Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT04683302
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2020-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
3D Guided Internal Jugular Vein Catheterization
Sponsor:
Catharina Ziekenhuis Eindhoven
Organization:
Study Overview
Official Title:
3D Biplane vs Conventional 2D Ultrasound Guided Internal Jugular VEin caNnulation in CardiotHoracic surgerY Patients
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3D Givenchy
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: