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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT02878174

Collaborator

(none)

320

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Jugular Veins	Procedure: internal jugular vein catheterization	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Success rate of internal jugular vein cannulation [intraoperative]

Secondary Outcome Measures

Degree of rotation of ultrasound (US) probe [intraoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Seoul National University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chul-Woo Jung, Associate Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT02878174

Other Study ID Numbers:

IJV_rotation

First Posted:

Aug 25, 2016

Last Update Posted:

Jun 24, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Study Results

No Results Posted as of Jun 24, 2022