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COMPLETED
NCT06050902
NA

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

Sponsor: Centre Hospitalier Universitaire de Nīmes

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-01-16

Completion Date

2025-12-26

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

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.

Locations (1)

CHU de NIMES

Nîmes, France