Evaluation of Accuvein in Cirrhotics Patients (CIRRVVUS)

August 23, 2022 updated by: University Hospital, Caen

Study of the Effectiveness of a Venous Illumination System for Peripheral Venous Pathways in Cirrhotic Patients

The objective of this study is to evaluate the effectiveness of AccuVein AV400 to facilitate placement of peripheral intravenous catheters in cirrhotic adults by comparing the success rate of the first attempt to install a peripheral venous catheter with or without AccuVein AV400®.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

280

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 Contact

Study Contact Backup

Study Locations

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:

  • Patient older than 18 years old
  • Patient presenting a liver cirrhosis
  • Patient requiring the placement of a venous peripheral catheter
  • Patient informed and giving free and informed consent
  • Patient affiliated to a French social security scheme

Exclusion Criteria:

  • Patient under 18 years old
  • Patient unable to give consent
  • Patient under guardianship or curatorship

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental : Cannulation with AccuVein AV400
Cirrhotic patients benefit from the support of a venous illumination device for each peripheral venous cannulation
Device: Cannulation with AccuVein AV400
Cannulation using AccuVein AV400 device
Other Names:
  • AccuVein AV400
No Intervention: Control
Cirrhotic patients benefit from the standard technique of peripheral veinous catheter placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Attempt Success Rate of Cannulation
Time Frame: baseline
Firt attempt success of positional for each peripheral venous catheter and expressed as a percentage in cirrhotic patients during hospitalization.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of the score A-DIVA
Time Frame: baseline and end of hospitalization (up to a month)
Scores A-DIVA between beginning and end of hospitalization between the two groups
baseline and end of hospitalization (up to a month)
Cost
Time Frame: baseline
Cost of consumables used in euro between the two groups
baseline
Life expectancy of the catheter
Time Frame: baseline
Life expectancy of the catheter between the two groups
baseline
Utilisation of a central venous catheter
Time Frame: baseline
Use of a central venous catheter (y/n)
baseline
Pain's score
Time Frame: baseline
visual analogic scale
baseline
Numbers of attempts
Time Frame: baseline
Number of attempts between two groups
baseline

Collaborators and Investigators

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

Sponsor

University Hospital, Caen

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)

June 15, 2020

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-043

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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