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

Not Applicable

Completed

• Conditions: Central Venous Access
• Interventions: Procedure: Central venous catheterization

• Registration Number: NCT03162757
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-26
• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Primary Completion: 2018-07-25
• Study Completion: 2018-11-23
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subclavian vein access	Central venous catheterization	-
Internal jugular vein access	Central venous catheterization	-

Primary Outcome Measures

Name	Time	Method
Successful placement catheter from a maximum of two attempts	During procedure	Binary yes/no

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France