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

Not Applicable

Completed

• Conditions: Central Venous Catheterization

• Registration Number: NCT01543360
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2012-02-20
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Study Start: 2012-06
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Central venous catheter established within first 2 puncture attempts	approximately 3 minutes	yes/no

Secondary Outcome Measures

Name	Time	Method
Central venous catheter established upon first punction attempt	approximately 3 minutes	yes/no
The time necessary for the establishment of a central venous catheter	approximately 3 minutes	all cases, in minutes
presence/absence of complications	Day 1	arterial puncture (yes / no), pneumothorax (yes / no), hemothorax (yes / no), hematoma (yes / no), nerve injury (yes / no), aberrant course (yes / no)
Establishment of a central venous catheter	approximately 3 minutes	yes/no

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, Gard, France