NCT03162757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 26, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2018

Completed
Last Updated

November 21, 2025

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

May 12, 2017

Last Update Submit

November 18, 2025

Conditions

Central Venous Access

Outcome Measures

Primary Outcomes (1)

  • Successful placement catheter from a maximum of two attempts

    Binary yes/no

    During procedure

Secondary Outcomes (15)

  • Pneumothorax

    1 day

  • arterial puncture

    within 1 hour

  • failure

    within 1 hour

  • arrhythmia

    within 1 hour

  • abberant placement of catheter

    1 day

  • +10 more secondary outcomes

Study Arms (2)

Subclavian vein access

EXPERIMENTAL
Procedure: Central venous catheterization

Internal jugular vein access

EXPERIMENTAL
Procedure: Central venous catheterization

Interventions

Central venous catheterizationPROCEDURE

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

Internal jugular vein accessSubclavian vein access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

    PMID: 36385459RESULT

MeSH Terms

Interventions

Catheterization, Central Venous

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Claire Roger, MD

    CHU Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2017

First Posted

May 22, 2017

Study Start

January 26, 2017

Primary Completion

July 25, 2018

Study Completion

July 25, 2018

Last Updated

November 21, 2025

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)