Comparison of Two Syringe-free In-plane Techniques in Ultrasound-guided Central Venous Catheterization

Study Overview
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Brief Summary
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Ultrasound guidance has become a standard for central venous catheterization. The aim of this study is to compare jugular venous catheterization by using lateral oblique approach to brachiocephalic catheterization by using Y-shape imaging. The trial is planned as prospective randomized and single-blind study. Eighty patients are planned to include in this study. Patients will be assigned to two groups: Oblique visualization Group (central catheter will be placed to the jugular vein by using ultrasound-guided in-plane syringe-free technique) and Y-shape visualization Group (central catheter will be placed to the brachiocephalic vein by using ultrasound-guided in-plane syringe-free technique). Two groups will be compared in terms of number of puncture attempts, procedural time, time of preprocedural ultrasound scanning, overall success rate, complications, the ease of the catheterization process and ultrasound visibility.

Detailed Description
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Central venous catheters are frequently placed in the operating rooms, intensive care units and emergency departments for various indications such as intravenous fluid, drug infusion, measurement of cardiac parameters and lack of vascular access. Ultrasound guidance has become a standard for central venous catheterization. The use of ultrasound has reduced the number of puncture attempts, increased success rate and reduced complications. While the central venous catheter is inserted by ultrasound, the vessels and the needle can be imaged in real-time. In plane and out-of-plane imaging techniques can be used during catheterization. The in-plane technique ensures the entire needle visualization in ultrasound images. With the linear ultrasound probe, the vessel and needle are imaged longitudinally in the in-plane technique. When an endocavity (micro-convex) ultrasound probe is used, three central vessels (jugular, subclavian and brachiocephalic veins) are displayed as Y-shape. The advantage of the endocavity (micro-convex) probe is that it can visualize deeper tissues and deep veins, and more tissues can be imaged in wider angle. Both techniques have been successfully applied in central catheter placement. In-plane technique also ensures syringe-free cannulation where blood aspiration with a syringe attached to the needle is not necessary. The aim of this study is to compare two different ultrasound guided in-plane techniques for central venous catheterization. The investigators planned to compare jugular venous catheterization using a linear probe and lateral oblique approach to brachiocephalic catheterization using a micro-convex probe and Y-shape imaging. The primary outcomes are number of puncture attempts, success rate at first attempt, overall success rate, procedure time, ultrasound scanning time and rate of complications. Secondary outcomes are visibility of the veins and the needle in ultrasound images. The trial is a comparison of two different interventional technique and planned as prospective randomized and single-blind study. Patients aged between 18-85 years that are planned central venous catheter placement will be included in the study. Patients included in the study will be assigned into two groups by computer-assisted randomization. In the first group (Oblique visualization Group), central catheter will be placed to the jugular vein by using ultrasound-guided in-plane syringe-free technique. In the second group (Y-shape visualization Group), central catheter will be placed to the brachiocephalic vein by using ultrasound-guided in-plane syringe-free technique Linear ultrasound probe will be used in the first group, and endocavity (micro-convex) ultrasound probe will be used in the second group. In both groups, the number of puncture attempts, the number of needle redirections, and the procedure time will be recorded. The time of preprocedural ultrasound scanning will be recorded in both groups. In addition, complications during the procedure such as bleeding, hemothorax, pneumothorax, hematoma and carotid vascular injury will be recorded. Overall success rates will be assessed in each group at the end of the study. A catheterization procedure will be considered as unsuccessful after third puncture attempt or more than 10 needle redirections are needed or requires a procedure time more than 3 minutes. At this moment, the catheter will be placed to a different region or the investigators will switch to a different approach. The ease of the catheterization process will be scored between 0 and 10 by the investigator performing the process (0: the hardest, 10: the easiest). The ultrasound visibility of the needle, vessels, guide wire and catheter will be scored between 0 and 4 (4: excellent view, 3: good view, 2: Medium, 1: difficult 0: impossible to image). The recorded data will be compared between the two groups.

Official Title
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Comparison of Two Syringe-free In-plane Techniques in Ultrasound-guided Central Venous Catheterization: Jugular Venous Catheterization With Oblique Approach and Brachiocephalic Catheterization Using Y-shape Image

Conditions
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Central Venous Catheter Placement

Intervention / Treatment
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* Procedure: Central venous catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that are planned a central venous catheter placement Exclusion Criteria: Morbid obese patients (body mass index> 40) People with severe coagulopathy Severe deformity at the neck Skin deformity or infection at catheterization site Congenital anomalies of central veins

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There will be two parallel groups in each a different central catheterization method will be performed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oblique visualization linear probe<br>A linear ultrasound probe will be utilized to place the central catheter into the jugular vein | Procedure: Central venous catheterization<br>* A standard 20 cm (adult-size) 3-port central catheter will be placed to the indicated patients by using standard Seldinger technique (with the assist of a guide wire) under ultrasound guidance<br>|
| Experimental: Y-shape visualization micro-convex probe<br>A micro-convex endocavity ultrasound probe will be utilized to place the central catheter into the brachiocephalic vein | Procedure: Central venous catheterization<br>* A standard 20 cm (adult-size) 3-port central catheter will be placed to the indicated patients by using standard Seldinger technique (with the assist of a guide wire) under ultrasound guidance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of puncture attempts | Number of needle insertions to the catheterization region for placing a catheter | During the whole cannulation procedure, starting from the 1st minute until the end of the procedure | 
| Cannulation procedural time | Duration of the whole cannulation procedure | From the 1st minute through withdrawal of the needle, up to 3 minutes | 
| Catheterization procedural time | Duration of the whole catheterization procedure | During the procedure, starting from the 1st minute through placement of the catheter; up to 3 minutes | 
| Number of needle redirections | Redirections of the needle towards the vessel | During the whole cannulation procedure, starting from the 1st minute through the procedure; assessed up to 3 minutes | 
| Success rate | Overall success rates of the procedures in each group | Through study completion, an average of 4 months | 
| Success rate at first attempt | Success rate at first attempt of the procedures in each group | Through study completion, an average of 4 months | 
| Complications | Rate of complications that occur during catheterization procedure | Through study completion, an average of 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vessel visualization | Visualization of the vessels in dynamic ultrasound images | Throughout the procedure; up to 3 minutes | 
| Needle visualization | Visualization of the needle in dynamic ultrasound images | Throughout the procedure; up to 3 minutes | 
| Guide-wire visualization | Visualization of the guide-wire in dynamic ultrasound images | Throughout the procedure; up to 3 minutes | 
| Catheter visualization | Visualization of the catheter in dynamic ultrasound images | At the end of catheterization procedure | 
| Ease of the catheterization process | A subjective score assigned by the operator on a scale with a minimum value of 0 and maximum value of 10. Higher scores mean a better outcome. | Throughout the procedure; up to 3 minutes | 
| Ultrasound time | The duration of pre-procedural ultrasound scanning | Throughout the pre-procedural ultrasonography; up to 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central venous catheter, Ultrasound, Jugular vein, Brachiocephalic vein, Endocavity micro-convex probe, Y-Shape