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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Device: UGIJVC with needle guide device
* Device: UGIJVC without needle guide device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New device group<br>participants who are tested performance for ultrasound guided cannulation using device | Device: UGIJVC with needle guide device<br>* 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.<br>|
| Active Comparator: Conventional group<br>participants who are tested performance for ultrasound guided cannulation using conventional method | Device: UGIJVC without needle guide device<br>* participants who are tested performance for ultrasound guided cannulation using conventional method.<br>* Other names: Conventional group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First attempt success | 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. | Within 2 minutes or after start to insertion attempt | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Posterior wall puncture of the internal jugular procedure, comfort level with procedure | 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) | Within 2 minutes or after start to insertion attempt | 
| Carotid artery puncture | 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) | Within 2 minutes or after start to insertion attempt | 
| Time to cannulation | It was defined as the time from time out for procedure start to end point measurement unit : second | Within 2 minutes or after start to insertion attempt | 
| Comfort level | 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. | Within 2 minutes or after start to insertion attempt | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound guided central venous cannulation, new device, first attempt success