Completed

NCT Number: NCT03252197

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

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Emergency Medicine, Yonsei University College of Medicine, Yonsei University Severance Hospital

Seoul, 03722, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

UGIJVC with needle guide device

Device

Study subjects assigned to each group were trained in ultrasound guided internal jugular venous cannulation (UGIJVC) in separate spaces. On each session, subjects were educated about UGIJVC for 30 minutes, and the instructor who was in charge of session, consisted of experienced physicians who had 50 or more UGIJVC success experiences without a supervisor in clinical field. The instructors explained the anatomical structure and the principles of UGIJVC and then demonstrated the procedures directly to the subjects using phantom. After that, all subjects were instructed to perform hands on practice for 30 minutes. In case group, the instructor trained subjects using device. On the other hand in control group, UGIVJC was demonstrated as a conventional method of approaching the target vessel while confirming the needle tip on the ultrasound screen in real time without a device.

UGIJVC without needle guide device

Device

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

Other names: Conventional group

Primary outcomes

First attempt success

Time frame: Within 2 minutes or after start to insertion attempt

The first attempt success was defined as a successful attempt to perform a vein puncture in one attempt. The number of attempts was counted each time a subject inserted a guide needle into the phantom surface, followed by withdrawal, redirect, or reinsertion.

Secondary outcomes

Posterior wall puncture of the internal jugular procedure, comfort level with procedure

Time frame: Within 2 minutes or after start to insertion attempt

It was defined when the needle tip on the recorded ultrasound screen was confirmed to pass through the posterior wall measurement unit : Yes or no (categorical variable)
Carotid artery puncture

Time frame: Within 2 minutes or after start to insertion attempt

It was defined as the needle tip passing through the carotid lumen or the subject regurgitating artery water during cannulation attempt.

measurement unit : Yes or no (categorical variable)
Time to cannulation

Time frame: Within 2 minutes or after start to insertion attempt

It was defined as the time from time out for procedure start to end point measurement unit : second
Comfort level

Time frame: Within 2 minutes or after start to insertion attempt

It was defined subjective opinion about difficulty during procedure for each subject measurement unit : 100-mm visual analogue scale with 0 being the least of the difficulties and 10 being the highest.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Aug 17, 2017
Registry last updated: Aug 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.