Adequate Insertion Depth of Dilator During Central Venous Catheterization

Adequate Insertion Depth of Dilator During Central Venous Catheterization Through the Right Internal Jugular Vein

For safe central catheterization, clinicians must be aware of adequate dilator insertion depth not to directly dilate the venous wall. The purpose of the study is to find out adequate insertion depth of the dilator during central venous catheterization through the internal jugular vein with the aid of real-time ultrasonography.

Study Overview

• Status: Unknown
• Conditions: Central Venous Catheterization
• Intervention / Treatment: Procedure: dilator depth

Detailed Description

This randomized controlled trial is to compare the distance between the skin puncture site and the outside of anterior wall of the internal jugular vein measured by real-time ultrasonography with the conventional method which is routinely used in common clinical practice.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jung-Man Lee, M.D.,PhD.; Phone Number: +82-2-870-2513; Email: jungman007@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients requiring central venous catheterization through the right internal jugular vein

Exclusion Criteria:

• suspicion for infection of the right neck site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: measured distance; In the modified Seldinger's maneuver, after guide-wire insertion into the right internal jugular vein, "we will measure the distance between the skin puncture site and the outside of anterior wall of the jugular vein. Next, we will insert the dilator on the guidewire by the measured length."	Procedure: dilator depth; For soft tissue dilation just after guidewire insertion in central venous catheterization through the right internal jugular vein, investigators will measure the distance between the skin puncture site and outside of anterior wall of the vein with real-time ultrasonography in the measured depth group. Next, practitioner will insert the dilator by the measured length and continue to insert the central venous catheter. For the conventional group as a control group, practitioner will perform the central venous catheterization with a manner used routinely by the practitioner.
No Intervention: conventional method; In the modified Seldinger's maneuver, after guide-wire insertion into the right internal jugular vein, "we will insert the dilator on the guidewire as commonly used method of the practitioners."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hematoma realted with the dilator	hematoma from the vascular wall puncture by the dilator	1 Day (on the study day for each patient)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
distance between skin puncture site and the outside of the anterior wall of the internal jugular vein	distance between skin puncture site and the outside of the anterior wall of the internal jugular vein which will be measured by real-time ultrasonography	1 Day (on the study day for each patient)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: SMG-SNU Boramae Medical Center
• Investigators: Principal Investigator: Jung-Man Lee, M.D.,PhD, SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 10-2019-3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No