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

Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance: a Prospective, Randomized, Non-inferiority Study

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.

Study Overview

• Status: Completed
• Conditions: Central Venous Catheterization
• Intervention / Treatment: Procedure: Axillary strategy; Procedure: Subclavian strategy

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes Cedex 09, Gard, France, 30029
      • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Procedure: 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.
Active Comparator: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central venous catheter established within first 2 puncture attempts	yes/no	approximately 3 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central venous catheter established upon first punction attempt	yes/no	approximately 3 minutes
Establishment of a central venous catheter	yes/no	approximately 3 minutes
The time necessary for the establishment of a central venous catheter	For non-failures (ie establishment of a central venous catheter within 4 puncture attempts), the number of minutes necessary for the establishment of a central venous catheter	approximately 3 minutes
The time necessary for the establishment of a central venous catheter	all cases, in minutes	approximately 3 minutes
presence/absence of complications	arterial puncture (yes / no), pneumothorax (yes / no), hemothorax (yes / no), hematoma (yes / no), nerve injury (yes / no), aberrant course (yes / no)	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jean Yves Lefrant, MD PhD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: February 20, 2012
• First Submitted That Met QC Criteria: March 2, 2012
• First Posted (Estimate): March 5, 2012

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: axillary vein; sub clavian vein; comparison of strategies
• Other Study ID Numbers: LOCAL/2011/JYL-GB-01; 2011-A01353-38 (Other Identifier: RCB number)