Clinical trial NCT04683302: 3D Guided Internal Jugular Vein Catheterization
Official title: 3D Biplane vs Conventional 2D Ultrasound Guided Internal Jugular VEin caNnulation in CardiotHoracic surgerY Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Related Complication
Ultrasound; Complications
Keywords: ultrasound
internal jugular vein
cardiothoracic surgery
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Eindhoven University of Technology
First posted: 2020-12-24
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinical trial (RCT)
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: first pass success
timeFrame: during procedure/surgery
Secondary outcomes:
measure: imaging time
timeFrame: during procedure/surgery
measure: needling time
timeFrame: during procedure/surgery
measure: number of skin punctures
timeFrame: during procedure/surgery
measure: number of needle withdrawals
timeFrame: during procedure/surgery
measure: number of posterior wall punctures
timeFrame: during procedure/surgery
measure: operator satisfaction
timeFrame: procedure/surgery
measure: needle visibility
timeFrame: procedure/surgery
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis Eindhoven
state: Noord-Brabant
Study officials:
References:
citation: Scholten HJ, Meesters MI, Montenij LJ, Korsten EHM, Bouwman RA; 3DUI Study group. 3D biplane versus conventional 2D ultrasound imaging for internal jugular vein cannulation. Intensive Care Med. 2022 Feb;48(2):236-237. doi: 10.1007/s00134-021-06579-9. Epub 2021 Nov 22. No abstract available.