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

Study Overview
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Brief Summary
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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.

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

Conditions
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Central Venous Access

Intervention / Treatment
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* Procedure: Central venous catheterization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |