Evaluation of Accuvein in Obese Patients (AVO)

May 18, 2017 updated by: Hopital Foch
The objective of this study is to evaluate the effectiveness of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients. This clinical protocol is designed to determine whether using Accuvein increases the ease and efficiency of venous cannulation (as perceived by the operator), decreases the time to effective cannulation, and decreases the patient's perception of the pain.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

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

  • France
    • Hauts de Seine
      • Levallois-Perret, Hauts de Seine, France, 92300
        • Institut Hospitalier Franco-Britannique

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:

  • obese adults ( BMI equal or greater 35) requiring a venous blood sampling or the placement of a venous peripheral catheter

Exclusion Criteria:

  • pregnant woman

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Accuvein
Use of Accuvein to facilitate placement of peripheral intravenous catheters in obese patients
Device: Accuvein
ACTIVE_COMPARATOR: Routine technique
Routine technique used to insert a peripheral intravenous catheters in obese patients.
Device: Routine technique
Placement of peripheral intravenous catheters using the routine technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of success of the first vein puncture
Time Frame: one hour
Successful successful placement of IV catheter
one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of evaluation of the device
Time Frame: one hour
Evaluation of the device by the operator and the patient
one hour

Collaborators and Investigators

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

Sponsor

Hopital Foch

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

November 1, 2013

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 13, 2013

First Posted (ESTIMATE)

December 19, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2017

Last Update Submitted That Met QC Criteria

May 18, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2013/19
  • 2013-A00777-38 (OTHER: ANSM)

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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