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

NCT06050902 | Completed

• 1 other identifier: NIMAO/2021-1/NB-01
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Central Venous Catheterization; Ultrasound Guidance

Keywords

subclavian vein; needle-steering device

Outcome Measures

Primary Outcomes (2)

• Successful catheter insertion at first skin puncture: Control group

  The main objective is to compare the success rate of subclavian venous cannulation at first puncture between the conventional ultrasound guidance technique and ultrasound guidance assisted by a needle-steering device. Successful subclavian venous cannulation (success is defined as catheter insertion at first skin puncture). YES/NO

  Day 0

• Successful catheter insertion at first skin puncture: Experimental group

  The main objective is to compare the success rate of subclavian venous cannulation at first puncture between the conventional ultrasound guidance technique and ultrasound guidance assisted by a needle-steering device. Successful subclavian venous cannulation (success is defined as catheter insertion at first skin puncture). YES/NO

  Day 0

Secondary Outcomes (20)

• A. Number of skin punctures required before successful central venous catheterism: Control group

  Day 0

• A. Number of skin punctures required before successful central venous catheterism: Experimental group

  Day 0

• B. Complication rate. All causes, composite score: Control group

  Day 0

• B. Complication rate. All causes, composite score: Control group

  Hour 24

• B. Complication rate. All causes, composite score: Experimental group

  Day 0

Other Outcomes (16)

• Gender

  Day 0

• Age

  Day 0

• Weight

  Day 0

Study Arms (2)

Standard ultrasound guidance for subclavian venipuncture

NO INTERVENTION

62 patients undergoing the usual standard ultrasound guidance technique for subclavian venipuncture

Subclavian venipuncture using the needle-steering device

EXPERIMENTAL

62 patients undergoing subclavian venipuncture using the needle-steering device

Device: Subclavian venipuncture for catheter placement using the needle-steering device

Interventions

Subclavian venipuncture for catheter placement using the needle-steering device 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.

Subclavian venipuncture using the needle-steering device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de NIMES

Nîmes, 30029, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be blinded to his or her assignment group. The primary endpoint and secondary endpoints A, D, G, H, will be collected by an assessor independent from the operator, during the central venous catheterization procedure. This assessor will not be blinded to the technique used.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, patient- and evaluator-blinded, controlled superiority trial comparing standard ultrasound guidance and a new needle-steering device.

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 22, 2023
• Study Start: January 16, 2024
• Primary Completion: December 26, 2025
• Study Completion: December 26, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

FR (1)