Clinical trial NCT06050902: Standard Ultrasound Guidance vs. New Needle-steering Device in Subclavian Venous Catheterization
Official title: Ultrasound-guided Subclavian Venous Catheterization. A Randomized, Single-blind, Controlled Superiority Trial Comparing Standard Ultrasound Guidance and a New Needle-steering Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ultrasound Guidance
Central Venous Catheterization
Keywords: subclavian vein
needle-steering device
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, patient- and evaluator-blinded, controlled superiority trial comparing standard ultrasound guidance and a new needle-steering device.
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful catheter insertion at first skin puncture: Control group
timeFrame: Day 0
measure: Successful catheter insertion at first skin puncture: Experimental group
timeFrame: Day 0
Secondary outcomes:
measure: A. Number of skin punctures required before successful central venous catheterism: Control group
timeFrame: Day 0
measure: A. Number of skin punctures required before successful central venous catheterism: Experimental group
timeFrame: Day 0
measure: B. Complication rate. All causes, composite score: Control group
timeFrame: Day 0
measure: B. Complication rate. All causes, composite score: Control group
timeFrame: Hour 24
measure: B. Complication rate. All causes, composite score: Experimental group
timeFrame: Day 0
measure: B. Complication rate. All causes, composite score: Experimental group
timeFrame: Hour 24
measure: C. Pneumothorax within 24 hours of venous puncture: Control group
timeFrame: Hour 24
measure: C bis. Drainage required for pneumothorax within 24 hours of venous puncture: Control group
timeFrame: Hour 24
measure: C. Pneumothorax within 24 hours of venous puncture: Experimental group
timeFrame: Hour 24
measure: C bis. Drainage required for pneumothorax within 24 hours of venous puncture: Experimental group
timeFrame: Hour 24
measure: D. Arterial puncture within 24 hours of venous puncture: Control group
timeFrame: Day 0
measure: D. Arterial puncture within 24 hours of venous puncture: Experimental group
timeFrame: Day 0
measure: E. Hematoma or hemorrhage Grade 3 or over within 24 hours of venous puncture: Control group
timeFrame: Hour 24
measure: E. Hematoma or hemorrhage Grade 3 or over within 24 hours of venous puncture: Experimental group
timeFrame: Hour 24
measure: F. Malpositioned catheter seen on the X-ray within 1 hour of venous puncture: Control group
timeFrame: Hour 24
measure: F. Malpositioned catheter seen on the X-ray within 1 hour of venous puncture: Experimental group
timeFrame: Hour 24
measure: G. Time taken from first skin puncture to successful catheter insertion: Control group
timeFrame: Day 0
measure: G. Time taken from first skin puncture to successful catheter insertion: Experimental group
timeFrame: Day 0
measure: H. Failure rate: Control group
timeFrame: Day 0
measure: H. Failure rate: Experimental group
timeFrame: Day 0
Other outcomes:
measure: Gender
timeFrame: Day 0
measure: Age
timeFrame: Day 0
measure: Weight
timeFrame: Day 0
measure: Height
timeFrame: Day 0
measure: Simplified Severity Index II score
timeFrame: Hour 24
measure: Sequential Organ Failure Assessment score
timeFrame: Day 0
measure: Puncture on right side ?
timeFrame: Day 0
measure: Patient unconscious ?
timeFrame: Day 0
measure: Positive End Expiratory Pressure
timeFrame: Day 0
measure: Indication for central venous catheter : Shock / vasopressor support
timeFrame: Day 0
measure: Indication for central venous catheter : nutrition
timeFrame: Day 0
measure: Indication for central venous catheter : Administration of venotoxic drugs
timeFrame: Day 0
measure: Indication for central venous catheter : Poor venous capital
timeFrame: Day 0
measure: Indication for central venous catheter : Vascular filling
timeFrame: Day 0
measure: Indication for central venous catheter : Repeated blood sampling
timeFrame: Day 0
measure: Indication for central venous catheter : Central venous pressure monitoring
timeFrame: Day 0
Locations:
city: Nimes
country: France
facility: CHU de NIMES
Study officials:
References: