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Completed

NCT Number: NCT06050902

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

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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Key information

Conditions

Ultrasound Guidance Central Venous Catheterization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de NIMES

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Subclavian venipuncture for catheter placement using the needle-steering device

Device
  • Navigation software is implemented in an ultrasound machine.
  • A linear ultrasound probe (similar in appearance to a standard ultrasound probe) is used
  • Magnetization of the puncture needle after short introduction of the needle in a dedicated device.
  • Real time needle guidance on the ultrasound screen during the puncture.

Primary outcomes

  1. Successful catheter insertion at first skin puncture: Control group

    Time frame: Day 0

    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

  2. Successful catheter insertion at first skin puncture: Experimental group

    Time frame: Day 0

    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

Secondary outcomes

  1. A. Number of skin punctures required before successful central venous catheterism: Control group

    Time frame: Day 0

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

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

    Time frame: Day 0

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

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

    Time frame: Day 0

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

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

    Time frame: Hour 24

    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.

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

    Time frame: Day 0

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

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

    Time frame: Hour 24

    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.

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

    Time frame: Hour 24

    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.

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

    Time frame: Hour 24

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

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

    Time frame: Hour 24

    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.

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

    Time frame: Hour 24

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

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

    Time frame: Day 0

    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.

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

    Time frame: Day 0

    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.

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

    Time frame: Hour 24

    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).

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

    Time frame: Hour 24

    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).

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

    Time frame: Hour 24

    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.

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

    Time frame: Hour 24

    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.

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

    Time frame: Day 0

    In seconds

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

    Time frame: Day 0

    In seconds

  19. H. Failure rate: Control group

    Time frame: Day 0

    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).

  20. H. Failure rate: Experimental group

    Time frame: Day 0

    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).

Other outcomes

  1. Gender

    Time frame: Day 0

    Male/Female

  2. Age

    Time frame: Day 0

    In years

  3. Weight

    Time frame: Day 0

    In kilos

  4. Height

    Time frame: Day 0

    In centimeters

  5. Simplified Severity Index II score

    Time frame: Hour 24

    The SSI II score ( Simplified Severity Index II) is a score used to assess a patient's severity, and is one of the scores used in intensive care and resuscitation. The parameters to be taken into account are the most severe ones collected during the 24 hours following admission to intensive care.

  6. Sequential Organ Failure Assessment score

    Time frame: Day 0

    The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category.

  7. Puncture on right side ?

    Time frame: Day 0

    YES/NO

  8. Patient unconscious ?

    Time frame: Day 0

    YES/NO (absence of contact and movement at the time of puncture)

  9. Positive End Expiratory Pressure

    Time frame: Day 0

    In cm H²O

  10. Indication for central venous catheter : Shock / vasopressor support

    Time frame: Day 0

    YES/NO

  11. Indication for central venous catheter : nutrition

    Time frame: Day 0

    YES/NO

  12. Indication for central venous catheter : Administration of venotoxic drugs

    Time frame: Day 0

    YES/NO

  13. Indication for central venous catheter : Poor venous capital

    Time frame: Day 0

    YES/NO

  14. Indication for central venous catheter : Vascular filling

    Time frame: Day 0

    YES/NO

  15. Indication for central venous catheter : Repeated blood sampling

    Time frame: Day 0

    YES/NO

  16. Indication for central venous catheter : Central venous pressure monitoring

    Time frame: Day 0

    YES/NO

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: NEEDLEVISIO2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2023
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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