- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02894073
Interest of a Skin Transilluminator (Such as the VeinViewer®Vision Device) for Peripheral Venous Catheter Placement in the Obese Patient (VEINVIEW)
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
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Investigators
- Principal Investigator: Youssef ALAMI CHENTOUFI, MD, CHU Amiens
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PI2015_843_0010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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