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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-16

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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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

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Ultrasound Guidance Central Venous Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Standard ultrasound guidance for subclavian venipuncture

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Subclavian venipuncture using the needle-steering device

62 patients undergoing subclavian venipuncture using the needle-steering device

Group Type EXPERIMENTAL

Subclavian venipuncture for catheter placement using the needle-steering device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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).

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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No