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

NCT ID: NCT03162757

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-26
• Study Completion Date: 2018-07-25

Brief 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). 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.

Conditions

Central Venous Access

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subclavian vein access

Group Type: EXPERIMENTAL

Central venous catheterization

Intervention Type: PROCEDURE

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

Internal jugular vein access

Group Type: EXPERIMENTAL

Central venous catheterization

Intervention Type: PROCEDURE

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

Interventions

Central venous catheterization

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire Roger, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

CHU Nimes

Nîmes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 36385459 (View on PubMed)

Other Identifiers

2016-A01400-51

Identifier Type: OTHER

Identifier Source: secondary_id

Local/2016/CR-02

Identifier Type: -

Identifier Source: org_study_id