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

NCT ID: NCT01543360

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-05-23

Brief Summary

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.

Detailed 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.

Conditions

Central Venous Catheterization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Axillary strategy

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).

Group Type: ACTIVE_COMPARATOR

Axillary strategy

Intervention Type: PROCEDURE

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). The same puncture material/devices will be used in both arms of the study.

Subclavian strategy

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).

Group Type: ACTIVE_COMPARATOR

Subclavian strategy

Intervention Type: PROCEDURE

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). The same puncture material/devices will be used in both arms of the study.

Interventions

Axillary strategy

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). The same puncture material/devices will be used in both arms of the study.

Intervention Type: PROCEDURE

Subclavian strategy

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). The same puncture material/devices will be used in both arms of the study.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Yves Lefrant, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, France

Countries

France

References

Buzancais G, Roger C, Bastide S, Jeannes P, Lefrant JY, Muller L. Comparison of two ultrasound guided approaches for axillary vein catheterization: a randomized controlled non-inferiority trial. Br J Anaesth. 2016 Feb;116(2):215-22. doi: 10.1093/bja/aev458.

Reference Type: RESULT

PMID: 26787790 (View on PubMed)

Other Identifiers

2011-A01353-38

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2011/JYL-GB-01

Identifier Type: -

Identifier Source: org_study_id