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The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Surgical Patients: a Randomized-controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03595137
Recruitment Status : Unknown
Verified July 2018 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:
The purpose of this study is to evaluate the effect of simple needle guide device for ultrasound-guided internal jugular vein catheterization in surgical patients

Condition or disease Intervention/treatment Phase
Patients Undergoing Surgery Device: Sono with Device Device: Sono only Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. sono with simple needle guide device group
  2. sono only group
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Surgical Patients: a Randomized-controlled Trial
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: sono with simple needle guide device group (Group D)
sono with simple needle guide device Simple needle guide device was attached to the sono probe. Device was designed to assist the detection of the puncture site. After induction of anesthesia, sono-guided internal jugular vein cannulation was performed.
 Device: Sono with Device
In Group D, simple needle guide device was attached to the sono probe. Device was designed to assist the detection of the puncture site. After induction of anesthesia, sono-guided internal jugular vein cannulation was performed.
Placebo Comparator: sono only group (Group S)
sono only group After induction of anesthesia, sono-guided internal jugular vein cannulation was performed.
 Device: Sono only
In group S, sono-guided internal jugular vein cannulation was performed after induction of anesthesia


Outcome Measures
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Primary Outcome Measures :
  1. First access success rate [ Time Frame: up to 5 minutes after insertion of puncture needle ]
    First access success rate was defined as the number of sono-guided catheterization obtained within first attempt


Secondary Outcome Measures :
  1. insertion time [ Time Frame: 10 minutes after the beginning of the procedure ]
    defined as the time in seconds between the beginning of the procedure and guide-wire insertion

  2. complication rate [ Time Frame: 24 hours after surgery ]
    incidence of Pneumothorax, Haemothorax, Hydrothorax, carotid artery puncture, Hematoma, Malpositions, puncture of posterior wall of internal jugular vein

  3. ease of procedure [ Time Frame: 10 minutes after the beginning of the procedure ]
    In order to measure the degree of difficulty felt by the subjects during the procedure, a 100mm visual analogue scale was used to measure 10 difficulty levels (100mm; ease, 0mm ; difficult)

  4. the number of separate skin puncture [ Time Frame: 10 minutes after the beginning of the procedure ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. adult ( ≧19 years old)
  2. patients undergoing elective surgery

Exclusion Criteria:

  1. emergency surgery
  2. patients under cervical immobilization
  3. anatomical abnormality for Right internal jugular vein catheterization
  4. infection or hematoma at puncture site
  5. patients who did not need internal jugular vein catheterization
Contacts and Locations
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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): NCT03595137


Contacts
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Contact: Jin Ha Park Park, MD 82-2-2228-2420 realsummer@yuhs.ac

Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Jin Ha Park, MD    82-2-2228-2420    realsummer@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03595137    
Other Study ID Numbers: 1-2018-0027
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No