3D Guided Internal Jugular Vein Catheterization

Not Applicable

Completed

• Conditions: Ultrasound; Complications; Catheter Related Complication
• Interventions: Device: 2D US catheterization; Device: 3DUS biplanar catheterization

• Registration Number: NCT04683302
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-24
• Study Start: 2021-03-15
• Primary Completion: 2021-08-15
• Study Completion: 2021-09-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	2D US catheterization	conventional 2D guided internal jugular vein catheterization
intervention	3DUS biplanar catheterization	3D biplanar guided internal jugular vein catheterization

Primary Outcome Measures

Name	Time	Method
first pass success	during procedure/surgery	successful entry in internal jugular vein within one skin break and fluid motion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Catharina Ziekenhuis Eindhoven; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands