Standard Ultrasound Guidance vs. New Needle-steering Device in Subclavian Venous Catheterization (NEEDLEVISIO2)

Centre Hospitalier Universitaire de Nīmes

Status

Enrolling

Conditions

Ultrasound Guidance

Central Venous Catheterization

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06050902

NIMAO/2021-1/NB-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

124 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.