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

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ClinicalTrials.gov Identifier: NCT03252197
Recruitment Status : Completed
First Posted : August 17, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Device: UGIJVC with needle guide device Device: UGIJVC without needle guide device Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blinded to study arm, Outcome assessor measured outcome variables based on recorded images.
Primary Purpose: Treatment
Official Title: A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device
Actual Study Start Date : March 11, 2017
Actual Primary Completion Date : June 24, 2017
Actual Study Completion Date : June 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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 Name: Conventional group




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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)


  3. 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

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03252197


Locations
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Korea, Republic of
Department of Emergency Medicine, Yonsei University College of Medicine, Yonsei University Severance Hospital
Seoul, Korea, Republic of, 03722
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03252197     History of Changes
Other Study ID Numbers: 1-2016-0081
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Ultrasound guided central venous cannulation
new device
first attempt success