Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein (JI vs SC)

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.

Study Overview

• Status: Completed
• Conditions: Central Venous Access
• Intervention / Treatment: Procedure: Central venous catheterization

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subclavian vein access	Procedure: Central venous catheterization; Central venous catheterization via either internal jugular vein or subclavian vein up to a maximum of two attempts.
Experimental: Internal jugular vein access	Procedure: Central venous catheterization; Central venous catheterization via either internal jugular vein or subclavian vein up to a maximum of two attempts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful placement catheter from a maximum of two attempts	Binary yes/no	During procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumothorax	binary yes/no	1 day
arterial puncture	binary yes/no	within 1 hour
failure	binary yes/no	within 1 hour
arrhythmia	binary yes/no	within 1 hour
abberant placement of catheter	binary yes/no	1 day
catheter infection	binary yes/no	at removal of catheter; on average 6.5 days
catheter colonization	binary yes/no	at removal of catheter; on average 6.5 days
mediastinal hematoma	binary yes/no	1 day
thrombosis	binary yes/no	until removal of catheter; on average 6.5 days
success at first attempt	yes/no	within 1 hour
time between puncture until insertion of guide	measure in seconds	within 1 hour
clinical variables associated with failure of the techniques		within 24 hours
number of dressings	per day	over length of hospitalization; maximum 40 days
nurse-rated satisfaction at each dressing replacement	score 0-10	over length of hospitalization; maximum 40 days
haemothorax	binary yes/no	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Claire Roger, MD, CHU Nîmes

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2017
• Primary Completion (Actual): July 25, 2018
• Study Completion (Actual): July 25, 2018

Study Registration Dates

• First Submitted: May 12, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Estimated): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutics; Surgical Procedures, Operative; Catheterization; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Catheterization, Central Venous
• Other Study ID Numbers: Local/2016/CR-02; 2016-A01400-51 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No