Clinical trial NCT01543360: Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance
Official title: Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance: a Prospective, Randomized, Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Catheterization
Keywords: axillary vein
sub clavian vein
comparison of strategies
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Central venous catheter established within first 2 puncture attempts
timeFrame: approximately 3 minutes
Secondary outcomes:
measure: Central venous catheter established upon first punction attempt
timeFrame: approximately 3 minutes
measure: Establishment of a central venous catheter
timeFrame: approximately 3 minutes
measure: The time necessary for the establishment of a central venous catheter
timeFrame: approximately 3 minutes
measure: The time necessary for the establishment of a central venous catheter
timeFrame: approximately 3 minutes
measure: presence/absence of complications
timeFrame: Day 1
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean Yves Lefrant, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.