Evaluation of Accuvein in Cirrhotics Patients

NCT03996135 — Not applicable, Unknown, 280 participants, University Hospital, Caen

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

Registry	NCT03996135, acronym CIRRVVUS
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	280 (Estimated)
Sponsor	University Hospital, Caen (Other)
Conditions	Liver Cirrhosis
Interventions	Cannulation with AccuVein AV400 (Device)
Dates	start 2020-06-15, primary completion 2023-06-30 (estimated), completion 2023-06-30 (estimated), first posted 2019-06-24, last updated 2022-08-24
Locations	1 site in France

-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®.

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+Arms and interventions

Arm	Type	Interventions	Description
Experimental : Cannulation with AccuVein AV400	Experimental	Device: Cannulation with AccuVein AV400	Cirrhotic patients benefit from the support of a venous illumination device for each peripheral venous cannulation
Control	No intervention		Cirrhotic patients benefit from the standard technique of peripheral veinous catheter placement.

Cannulation with AccuVein AV400 (Device), also known as AccuVein AV400: Cannulation using AccuVein AV400 device

+Outcome measures

Primary outcomes

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 outcomes

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
Utilisation of a central venous catheter [baseline]: Use of a central venous catheter (y/n)
Pain's score [baseline]: visual analogic scale
Numbers of attempts [baseline]: Number of attempts between two groups

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Caen University Hospital	Caen	France	Recruiting

My Notes

Public

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