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

Not Applicable

Completed

• 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
• Interventions: Device: UGIJVC without needle guide device; Device: UGIJVC with needle guide device

• Registration Number: NCT03252197
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-03-11
• Primary Completion: 2017-06-24
• Study Completion: 2017-06-24
• Study First Submitted: 2017-07-28
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-14
• Last Update Submitted: 2017-08-14
• Study First Posted: 2017-08-17
• Last Update Posted: 2017-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional group	UGIJVC without needle guide device	participants who are tested performance for ultrasound guided cannulation using conventional method
New device group	UGIJVC with needle guide device	participants who are tested performance for ultrasound guided cannulation using device

Primary Outcome Measures

Name	Time	Method
First attempt success	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 Outcome Measures

Name	Time	Method
Posterior wall puncture of the internal jugular procedure, comfort level with procedure	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	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	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	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.

Trial Locations

Locations (1)

Department of Emergency Medicine, Yonsei University College of Medicine, Yonsei University Severance Hospital; 🇰🇷 Seoul, Korea, Republic of