NCT06050902

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Central venous catheterization is required in up to two-thirds of intensive care unit patients. Ultrasound-guided placement is now recommended over the "blind" technique to decrease the risk of mechanical complications and duration of the procedure. Although the subclavian site is recommended as first-line because of a lower risk of catheter-related infection and thrombosis (than with internal jugular and femoral sites), this approach is underused (\< 20% of regular users). There is also a very low use of ultrasound guidance for subclavian catheterization (\< 30% of cases), due to technical difficulties such as more complex visualization of the needle. New magnetic devices theoretically allow better visualization of the needle, a higher success rate and a lower complication rate. In this context, the team performed a prospective randomized simulation trial on a phantom ("reduced torso model"), comparing the standard ultrasound guidance technique with an ultrasound-guided technique assisted by a new needle-steering device in subclavian central venous catheterization (study in progress). The results of this study 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). These preliminary results argue for a clinical trial of the practical performance of this new device in intensive care unit patients. The hypothesis is that the needle-steering device will result in a higher success rate of subclavian venous cannulation at first puncture compared with the conventional ultrasound guidance technique.

Conditions

• Ultrasound Guidance
• Central Venous Catheterization

Interventions

Type	Name	Description
DEVICE	Subclavian venipuncture for catheter placement using the needle-steering device	1. Navigation software is implemented in an ultrasound machine. 2. A linear ultrasound probe (similar in appearance to a standard ultrasound probe) is used 3. Magnetization of the puncture needle after short introduction of the needle in a dedicated device. 4. Real time needle guidance on the ultrasound screen during the puncture.

Timeline

• Start date: 2024-01-16
• Primary completion: 2025-12-26
• Completion: 2025-12-26
• First posted: 2023-09-22
• Last updated: 2026-02-11

Locations

1 site across 1 country: France