Evaluation of Accuvein in Cirrhotics Patients

Liver Cirrhosis Clinical Trial

— CIRRVVUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03996135
• Other study ID #: 19-043
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: University Hospital, Caen
• Contact: Philippe Moiteaux
• Phone: 0231064542
• Email: moiteaux-p[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Device:
• Cannulation with AccuVein AV400
Cannulation using AccuVein AV400 device

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

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