Standard Ultrasound Guidance vs. New Needle-steering Device in Subclavian Venous Catheterization

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Sep 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device that helps guide a needle for placing a central venous catheter in the subclavian vein, which is located just below the collarbone. This procedure is often necessary for patients in intensive care units (ICUs) who need quick access to their bloodstream. The trial aims to find out if this new needle-steering device makes it easier and faster for medical staff to successfully place the catheter compared to the standard ultrasound guidance method currently used.

To participate in this trial, patients must be adults (18 years and older) who need a subclavian venous catheter for their treatment. They should also be able to give consent, either themselves or through a representative, especially in emergency situations. However, certain patients may not be eligible, such as those with serious health issues that affect their blood or breathing. If chosen to participate, patients can expect to be part of a study that could help improve the way this important procedure is done in the future.

Gender

ALL

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.