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

NCT06050902 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2026-02-11

No results posted yet for this study

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.

Conditions

  • Ultrasound Guidance
  • Central Venous Catheterization

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-16
Primary Completion
2025-12-26
Completion
2025-12-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06050902 on ClinicalTrials.gov