search
Back to results

Evaluation of Accuvein in Cirrhotics Patients (CIRRVVUS)

Primary Purpose

Liver Cirrhosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cannulation with AccuVein AV400
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Liver Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Caen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental : Cannulation with AccuVein AV400

Control

Arm Description

Cirrhotic patients benefit from the support of a venous illumination device for each peripheral venous cannulation

Cirrhotic patients benefit from the standard technique of peripheral veinous catheter placement.

Outcomes

Primary Outcome Measures

First Attempt Success Rate of Cannulation
Firt attempt success of positional for each peripheral venous catheter and expressed as a percentage in cirrhotic patients during hospitalization.

Secondary Outcome Measures

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

Full Information

First Posted
June 5, 2019
Last Updated
August 23, 2022
Sponsor
University Hospital, Caen
search

1. Study Identification

Unique Protocol Identification Number
NCT03996135
Brief Title
Evaluation of Accuvein in Cirrhotics Patients
Acronym
CIRRVVUS
Official Title
Study of the Effectiveness of a Venous Illumination System for Peripheral Venous Pathways in Cirrhotic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental : Cannulation with AccuVein AV400
Arm Type
Experimental
Arm Description
Cirrhotic patients benefit from the support of a venous illumination device for each peripheral venous cannulation
Arm Title
Control
Arm Type
No Intervention
Arm Description
Cirrhotic patients benefit from the standard technique of peripheral veinous catheter placement.
Intervention Type
Device
Intervention Name(s)
Cannulation with AccuVein AV400
Other Intervention Name(s)
AccuVein AV400
Intervention Description
Cannulation using AccuVein AV400 device
Primary Outcome Measure Information:
Title
First Attempt Success Rate of Cannulation
Description
Firt attempt success of positional for each peripheral venous catheter and expressed as a percentage in cirrhotic patients during hospitalization.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
change of the score A-DIVA
Description
Scores A-DIVA between beginning and end of hospitalization between the two groups
Time Frame
baseline and end of hospitalization (up to a month)
Title
Cost
Description
Cost of consumables used in euro between the two groups
Time Frame
baseline
Title
Life expectancy of the catheter
Description
Life expectancy of the catheter between the two groups
Time Frame
baseline
Title
Utilisation of a central venous catheter
Description
Use of a central venous catheter (y/n)
Time Frame
baseline
Title
Pain's score
Description
visual analogic scale
Time Frame
baseline
Title
Numbers of attempts
Description
Number of attempts between two groups
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Moiteaux
Phone
0231064542
Email
moiteaux-p@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nelly Orliac
Phone
0231063082
Email
orliac-n@chu-caen.fr
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Moiteaux
Phone
+33231063106
Email
moiteaux-p@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Clémence Tomadesso
Phone
+33231065386
Email
tomadesso-c@chu-caen.fr

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Accuvein in Cirrhotics Patients

We'll reach out to this number within 24 hrs