Standard Ultrasound Guidance vs. New Needle-steering Device in Subclavian Venous Catheterization (NCT06050902) | Clinical Trial Compass
CompletedNot Applicable
Standard Ultrasound Guidance vs. New Needle-steering Device in Subclavian Venous Catheterization
France124 participantsStarted 2024-01-16
Plain-language summary
Up to two-thirds of intensive care unit patients require central venous catheterization for which ultrasound-guided placement is now recommended. In this context, the team performed a prospective randomized simulation trial on a mannequin ("reduced torso model"), to compare the standard ultrasound guidance technique with an ultrasound-guided technique assisted by a new needle-steering device. The preliminary results show a statistically significant improvement in subclavian venipuncture (shorter success time, fewer multiple skin punctures, fewer punctures of the posterior wall of the subclavian vein and needle redirection, greater comfort) and argue for a clinical trial to test the performance of this new device in situation with intensive care unit patients.
The hypothesis is that the needle-steering device will result in a better success rate of subclavian venous cannulation, at first puncture, compared with the conventional ultrasound-guided technique.
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:
* Any resuscitation patient requiring subclavian venous catheterization.
* Patients or representatives must have given free, informed consent and signed the consent form or patient included in an emergency situation
* Patients must be affiliated to/or beneficiary of a health insurance scheme.
* All patients must be adults (≥18 years of age).
Exclusion Criteria:
* Moribund patients
* Patients with severe primary or secondary hemostasis disorders (Pq \< 50 G/L or TP \< 30%, or INR \> 2).
* Patients with a PaO2/FiO2 ratio \< 100 mmHg in mechanically ventilated patients (invasive or non-invasive ventilation).
* Patients with a precarious or unstable respiratory status and significant risk of barotrauma
* Patients for whom it is difficult to visualize the subclavian veins bilaterally (left and right) during ultrasound pre-screening
* Patients with a malformation/deformity of the subclavian region (congenital or acquired: history of surgery/cervical trauma)
* Body mass index \< 15 kg/m² ou \> 40 kg/m²
* Local infection at the puncture site
* Thrombosis of the subclavian or axillary vein
* Patients participating in a category 1 defined RIPH involving subclavian central venous line placement.
* Patients under court protection, guardianship or curatorship.
* Pregnant, parturient or breastfeeding women.
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 catheter insertion at first skin puncture: Control group
Timeframe: Day 0
2
Successful catheter insertion at first skin puncture: Experimental group