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

Last updated: April 23, 2024
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Subclavian venipuncture for catheter placement using the needle-steering device

Clinical Study ID

NCT06050902
NIMAO/2021-1/NB-01
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any resuscitation patient requiring subclavian venous catheterization.
  • Patients or representatives must have given free, informed consent and signed theconsent 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

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 ofbarotrauma
  • Patients for whom it is difficult to visualize the subclavian veins bilaterally (leftand right) during ultrasound pre-screening
  • Patients with a malformation/deformity of the subclavian region (congenital oracquired: 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 centralvenous line placement.
  • Patients under court protection, guardianship or curatorship.
  • Pregnant, parturient or breastfeeding women.

Study Design

Total Participants: 124
Treatment Group(s): 1
Primary Treatment: Subclavian venipuncture for catheter placement using the needle-steering device
Phase:
Study Start date:
January 16, 2024
Estimated Completion Date:
August 01, 2025

Study 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.

Connect with a study center

  • CHU de NIMES

    Nimes, 30029
    France

    Active - Recruiting

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