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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
124
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.
CHU de NIMES
Nîmes, France
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
Time frame: Day 0
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
Time frame: Day 0
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.
Time frame: Day 0
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.
Time frame: Day 0
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.
Time frame: Day 0
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.
Time frame: Hour 24
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.
Time frame: Day 0
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.
Time frame: Hour 24
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.
Time frame: Hour 24
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
Time frame: Hour 24
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.
Time frame: Hour 24
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
Time frame: Hour 24
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.
Time frame: Day 0
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.
Time frame: Day 0
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).
Time frame: Hour 24
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).
Time frame: Hour 24
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.
Time frame: Hour 24
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.
Time frame: Hour 24
G. Time taken from first skin puncture to successful catheter insertion: Control group
In seconds
Time frame: Day 0
G. Time taken from first skin puncture to successful catheter insertion: Experimental group
In seconds
Time frame: Day 0
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).
Time frame: Day 0
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).
Time frame: Day 0
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.