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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01543360
Enrollment
132
Registered
2012-03-05
Start date
2012-06-30
Completion date
2013-05-23
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Venous Catheterization

Keywords

axillary vein, sub clavian vein, comparison of strategies

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.

Interventions

PROCEDUREAxillary 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.

PROCEDURESubclavian 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Central venous catheter established within first 2 puncture attemptsapproximately 3 minutesyes/no

Secondary

MeasureTime frameDescription
Establishment of a central venous catheterapproximately 3 minutesyes/no
Central venous catheter established upon first punction attemptapproximately 3 minutesyes/no
The time necessary for the establishment of a central venous catheterapproximately 3 minutesFor 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
presence/absence of complicationsDay 1arterial puncture (yes / no), pneumothorax (yes / no), hemothorax (yes / no), hematoma (yes / no), nerve injury (yes / no), aberrant course (yes / no)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026