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Ultrasound GuidanceNEEDLEVISIO2NCT06050902

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

A study testing Subclavian venipuncture for catheter placement using the needle-steering device in people with Ultrasound Guidance and Central Venous Catheterization, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Subclavian venipuncture for catheter placement using the needle-steering device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteFrance
Study dates
16 Jan 2024to 26 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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)
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU de NIMES

    Nîmes, 30029

Other trials in France

About this study

Official title: Ultrasound-guided Subclavian Venous Catheterization. A Randomized, Single-blind, Controlled Superiority Trial Comparing Standard Ultrasound Guidance and a New Needle-steering Device

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.

Read the 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.

Being tested
Subclavian venipuncture for catheter placement using the needle-steering device
Keywords
subclavian vein, needle-steering device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subclavian venipuncture for catheter placement using the needle-steering deviceDevice

    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.
Study groups in NCT06050902
Study groupRoleWhat they receive
Standard ultrasound guidance for subclavian venipunctureNo intervention62 patients undergoing the usual standard ultrasound guidance technique for subclavian venipuncture
Subclavian venipuncture using the needle-steering deviceExperimental62 patients undergoing subclavian venipuncture using the needle-steering device
Receives: Device: Subclavian venipuncture for catheter placement using the needle-steering device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 0

  2. 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

    Measured: Day 0

Secondary outcomes (20)
  1. A. Number of skin punctures required before successful central venous catheterism: Control group

    Median number of skin punctures required before successful central venous catheterism. Success is defined as catheter insertion.

    Measured: Day 0

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

    Median number of skin punctures required before successful central venous catheterism. Success is defined as catheter insertion.

    Measured: Day 0

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

    Onset of at least one complication due to venous puncture. Complications including pneumothorax, arterial puncture, hematoma, malpositioning or puncture failure will all be recorded.

    Measured: Day 0

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

    Onset of at least one complication within 24 of venous puncture. Complications including pneumothorax, arterial puncture, hematoma, malpositioning or puncture failure will all be recorded.

    Measured: Hour 24

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

    Onset of at least one complication due to venous puncture. Complications including pneumothorax, arterial puncture, hematoma, malpositioning or puncture failure will all be recorded.

    Measured: Day 0

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

    Onset of at least one complication within 24 of venous puncture. Complications including pneumothorax, arterial puncture, hematoma, malpositioning or puncture failure will all be recorded.

    Measured: Hour 24

  7. C. Pneumothorax within 24 hours of venous puncture: Control group

    Data collection using a standardized online electronic Case Report Form. Clinical history + frontal chest X-rays taken within one hour of puncture AND at H12-24 +/- ultrasound or computed tomography scan according to clinical or diagnostic doubt (examinations carried out at the discretion of the physicians).

    The number and percentage of patients with pneumothorax will be recorded.

    Measured: Hour 24

  8. C bis. Drainage required for pneumothorax within 24 hours of venous puncture: Control group

    Data collection using a standardized online electronic Case Report Form. YES/NO

    Measured: Hour 24

  9. C. Pneumothorax within 24 hours of venous puncture: Experimental group

    Data collection using a standardized online electronic Case Report Form Clinical history + frontal chest X-rays taken within one hour of puncture AND at 12-24 hours +/- ultrasound or computed tomography scan according to clinical or diagnostic doubt (examinations carried out at the discretion of the physicians).

    The number and percentage of patients with pneumothorax will be recorded.

    Measured: Hour 24

  10. C bis. Drainage required for pneumothorax within 24 hours of venous puncture: Experimental group

    Data collection using a standardized online electronic Case Report Form YES/NO

    Measured: Hour 24

  11. D. Arterial puncture within 24 hours of venous puncture: Control group

    YES / NO Data collection using a standardized online electronic Case Report Form. Any arterial punctures during the procedure will be recorded in numbers and percentages by an independent investigator, present during the procedure and therefore aware of technique used.

    Measured: Day 0

  12. D. Arterial puncture within 24 hours of venous puncture: Experimental group

    YES / NO Data collection using a standardized online electronic Case Report Form. Any arterial punctures during the procedure will be recorded in numbers and percentages by an independent investigator, present during the procedure and therefore aware of technique used.

    Measured: Day 0

  13. E. Hematoma or hemorrhage Grade 3 or over within 24 hours of venous puncture: Control group

    YES / NO. Data collection using a standardized online electronic Case Report Form.

    Clinical history + frontal chest X-rays taken within one hour of puncture AND at H12-24 +/- ultrasound or CT scan according to clinical point of call or diagnostic doubt (examinations carried out according to the choice of the department's physicians).

    Within 24 hours, occurrence of hematoma or hemorrhage grade ≥ 3 (specify whether a therapeutic intervention is required - according to the definition below - or transfusion for intrathoracic bleeding). The occurrence of grade ≥ 3 hematoma or hemorrhage will be established according to the definition of "Common Terminology Criteria for Adverse Events (CTCAE) v5.0": indication for transfusion or invasive intervention (grade 3), need for urgent intervention or alteration of vital prognosis (grade 4), or death (grade 5).

    Measured: Hour 24

  14. E. Hematoma or hemorrhage Grade 3 or over within 24 hours of venous puncture: Experimental group

    YES / NO. Data collection using a standardized online electronic Case Report Form .

    Clinical history + frontal chest X-rays taken within one hour of puncture AND at H12-24 +/- ultrasound or CT scan according to clinical point of call or diagnostic doubt (examinations carried out according to the choice of the department's physicians).

    Within 24 hours, occurrence of hematoma or hemorrhage grade ≥ 3 (specify whether a therapeutic intervention is required - according to the definition below - or transfusion for intrathoracic bleeding). The occurrence of grade ≥ 3 hematoma or hemorrhage will be established according to the definition of "Common Terminology Criteria for Adverse Events (CTCAE) v5.0": indication for transfusion or invasive intervention (grade 3), need for urgent intervention or alteration of vital prognosis (grade 4), or death (grade 5).

    Measured: Hour 24

  15. F. Malpositioned catheter seen on the X-ray within 1 hour of venous puncture: Control group

    YES / NO. Data collection using a standardized online electronic Case Report Form .

    Front thoracic radiograph (systematically within one hour of puncture) puncture): "Sweet Spot" technique (approximation of the atriocaval junction, a rectangle in which the position of the lower end of the central venous line: between the lower third of the superior vena cava and the inferior lower edge of the right atrium (located by the cardiophrenic angle). Malpositioning will be recorded as numbers and percentages.

    Measured: Hour 24

  16. F. Malpositioned catheter seen on the X-ray within 1 hour of venous puncture: Experimental group

    YES / NO. Data collection using a standardized online electronic Case Report Form.

    Front thoracic radiograph (systematically within one hour of puncture) puncture): "Sweet Spot" technique (approximation of the atriocaval junction, a rectangle in which the position of the lower end of the central venous line: between the lower third of the superior vena cava and the inferior lower edge of the right atrium (located by the cardiophrenic angle). Malpositioning will be recorded as numbers and percentages.

    Measured: Hour 24

  17. G. Time taken from first skin puncture to successful catheter insertion: Control group

    In seconds

    Measured: Day 0

  18. G. Time taken from first skin puncture to successful catheter insertion: Experimental group

    In seconds

    Measured: Day 0

  19. H. Failure rate: Control group

    Percentage of failures. After three failed punctures, the technique is considered as a failure. Data collection using a standardized online electronic Case Report Form.

    The number of skin punctures will be counted. The criterion "failure" will be retained after 3 unsuccessful skin punctures.

    This requires a change of insertion site and withdrawal from the study. The other complication criteria mentioned above will still be recorded and analyzed but the time will not be collected (criterion G).

    Measured: Day 0

  20. H. Failure rate: Experimental group

    Percentage of failures. After three failed punctures, the technique is considered as a failure.Percentage of failures. After three failed punctures, the technique is considered as a failure. Data collection using a standardized online electronic Case Report Form.

    The number of skin punctures will be counted. The criterion "failure" will be retained after 3 unsuccessful skin punctures.

    This requires a change of insertion site and withdrawal from the study. The other complication criteria mentioned above will still be recorded and analyzed but the time will not be collected (criterion G).

    Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2023
  2. Study start16 Jan 2024
  3. Primary completion26 Dec 2025
  4. Study completion26 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, patient- and evaluator-blinded, controlled superiority trial comparing standard ultrasound guidance and a new needle-steering device.
Masking
Single blind
Who is masked
Participant
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06050902
Sponsor's protocol ID
NIMAO/2021-1/NB-01
Acronym
NEEDLEVISIO2
Status last verified
Feb 2026
First submitted
5 Sep 2023
Last updated
8 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The analysis of the data will be carried out by the BESPIM service of the CHU of Nîmes. Within one year after the end of the research or its interruption, a final report will be established and signed by the sponsor and the investigator. This report will be made available to the competent authority. The sponsor will transmit the results of the research in the form of a summary of the final report to the CPP (Comité de Protection des Personnes) and, if necessary, to the ANSM within one year after the end of the research.

Publications

  • Boulet N, Muller L, Guillermou H, Chevallier T, Saadi L, Lancry T, Martiniere H, Lefrant JY, Roger C. Infraclavicular subclavian vein catheterisation: a randomised controlled trial comparing standard ultrasound guidance and a new needle guidance device. Anaesth Crit Care Pain Med. 2026 Jul 3:101888. doi: 10.1016/j.accpm.2026.101888. Online ahead of print.

    PubMed 42398765

Questions about this trial

What is this clinical trial studying?

A study testing Subclavian venipuncture for catheter placement using the needle-steering device in people with Ultrasound Guidance and Central Venous Catheterization, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful catheter insertion at first skin puncture: Control group (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06050902, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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