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A novel electromagnatic ultrasound-guided arterial line cannulation comparing with conventional ultrasound-guided technique

Status Approved

  • First Submitted Date

    2017/07/12

  • Registered Date

    2017/09/22

  • Last Updated Date

    2017/08/28

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002476
    Unique Protocol ID 4-2016-1041
    Public/Brief Title A novel electromagnatic ultrasound-guided arterial line cannulation comparing with conventional ultrasound-guided technique
    Scientific Title A novel electromagnatic ultrasound-guided arterial line cannulation comparing with conventional ultrasound-guided technique
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 4-2016-1041
    Approval Date 2017-01-19
    Institutional Review Board Name Yonsei University Health System, Severance Hospital, Institutional Review Board
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name hyo jin byon
    Title assist professor
    Telephone +82-2-2228-2429
    Affiliation Yonsei University
    Address Seoul Yonsei-ro 50-1 Seodaemun-gu
    Contact Person for Public Queries
    Name hyo jin byon
    Title assist professor
    Telephone +82-2-2228-2429
    Affiliation Yonsei University
    Address Seoul Yonsei-ro 50-1 Seodaemun-gu
    Contact Person for Updating Information
    Name hyo jin byon
    Title assist professor
    Telephone +82-2-2228-2429
    Affiliation Yonsei University
    Address Seoul Yonsei-ro 50-1 Seodaemun-gu
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2017-04-03 Actual
    Target Number of Participant 76
    Primary Completion Date 2017-12-29 , Anticipated
    Study Completion Date 2018-01-18 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2017-04-03 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Yonsei University Health System, Severance Hospital
    Organization Type Medical Institute
    Project ID 4-2016-1041
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Yonsei University Health System, Severance Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Intraarterial insufflation is an important procedure commonly practiced by patients who are undergoing intensive care or surgeries that require constant blood pressure monitoring. It is inserted into the radial artery, which can be accessed at various locations but is usually easy and less complicated. But the procedure is difficult in itself because only around 2mm in diameter vessels in the average adult. Therefore, ultrasound - guided insertion of the ductus arteriosus can be considered as a method to overcome these difficulties, to increase the initial success rate, to shorten the procedure time, and to reduce complications such as hematoma. However, this also affects the success rate of the procedure and the incidence of complications because the trainer of the operator and the resolution of the ultrasound do not track the path of the needle into the ultrasound screen when the needle is actually punctured.
    In recent years, ultrasound has been introduced in the clinical field to guide the insertion needle in real time during the procedure such as central venous catheterization or peripheral nerve block using the electromagnetic.
    This new device, called eZonoTM 4000 (eZono AG, Jena, Germany), shows the relative position and orientation of the ultrasonic probe and needle, the expected trajectory at the time of needle insertion and where the tip of the needle should be positioned on the cross section of the ultrasonic screen. It is reported that the complication rate can be reduced or decreased, and the novice can easily increase the success rate.
    We compared the success rate and complication rate of arterial line cannula with radial artery cannula using conventional ultrasonography.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Others
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Medical Device  
    Intervention Description
    If it is decided to participate in this study, it is divided into a control group and an eZono group through a computerized random assignment.
    All patients should be fully informed about the purpose and method of the study before the operation, and the research should be conducted in writing. Once the patient arrives at the exenteration room, confirm again that they have agreed to the study.
    After induction of general anesthesia, the patient is placed in the supine position, and allen test is performed to confirm that the peripheral arterial circulation of the hand is preserved, and then the radial artery that is punctured is sterilized with alcohol cotton.
    The size of the ductus arteriosum used in the procedure is 20g. The eZono 4000 (eZono AG, Jena, Germany) probe was used to "turn on" the electric field induction function and to insert the patent ductus in the eZono group. To 'turn off' and let it be punished.
    The ultrasound is placed parallel to the arterial axis and advanced by inserting a needle in an out-of-plane approach to the ultrasound. At this time, the time from the puncture of the skin to the point at which blood starts to come out from the needle by the arterial pressure is measured (T1). When the blood is aspirated, it is defined as the success of insertion of the ductal artery, and the time from the first needle through the needle to the time when the blood is aspirated is measured (T2). In addition, record the total number of punctures, success rate of blood aspiration, incidence of complications, and the number of 20g needle use. The procedure should be performed by a professional who has successfully passed the A-line at least 50 times using ultrasound
    Number of Arms 2
    Arm 1

    Arm Label

    eZono group

    Target Number of Participant

    38

    Arm Type

    Experimental

    Arm Description

    'Turn on' the electromagnetism induction function of the eZonoTM 4000 and insert the ductus.
    Arm 2

    Arm Label

    Groups not using e-zono

    Target Number of Participant

    38

    Arm Type

    Sham comparator

    Arm Description

    Turn off the electric field induction function of eZonoTM 4000 and insert the ductal tube.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    Not Applicable-Etc 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    Adult patients over 19 years of age who are required to have a A-line insertion
    Exclusion Criteria
    - Vascular malformations
    - hemodynamically unstable patient
    - Blood coagulation disorder
    - Patients with Peripheral Arterial Occlusive Disease
    - reoperation
    - emergency surgery
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    Percentage of success and vascular wall puncture
    Timepoint
    The time from when the skin is punctured to the point at which blood starts to form on the needle and starts to come out from the arterial pressure, the time from when the blood first comes out through the needle to the time when the blood is sucked
    Secondary Outcome(s) 1
    Outcome
    When anesthesia induces an unexpected side effect (anaphylaxis, difficult airway management, etc.) or other causes, such as severe hemodynamic changes or general condition of the patient is worsened.
    Timepoint
    During anesthesia induction, immediately after induction of anesthesia
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Not provided at time of Registration
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