Clinical trial NCT03162757: Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein
Official title: Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Access
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Successful placement catheter from a maximum of two attempts
timeFrame: During procedure
Secondary outcomes:
measure: Pneumothorax
timeFrame: 1 day
measure: arterial puncture
timeFrame: within 1 hour
measure: failure
timeFrame: within 1 hour
measure: arrhythmia
timeFrame: within 1 hour
measure: abberant placement of catheter
timeFrame: 1 day
measure: catheter infection
timeFrame: at removal of catheter; on average 6.5 days
measure: catheter colonization
timeFrame: at removal of catheter; on average 6.5 days
measure: mediastinal hematoma
timeFrame: 1 day
measure: thrombosis
timeFrame: until removal of catheter; on average 6.5 days
measure: success at first attempt
timeFrame: within 1 hour
measure: time between puncture until insertion of guide
timeFrame: within 1 hour
measure: clinical variables associated with failure of the techniques
timeFrame: within 24 hours
measure: number of dressings
timeFrame: over length of hospitalization; maximum 40 days
measure: nurse-rated satisfaction at each dressing replacement
timeFrame: over length of hospitalization; maximum 40 days
measure: haemothorax
timeFrame: 1 day
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Claire Roger, MD
role: PRINCIPAL_INVESTIGATOR
References: