3D Guided Internal Jugular Vein Catheterization

NCT04683302 | Completed FDA Device

• 1 other identifier: 3DJUG
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Conditions

Catheter Related Complication; Ultrasound; Complications

Keywords

ultrasound; internal jugular vein; cardiothoracic surgery

Outcome Measures

Primary Outcomes (1)

• first pass success

  successful entry in internal jugular vein within one skin break and fluid motion

  during procedure/surgery

Secondary Outcomes (7)

• imaging time

  during procedure/surgery

• needling time

  during procedure/surgery

• number of skin punctures

  during procedure/surgery

• number of needle withdrawals

  during procedure/surgery

• number of posterior wall punctures

  during procedure/surgery

Study Arms (2)

control

ACTIVE COMPARATOR

conventional 2D guided internal jugular vein catheterization

Device: 2D US catheterization

intervention

EXPERIMENTAL

3D biplanar guided internal jugular vein catheterization

Device: 3DUS biplanar catheterization

Interventions

3DUS biplanar catheterization DEVICE

biplanar view of both short and long axis view of the internal jugular vein improves anatomical awareness and potentially improves safety of venous catheterization

intervention

2D US catheterization DEVICE

2D short axis internal jugular vein catheterization

control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective cardiothoracic surgery with need for central venous catheter placement
• written informed consent

You may not qualify if:

• no informed consent
• other site for central line placement (eg subclavian vein)
• emergency surgery

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Eindhoven University of Technology: collaborator

Study Sites (1)

Catharina Ziekenhuis Eindhoven

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 34807306 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: coded (e)crf's and anonymized and coded ultrasound clips
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: randomized clinical trial (RCT)

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 24, 2020
• Study Start: March 15, 2021
• Primary Completion: August 15, 2021
• Study Completion: September 15, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)