A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device

Yonsei University

Status: Completed

Conditions: Physicians Who Had Less Than 10 Ultrasound Guided Internal Jugular Vein Cannulation Participate in This Study; Doctors Attending a Central Line Insertion Training Courses for New Residents of a University Hospital From March 2017 to June 2017

Treatments: Device: UGIJVC with needle guide device; Device: UGIJVC without needle guide device

Study type: Interventional

Funder types: Other

Identifiers

NCT03252197

1-2016-0081

Details and patient eligibility

About

Two-dimensional ultrasound guided approach does not guarantee first attempt success on internal jugular vein cannulation. New attachable device recently was developed for accurate needle insertion when ultrasound is used. Our randomized parallel simulation study will examine whether this device will improve the first attempt success rate when ultrasound guided internal jugular vein catheterization of simulated internal jugular vein.

Full description

This was a prospective, randomized, parallel trial using phantom simulating internal jugular vein.

After informed consent all subjects will be randomized to insert needle for internal jugular vein cannulation of phantom using ultrasound approach with or without this device. Video camera will record all procedure process and ultrasound image in real time. Researchers blinded to the study aim measured outcome variables based on recorded images.

Enrollment: 88 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adults over 20
2. Resident in clinical hospital
3. Ultrasound-guided internal jugular vein insertion without supervisor experience less than 10

Exclusion criteria

1. If they have physical problem that is difficult to perform
2. If they do not want to participate in this study
3. If they can not understand the contents reading the informed consent
4. If they have more than 10 ultrasound guided internal jugular vein insertion without supervisor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

New device group

Experimental group

Description:

participants who are tested performance for ultrasound guided cannulation using device

Treatment:

Device: UGIJVC with needle guide device

Conventional group

Active Comparator group

Description:

participants who are tested performance for ultrasound guided cannulation using conventional method

Treatment:

Device: UGIJVC without needle guide device