Dynamic SAX vs Conventional LAX in Internal Jugular Vein Catheterization

NCT03841968 | Completed

• 1 other identifier: DNTP IJV
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

Conventionally, short-axis out-of-plane (SAX) or long-axis in-plane (LAX) ultrasound views are commonly used to guide internal jugular vein catheterization. SAX dynamic needle tip positioning (SAX-DNTP) is a novel ultrasound imaging technique that enables continuous visualization of the needle tip during ultrasound-guided cannulation; When the needle tip is imaged as a hyperechoic dot, the ultrasound probe is moved a few millimeters, and then the needle is advanced until the needle tip reappears in the vessel lumen. The process is repeated until the needle is advanced more than 1 cm into the lumen. The catheter is then introduced into the vessel. The aim of this study was to compare the first pass success rate of internal jugular vein catheterization between SAX-DNTP and the conventional LAX technique.

Conditions

Cardiac Surgical Procedures; Central Venous Catheterization; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• First pass success rate of the internal jugular vein catheterization_confirmation of the central venous pressure through a patient monitor

  First pass success rate of the internal jugular vein catheterization\_confirmation of the central venous pressure through a patient monitor

  Intraoperative

Secondary Outcomes (2)

• Total procedure time

  Intraoperative

• Rate of posterior wall puncture_assessed by ultrasound

  Intraoperative

Study Arms (2)

Dynamic needle tip positioning

ACTIVE COMPARATOR

Dynamic needle tip positioning

Procedure: Dynamic needle tip positioning under ultrasound-guidance

Conventional long-axis

ACTIVE COMPARATOR

Conventional long-axis

Procedure: Conventional long-axis view

Interventions

Dynamic needle tip positioning under ultrasound-guidance PROCEDURE

The tip of needle is positioned under ultrasound-guidance using dynamic short-axis view.

Dynamic needle tip positioning

Conventional long-axis view PROCEDURE

The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.

Conventional long-axis

Eligibility Criteria

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

You may qualify if:

• Elective cardiac surgery where central venous catheterization is required.

You may not qualify if:

• skin infection or trauma
• Shock
• Patients on ECMO or IABP support
• Morbid obesity
• Profound coagulopathy

Sponsors & Collaborators

• Seoul National University Hospital: lead
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: March 11, 2019
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: February 28, 2020

Record last verified: 2019-02

Locations

KR (1)