Evaluation of Accuvein in Cirrhotics Patients

Not Applicable

• Conditions: Liver Cirrhosis
• Interventions: Device: Cannulation with AccuVein AV400

• Registration Number: NCT03996135
• Lead Sponsor: University Hospital, Caen

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®.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Study Start: 2020-06-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-24
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental : Cannulation with AccuVein AV400	Cannulation with AccuVein AV400	Cirrhotic patients benefit from the support of a venous illumination device for each peripheral venous cannulation

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France