Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Central Venous Catheterization

Treatments: Procedure: Axillary strategy; Procedure: Subclavian strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT01543360

LOCAL/2011/JYL-GB-01

2011-A01353-38 (Other Identifier)

Details and patient eligibility

About

The main objective of this study is to compare the rate of successful establishment of a central venous catheter in the first two attempts of ultrasound-guided puncture between two techniques: (1) a subclavian technique versus (2) an axillary technique.

Full description

The secondary objectives of this study are to compare the following between the two techniques:

• the success rate of the establishment of a central venous catheter
• the success rate of establishment of a central venous catheter at the first attempt at venipuncture
• for non-failures (eg, a catheter is placed in the first four trys), time to cannulation
• the presence / absence of the following complications:
• arterial puncture (yes / no)
• pneumothorax (yes / no)
• hemothorax (yes / no)
• hematoma (yes / no)
• nerve injury (yes / no)
• aberrant course (yes / no)

The reasons catheter placement failures will also be described.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 24 hours of follow-up
• Patient requiring the establishment of a central venous catheter

Exclusion criteria

• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• Patient has a body mass index < 15 or > 40
• Congenital or acquired anatomical deformity (radiation therapy, trauma, surgery) of the axillary and/or subclavian regions
• Bleeding disorder (platelets < 50,000, prothrombine < 50%, activated cephaline time > 2 times the control value)
• Severe hypoxemia defined by a ratio PaO2 / FIO2 < 100
• Infection of the puncture area
• Known thrombosis of the subclavian or axillary veins
• Scheduled length of hospitalization less than 24 hours
• Agitated or non-cooperative patient
• The patient has already been included in this study
• subclavian and axillary veins are not simultaneously echogenic on one or both sides (left and right).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

132 participants in 2 patient groups

Axillary strategy

Active Comparator group

Description:

The first two attempts at central venous catheterization will be performed via the distal approach (axillary vein). The third and fourth attempts at central venous catheterization will be performed by the medial approach (subclavian vein).

Treatment:

Procedure: Axillary strategy

Subclavian strategy

Active Comparator group

Description:

The first two attempts at central venous catheterization will be performed by the medial approach (subclavian vein). The third and fourth attempts at central venous catheterization will be performed by the distal approach (axillary vein).

Treatment:

Procedure: Subclavian strategy