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

Not Applicable
Completed
Conditions
Central Venous Catheterization
Interventions
Procedure: Axillary strategy
Procedure: Subclavian strategy
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.

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
Arm && Interventions
GroupInterventionDescription
Axillary strategyAxillary strategyThe 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).
Subclavian strategySubclavian strategyThe 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).
Primary Outcome Measures
NameTimeMethod
Central venous catheter established within first 2 puncture attemptsapproximately 3 minutes

yes/no

Secondary Outcome Measures
NameTimeMethod
Establishment of a central venous catheterapproximately 3 minutes

yes/no

The time necessary for the establishment of a central venous catheterapproximately 3 minutes

all cases, in minutes

Central venous catheter established upon first punction attemptapproximately 3 minutes

yes/no

presence/absence of complicationsDay 1

arterial puncture (yes / no), pneumothorax (yes / no), hemothorax (yes / no), hematoma (yes / no), nerve injury (yes / no), aberrant course (yes / no)

Trial Locations

Locations (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

🇫🇷

Nîmes Cedex 09, Gard, France

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