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

NCT01543360 | Completed

• 2 other identifiers: LOCAL/2011/JYL-GB-012011-A01353-38
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Venous Catheterization

Keywords

axillary vein; sub clavian vein; comparison of strategies

Outcome Measures

Primary Outcomes (1)

• Central venous catheter established within first 2 puncture attempts

  yes/no

  approximately 3 minutes

Secondary Outcomes (5)

• Central venous catheter established upon first punction attempt

  approximately 3 minutes

• Establishment of a central venous catheter

  approximately 3 minutes

• The time necessary for the establishment of a central venous catheter

  approximately 3 minutes

• The time necessary for the establishment of a central venous catheter

  approximately 3 minutes

• presence/absence of complications

  Day 1

Study Arms (2)

Axillary strategy

ACTIVE COMPARATOR

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).

Procedure: Axillary strategy

Subclavian strategy

ACTIVE COMPARATOR

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).

Procedure: Subclavian strategy

Interventions

Axillary strategy 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.

Axillary strategy

Subclavian strategy 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.

Subclavian strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

Location

Related Publications (1)

• 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.

  PMID: 26787790 RESULT

Study Officials

• Jean Yves Lefrant, MD PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: March 5, 2012
• Study Start: June 1, 2012
• Primary Completion: May 23, 2013
• Study Completion: May 23, 2013
• Last Updated: November 19, 2025

Record last verified: 2015-03

Locations

FR (1)