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.

Study Overview

• Status: 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
• Intervention / Treatment: Device: UGIJVC with needle guide device; Device: UGIJVC without needle guide device

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Emergency Medicine, Yonsei University College of Medicine, Yonsei University Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2017
• Primary Completion (Actual): June 24, 2017
• Study Completion (Actual): June 24, 2017

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (Actual): August 17, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2017
• Last Update Submitted That Met QC Criteria: August 14, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: first attempt success; Ultrasound guided central venous cannulation; new device
• Other Study ID Numbers: 1-2016-0081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No