Anesthesia

NCT ID: NCT01685866

Last Updated: 2014-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-03-31

Brief Summary

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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

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

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vein-Viewer Vision

A medical device called Vein-Viewer Vision

Group Type OTHER

Vein-Viewer Vision

Intervention Type DEVICE

A medical device called Vein-Viewer Vision

no medical device

in the second arm, we use no medical device

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vein-Viewer Vision

A medical device called Vein-Viewer Vision

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Michel Devys, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique Adolphe de Rothschild

Locations

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Fondation ophtalmologique Adolphe de Rothschild

Paris, Île-de-France Region, France

Site Status

Robert Debré Hospital, APHP

Paris, Île-de-France Region, France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 33606421 (View on PubMed)

Other Identifiers

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SC/DM_JDS_2012-1_V1.0-20120605

Identifier Type: -

Identifier Source: org_study_id

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