The Site of Puncture in Prelocation Technique of the Internal Jugular Venous Catheterization

The Site of Puncture in Ultrasound-guided Prelocation Technique of the Internal Jugular Venous Catheterization: Non-inferiority Randomized Clinical Trial

Two approaches such as ultrasound (US)-guided and prelocation techniques are possible when the internal jugular vein cannulation is attempted with US. This study is a clinical trial that compares the success rates of both techniques and shows the non-inferiority of the prelocation technique. However, during prelocation technique, rotated screen of the US is used instead of original screen. The angle of rotation is determined by the degree of rotation of US probe where an accelerometer is attached.

Study Overview

• Status: Not yet recruiting
• Conditions: Jugular Veins
• Intervention / Treatment: Procedure: internal jugular vein catheterization

Detailed Description

The investigator's own developed screen-rotating program is used. An accelerometer is attached on the front surface of the ultrasound (US) probe. The angle of rotation of the probe is delivered to the laptop and becomes the information to adjust the rotating angle of screen. Immediately after induction of general anesthesia, the patient's head is turned slightly, and the table is tilted at 10 degrees. In the US group, the investigators obtain a sonographic view and try a cannulation of the internal jugular vein (IJV). In the prelocation group, a skin marker is made on the anticipated skin puncture site where a perpendicular line that passes over the center of the IJV meets the skin on the rotated US screen. It is recorded "success" when the internal jugular vein is successfully punctured without complications. It is recorded "failure" if the internal jugular vein is not punctured during repeated needle passes. The number of tries and tile to success are recorded. The success and complication rates between two groups are compared.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chul-Woo Jung Jung, MD; Phone Number: 2-2-2072-0640; Email: jungcwoo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients scheduled for general anesthesia

Exclusion Criteria:

• Refusal of consent
• Patients with cervical spine injuries
• Patients with atlanto-axial instability
• Patients at risk of increased intracranial pressure

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional ultrasound (US)-guided group; internal jugular vein catheterization using conventional US-guided internal jugular vein (IJV) cannulation	Procedure: internal jugular vein catheterization; internal jugular vein catheterization using ultrasound (US) or US-based prelocation techniques
Experimental: rotational Prelocation group; internal jugular vein catheterization using landmark approach based on the rotation-adjusted US screen	Procedure: internal jugular vein catheterization; internal jugular vein catheterization using ultrasound (US) or US-based prelocation techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success rate of internal jugular vein cannulation	intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Degree of rotation of ultrasound (US) probe	intraoperative

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Chul-Woo Jung, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 22, 2016
• First Posted (Estimated): August 25, 2016

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IJV_rotation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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