Comparing standard ultrasound guidance to a new needle-steering device for subclavian catheter placement

Ultrasound-guided Subclavian Venous Catheterization. A Randomized, Single-blind, Controlled Superiority Trial Comparing Standard Ultrasound Guidance and a New Needle-steering Device

This study is testing if a new needle-steering device can help doctors place catheters in the subclavian vein more easily and safely than the standard ultrasound method for patients in the intensive care unit.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 124 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (other)
• Locations: 1 site (Nimes)
• Trial ID: NCT06050902 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of standard ultrasound guidance with a new needle-steering device for subclavian venous catheterization in intensive care unit patients. The study involves a prospective randomized simulation trial using a mannequin to assess the success rates, time efficiency, and complication rates associated with each technique. Preliminary results indicate that the needle-steering device may lead to shorter success times and fewer complications compared to traditional methods. The ultimate goal is to validate these findings in a clinical setting with actual patients requiring central venous catheterization.

Who should consider this trial

Good fit: Ideal candidates include adult patients in need of subclavian venous catheterization who can provide informed consent.

Not a fit: Patients who are moribund or have severe hemostasis disorders or unstable respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the success rate and safety of subclavian venous catheterization in critically ill patients.

How similar studies have performed: Preliminary results from similar studies using innovative devices have shown promise, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Nimes

• CHU de NIMES — Nimes, France (RECRUITING)

Study contacts

• Study coordinator: Jean-Yves LEFRANT, Pr .

Conditions: Ultrasound Guidance, Central Venous Catheterization, subclavian vein, needle-steering device