Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Ve… (NCT03162757) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein
France210 participantsStarted 2017-01-26
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Successful placement catheter from a maximum of two attempts