Dynamic SAX vs Conventional LAX in Internal Jugular Vein Catheterization

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03841968

Collaborator

SMG-SNU Boramae Medical Center (Other)

146

Enrollment

Location

Arms

Actual Duration (Months)

16.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgical Procedures Central Venous Catheterization Ultrasonography	Procedure: Dynamic needle tip positioning under ultrasound-guidance Procedure: Conventional long-axis view	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

146 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Randomized Trial of Ultrasound-guided Right Internal Jugular Vein Catheterization Using Dynamic Short Axis Versus Conventional Long-axis View in Cardiac Surgery Patients: a Dual-center Randomized Trial

Actual Study Start Date :

Mar 11, 2019

Actual Primary Completion Date :

Dec 9, 2019

Actual Study Completion Date :

Dec 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dynamic needle tip positioning Dynamic needle tip positioning	Procedure: Dynamic needle tip positioning under ultrasound-guidance The tip of needle is positioned under ultrasound-guidance using dynamic short-axis view.
Active Comparator: Conventional long-axis Conventional long-axis	Procedure: Conventional long-axis view The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.

Arm

Intervention/Treatment

Active Comparator: Dynamic needle tip positioning

Dynamic needle tip positioning

Procedure: Dynamic needle tip positioning under ultrasound-guidance

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

Active Comparator: Conventional long-axis

Conventional long-axis

Procedure: Conventional long-axis view

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Total procedure time [Intraoperative]
Total procedure time
Rate of posterior wall puncture_assessed by ultrasound [Intraoperative]
Rate of posterior wall puncture_assessed by ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Elective cardiac surgery where central venous catheterization is required.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital
SMG-SNU Boramae Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT03841968

Other Study ID Numbers:

DNTP IJV

First Posted:

Feb 15, 2019

Last Update Posted:

Feb 28, 2020

Last Verified:

Feb 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 28, 2020