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

Central Venous Catheterization Clinical Trial

— NEEDLEVISIO2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050902
• Other study ID #: NIMAO/2021-1/NB-01
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Jean-Yves LEFRANT, Pr .
• Phone: +334.66.68.33.31
• Email: jean.yves.lefrant[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Venous Catheterization
• Ultrasound Guidance

Intervention

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

Locations

Country	Name	City	State
France	CHU de NIMES	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gender	Male/Female	Day 0
Other	Age	In years	Day 0
Other	Weight	In kilos	Day 0
Other	Height	In centimeters	Day 0
Other	Simplified Severity Index II score	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.	Hour 24
Other	Sequential Organ Failure Assessment score	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.	Day 0
Other	Puncture on right side ?	YES/NO	Day 0
Other	Patient unconscious ?	YES/NO (absence of contact and movement at the time of puncture)	Day 0
Other	Positive End Expiratory Pressure	In cm H²O	Day 0
Other	Indication for central venous catheter : Shock / vasopressor support	YES/NO	Day 0
Other	Indication for central venous catheter : nutrition	YES/NO	Day 0
Other	Indication for central venous catheter : Administration of venotoxic drugs	YES/NO	Day 0
Other	Indication for central venous catheter : Poor venous capital	YES/NO	Day 0
Other	Indication for central venous catheter : Vascular filling	YES/NO	Day 0
Other	Indication for central venous catheter : Repeated blood sampling	YES/NO	Day 0
Other	Indication for central venous catheter : Central venous pressure monitoring	YES/NO	Day 0
Primary	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	Day 0
Primary	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	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Hour 24
Secondary	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.	Day 0
Secondary	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.	Hour 24
Secondary	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.	Hour 24
Secondary	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	Hour 24
Secondary	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.	Hour 24
Secondary	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	Hour 24
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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).	Hour 24
Secondary	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).	Hour 24
Secondary	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.	Hour 24
Secondary	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.	Hour 24
Secondary	G. Time taken from first skin puncture to successful catheter insertion: Control group	In seconds	Day 0
Secondary	G. Time taken from first skin puncture to successful catheter insertion: Experimental group	In seconds	Day 0
Secondary	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).	Day 0
Secondary	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).	Day 0