Interest of a Skin Transilluminator (Such as the VeinViewer®Vision Device) for Peripheral Venous Catheter Placement in the Obese Patient (VEINVIEW)

August 20, 2018 updated by: Centre Hospitalier Universitaire, Amiens

Interest of a Skin Transilluminator (Such as the VeinViewer®Vision Device) for Peripheral Venous Catheter Placement in the Obese Patient: a Randomized, Controlled Pilot Study

Placement of a peripheral venous catheter (PVC) is the most common invasive procedure in anaesthesia and perhaps even in the field of medicine as a whole.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Placement of a peripheral venous catheter (PVC) is the most common invasive procedure in anaesthesia and perhaps even in the field of medicine as a whole. This procedure may be challenging in the obese patient - even for the most experienced healthcare professionals.

In a study, PVC placement was considered to be difficult in 46% of obese patients but only 13% of non-obese patients.

Placement of a central venous catheter is an option when PVC placement is impossible, although central access is associated with a non-negligible risk of complications (pneumothorax, infection, arterial puncture, etc.).

Facilitating peripheral venous access in obese patients should shorten the time required for PVC placement, decrease the number of perfusion attempts (a source of dissatisfaction and discomfort for the patients) and limit the use of a central venous catheter.

Although a number of novel vein visualisation devices (such as the VeinViewer®Vision from Christie Medical) have been developed to guide PVC placement, there are no literature data on the value of these devices in the management of difficult venous access in obese patients.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amiens, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All obese adult patients scheduled for surgery.
  • Social security coverage

Exclusion Criteria:

  • Age <18.
  • Contra-indication to PVC placement.
  • Legal guardianship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
PVC placement performed in the usual manner: visual inspection of the patient's anatomy
Experimental: visualisation group
a skin transilluminator (such as the VeinViewer®Vision) is used to guide PVC placement
VeinViewer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of the PVC placement procedure
Time Frame: Day 0
the time between the first puncture and the confirmation of successful PVC placement via the injection of physiological saline
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Youssef ALAMI CHENTOUFI, MD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2017

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 5, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PI2015_843_0010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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