Central Venous CatheterizationNCT01543360
Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance
A study testing Axillary strategy and Subclavian strategy in people with Central Venous Catheterization, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheterization
- What is being tested?
- Axillary strategy and Subclavian strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to 23 May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Central Venous Catheterization
- Being tested
- Axillary strategy, Subclavian strategy
- Keywords
- axillary vein, sub clavian vein, comparison of strategies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary strategyProcedure or surgery
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.
Subclavian strategyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Axillary strategy | Active comparator | 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). Receives: Procedure: Axillary strategy |
| Subclavian strategy | Active comparator | 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). Receives: Procedure: Subclavian strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central venous catheter established within first 2 puncture attempts
yes/no
Measured: approximately 3 minutes
Secondary outcomes (5)
Central venous catheter established upon first punction attempt
yes/no
Measured: approximately 3 minutes
Establishment of a central venous catheter
yes/no
Measured: 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
Measured: approximately 3 minutes
The time necessary for the establishment of a central venous catheter
all cases, in minutes
Measured: 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)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJun 2012
- Primary completion23 May 2013
- Study completion23 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Venous CatheterizationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Yves Lefrant, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543360
- Sponsor's protocol ID
- LOCAL/2011/JYL-GB-01
- Other IDs
- 2011-A01353-38
- Status last verified
- Mar 2015
- First submitted
- 20 Feb 2012
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26787790
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance: a Prospective, Randomized, Non-inferiority Study
- ClinicalTrials.gov ID
- NCT01543360
- Acronym / sponsor ID
- LOCAL/2011/JYL-GB-01
- Conditions
- Central Venous Catheterization
- Keywords
- axillary vein, sub clavian vein, comparison of strategies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- 23 May 2013 (actual)
- Study completion
- 23 May 2013 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axillary strategy | Active comparator | Procedure: Axillary 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 strategy | Active comparator | Procedure: Subclavian 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axillary 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). The same puncture material/devices will be used in both arms of the study. | Procedure or surgery | Axillary strategy |
| Subclavian 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). The same puncture material/devices will be used in both arms of the study. | Procedure or surgery | Subclavian strategy |
Primary outcome
Central venous catheter established within first 2 puncture attempts
Time frame: approximately 3 minutes
yes/no
5 secondary outcomes
Central venous catheter established upon first punction attempt
Time frame: approximately 3 minutes
Establishment of a central venous catheter
Time frame: approximately 3 minutes
The time necessary for the establishment of a central venous catheter
Time frame: approximately 3 minutes
The time necessary for the establishment of a central venous catheter
Time frame: approximately 3 minutes
presence/absence of complications
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 26787790Buzancais 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Yves Lefrant, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary strategy and Subclavian strategy in people with Central Venous Catheterization, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central venous catheter established within first 2 puncture attempts (time frame: approximately 3 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01543360, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.