Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein (JI vs SC)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Central Venous Access

Treatments: Procedure: Central venous catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT03162757

Local/2016/CR-02

2016-A01400-51 (Other Identifier)

Details and patient eligibility

About

The aim of this pilot study is to establish the success rate of catheterization of the lower jugular vein and the subclavian vein under ultrasound guidance in real time. The purpose is to compare the two techniques and to determine the best design for a full study (superiority, non-inferiority). This is a 2-arm randomized control study. The randomization ensures the comparability of the groups and allows evaluation of the feasibility and potential bias for further comparative studies.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has been, or will be, informed as soon as their state of health allows them to be entered into the study of its objectives, constraints and the patient's rights
• The patient have given their free and informed consent and signed the consent form
• The patient must be insured or a beneficiary of a health insurance plan
• The patient is over 18 years old
• The patient needs a venous catheter in the superior vena cava

Exclusion criteria

• The patient is already participating in another interventional study that could influence the results of this study
• The patient has participated in another interventional study within the previous 3 months that could influence the results of this study
• The patient is in a period of exclusion determined by a previous study
• The patient is under judicial protection or is an adult under guardianship
• The patient refuses to sign the consent form
• Non-echogenic patient
• Moribund patient
• The patient has a contra-indication to one or other of the approaches: infection of the insertion zone, known thrombosis, severely dyspneic
• Patient has severe coagulation problems: PT<40%, platelets<50 000 and curable anticoagulation with antiXa > 0.5 or INR>3.
• Patient has a congenital or acquired deformation at the entry site

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Subclavian vein access

Experimental group

Treatment:

Procedure: Central venous catheterization

Internal jugular vein access

Experimental group

Treatment:

Procedure: Central venous catheterization