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

NCT ID: NCT03252197

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-11
• Study Completion Date: 2017-06-24

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

New device group

participants who are tested performance for ultrasound guided cannulation using device

Group Type: EXPERIMENTAL

UGIJVC with needle guide device

Intervention Type: 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.

Conventional group

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

Group Type: ACTIVE_COMPARATOR

UGIJVC without needle guide device

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

UGIJVC without needle guide device

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

Intervention Type: DEVICE

Other Intervention Names

Conventional group

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

1-2016-0081

Identifier Type: -

Identifier Source: org_study_id