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Completed

NCT Number: NCT03162757

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Central venous catheterization

Procedure

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

Primary outcomes

  1. Successful placement catheter from a maximum of two attempts

    Time frame: During procedure

    Binary yes/no

Secondary outcomes

  1. Pneumothorax

    Time frame: 1 day

    binary yes/no

  2. arterial puncture

    Time frame: within 1 hour

    binary yes/no

  3. failure

    Time frame: within 1 hour

    binary yes/no

  4. arrhythmia

    Time frame: within 1 hour

    binary yes/no

  5. abberant placement of catheter

    Time frame: 1 day

    binary yes/no

  6. catheter infection

    Time frame: at removal of catheter; on average 6.5 days

    binary yes/no

  7. catheter colonization

    Time frame: at removal of catheter; on average 6.5 days

    binary yes/no

  8. mediastinal hematoma

    Time frame: 1 day

    binary yes/no

  9. thrombosis

    Time frame: until removal of catheter; on average 6.5 days

    binary yes/no

  10. success at first attempt

    Time frame: within 1 hour

    yes/no

  11. time between puncture until insertion of guide

    Time frame: within 1 hour

    measure in seconds

  12. clinical variables associated with failure of the techniques

    Time frame: within 24 hours

  13. number of dressings

    Time frame: over length of hospitalization; maximum 40 days

    per day

  14. nurse-rated satisfaction at each dressing replacement

    Time frame: over length of hospitalization; maximum 40 days

    score 0-10

  15. haemothorax

    Time frame: 1 day

    binary yes/no

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: JI vs SC

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 22, 2017
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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