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Central Venous AccessJI vs SCNCT03162757

Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein

A study testing Central venous catheterization in people with Central Venous Access, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this pilot study is to establish the success rate of catheterization of the lower jugular vein and the subclavian vein under ultrasound guidance in real time. The purpose is to compare the two techniques and to determine the best design for a full study (superiority, non-inferiority). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Central Venous Access
What is being tested?
Central venous catheterization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteFrance
Study dates
26 Jan 2017to 25 Jul 2018
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 has been, or will be, informed as soon as their state of health allows them to be entered into the study of its objectives, constraints and the patient's rights
  • The patient have given their free and informed consent and signed the consent form
  • The patient must be insured or a beneficiary of a health insurance plan
  • The patient is over 18 years old
  • The patient needs a venous catheter in the superior vena cava

Who cannot join

  • The patient is already participating in another interventional study that could influence the results of this study
  • The patient has participated in another interventional study within the previous 3 months that could influence the results of this study
  • The patient is in a period of exclusion determined by a previous study
  • The patient is under judicial protection or is an adult under guardianship
  • The patient refuses to sign the consent form
  • Non-echogenic patient
Show all 10Show fewer
  • Moribund patient
  • The patient has a contra-indication to one or other of the approaches: infection of the insertion zone, known thrombosis, severely dyspneic
  • Patient has severe coagulation problems: PT<40%, platelets<50 000 and curable anticoagulation with antiXa > 0.5 or INR>3.
  • Patient has a congenital or acquired deformation at the entry site

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Nimes

    Nîmes, 30029

Other trials in France

About this study

The aim of this pilot study is to establish the success rate of catheterization of the lower jugular vein and the subclavian vein under ultrasound guidance in real time. The purpose is to compare the two techniques and to determine the best design for a full study (superiority, non-inferiority). This is a 2-arm randomized control study. The randomization ensures the comparability of the groups and allows evaluation of the feasibility and potential bias for further comparative studies.

Being tested
Central venous catheterization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Central venous catheterizationProcedure or surgery

    Central venous catheterization via either internal jugular vein or subclavian vein up to a maximum of two attempts.

Study groups in NCT03162757
Study groupRoleWhat they receive
Subclavian vein accessExperimentalNot described
Receives: Procedure: Central venous catheterization
Internal jugular vein accessExperimentalNot described
Receives: Procedure: Central venous catheterization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful placement catheter from a maximum of two attempts

    Binary yes/no

    Measured: During procedure

Secondary outcomes (15)

  1. Pneumothorax

    binary yes/no

    Measured: 1 day

  2. arterial puncture

    binary yes/no

    Measured: within 1 hour

  3. failure

    binary yes/no

    Measured: within 1 hour

  4. arrhythmia

    binary yes/no

    Measured: within 1 hour

  5. abberant placement of catheter

    binary yes/no

    Measured: 1 day

  6. catheter infection

    binary yes/no

    Measured: at removal of catheter; on average 6.5 days

  7. catheter colonization

    binary yes/no

    Measured: at removal of catheter; on average 6.5 days

  8. mediastinal hematoma

    binary yes/no

    Measured: 1 day

  9. thrombosis

    binary yes/no

    Measured: until removal of catheter; on average 6.5 days

  10. success at first attempt

    yes/no

    Measured: within 1 hour

  11. time between puncture until insertion of guide

    measure in seconds

    Measured: within 1 hour

  12. clinical variables associated with failure of the techniques

    Measured: within 24 hours

  13. number of dressings

    per day

    Measured: over length of hospitalization; maximum 40 days

  14. nurse-rated satisfaction at each dressing replacement

    score 0-10

    Measured: over length of hospitalization; maximum 40 days

  15. haemothorax

    binary yes/no

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2017
  2. Study start26 Jan 2017
  3. Primary completion25 Jul 2018
  4. Study completion25 Jul 2018

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03162757
Sponsor's protocol ID
Local/2016/CR-02
Other IDs
2016-A01400-51
Acronym
JI vs SC
Status last verified
Jan 2019
First submitted
12 May 2017
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fournil C, Boulet N, Bastide S, Louart B, Ambert A, Boutin C, Lefrant JY, Muller L, Roger C. High success rates of ultrasound-guided distal internal jugular vein and axillary vein approaches for central venous catheterization: A randomized controlled open-label pilot trial. J Clin Ultrasound. 2023 Jan;51(1):158-166. doi: 10.1002/jcu.23383. Epub 2022 Nov 17.

    PubMed 36385459

Questions about this trial

What is this clinical trial studying?

A study testing Central venous catheterization in people with Central Venous Access, 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 5 inclusion and 10 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 21 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?

Successful placement catheter from a maximum of two attempts (time frame: During procedure). 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 NCT03162757, 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 21 Nov 2025.

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