3D Guided Internal Jugular Vein Catheterization

Study Overview
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Brief Summary
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Central venous catheterization through the jugular vein is a standard procedure for cardiothoracic surgical patients. Ultrasound (US) guidance is preferred and compared to traditional landmark approach decreases complications and increases success rate. Both long and short axis views are used for obtaining access, both with their own advantages and shortcomings. Complications have also not completely diminished with the use of US. The investigators propose a new technique using 3D biplanar imaging, combining advantages from both long and short axis views in one image, enabling more successful procedures and a lower complication rate

Detailed Description
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Central venous catheters (CVC) are frequently placed in patients who are scheduled for cardiothoracic surgery (ICU). Ultrasound (US) guidance has consistently shown to not only improve success rate of procedures, but also to decrease complications with most benefit for the jugular vein. However, serious adverse events still occur despite US guidance Conventional two dimensional ultrasound (2D US) guided access if performed in either the short axis or long axis view, with both approaches having their own limitations. Using short axis view, the operator is never certain of the position of the needle tip as the shaft of the needle is not distinguishable from the tip in this view. Structures not (yet) visible in the US screen can already be punctured, or a vessel can be entered at a different position than preferred. A possible mechanism through which carotid artery puncture can happen is the posterior wall puncture4. For long axis view, with proper technique the needle is viewed entirely during the procedure. However, this requires extensive experience and the overview of surrounding structures is lost.Multiple attempts at improving US guided venous access have been tried, such as oblique visualization or alternating short and long axis views but those approaches still have their shortcomings. Three dimensional ultrasound (3D US) has a theoretical advantage of increased anatomical awareness, but evidence of improvement in needle based procedures is scarce. Recently, a new 3D US probe is introduced which can address the above mentioned limitations of 2D US for access procedures. The investigators hypothesize that this superior three dimensional awareness can improve needle placement during central venous catheterization, increasing success rates and potentially decreasing complications.

Official Title
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3D Biplane vs Conventional 2D Ultrasound Guided Internal Jugular VEin caNnulation in CardiotHoracic surgerY Patients

Conditions
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Catheter Related Complication, Ultrasound; Complications

Intervention / Treatment
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* Device: 3DUS biplanar catheterization
* Device: 2D US catheterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective cardiothoracic surgery with need for central venous catheter placement written informed consent Exclusion Criteria: no informed consent other site for central line placement (eg subclavian vein) emergency surgery

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized clinical trial (RCT)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>conventional 2D guided internal jugular vein catheterization | Device: 2D US catheterization<br>* 2D short axis internal jugular vein catheterization<br>|
| Experimental: intervention<br>3D biplanar guided internal jugular vein catheterization | Device: 3DUS biplanar catheterization<br>* biplanar view of both short and long axis view of the internal jugular vein improves anatomical awareness and potentially improves safety of venous catheterization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first pass success | successful entry in internal jugular vein within one skin break and fluid motion | during procedure/surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| imaging time | time from placing USprobe until start needling (in seconds) | during procedure/surgery | 
| needling time | time from puncturing skin until access in vein (in seconds) | during procedure/surgery | 
| number of skin punctures | total skin breaks needed before successful entry in vein | during procedure/surgery | 
| number of needle withdrawals | redirections of needle >5mm without needing new skin breaks | during procedure/surgery | 
| number of posterior wall punctures | puncture of posterior wall of jugular vein | during procedure/surgery | 
| operator satisfaction | satisfaction of operator with visual feedback from US, rated on Likert Scale 1-5 with 1 no satisfaction at all and 5 totally satisfied | procedure/surgery | 
| needle visibility | visualization of needle during procedure on US screen, rating from good - adequate - poor | procedure/surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound, internal jugular vein, cardiothoracic surgery