3D Guided Internal Jugular Vein Catheterization

Catheter Related Complication Clinical Trial

— 3D Givenchy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04683302
• Other study ID #: 3DJUG
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: October 2021
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter Related Complication
• Ultrasound; Complications

Intervention

Device:
• 3DUS biplanar catheterization
biplanar view of both short and long axis view of the internal jugular vein improves anatomical awareness and potentially improves safety of venous catheterization
• 2D US catheterization
2D short axis internal jugular vein catheterization

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis Eindhoven	Eindhoven	Noord-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Eindhoven University of Technology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first pass success	successful entry in internal jugular vein within one skin break and fluid motion	during procedure/surgery
Secondary	imaging time	time from placing USprobe until start needling (in seconds)	during procedure/surgery
Secondary	needling time	time from puncturing skin until access in vein (in seconds)	during procedure/surgery
Secondary	number of skin punctures	total skin breaks needed before successful entry in vein	during procedure/surgery
Secondary	number of needle withdrawals	redirections of needle >5mm without needing new skin breaks	during procedure/surgery
Secondary	number of posterior wall punctures	puncture of posterior wall of jugular vein	during procedure/surgery
Secondary	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
Secondary	needle visibility	visualization of needle during procedure on US screen, rating from good - adequate - poor	procedure/surgery