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出境医 / 临床实验 / Comparison of the Needle Tip Location by the Position of the Operator During Ultrasound Guided LIJV Catheterization.

Comparison of the Needle Tip Location by the Position of the Operator During Ultrasound Guided LIJV Catheterization.

Study Description
Brief Summary:
When the left internal jugular vein catheterization under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location.

Condition or disease Intervention/treatment Phase
Catheterization, Central Venous Other: Position change Other: Conventional position Not Applicable

Detailed Description:
When placing the central line catheter in the left internal jugular vein under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location. (Above the midline of patient's head versus above the left extended axillary line)
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of the Needle Tip Location According to the Position of the Operator During Short Axis Ultrasound Guided Central Venous Catheterization in the Left Internal Jugular Vein
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 30, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: Extended axillary midline
Operator stands at the bedside on extended midline of the patient's lt. axilla during lt. internal jugular vein catheterization
 Other: Position change
Different position during central line catheterization
Active Comparator: Extended head midline
Operator stands at the bedside on extended midline of the patient's head during lt. internal jugular vein catheterization.
 Other: Conventional position
Conventional position during central line catheterization
Outcome Measures
Primary Outcome Measures :
  1. Distance from needle tip to center of IJV [ Time Frame: intraoperative ]
    The distance that the needle tip is placed from the center of the jugular vein when the needle is fixed after the vascular puncture


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Central venous catheterization required on lt. IJV

Exclusion Criteria:

  • History of cervical spine surgery
  • Abnormal structure of cervical spine, carotid artery or jugular vein
  • Disease of carotid artery
  • Immobilization due to cervical spine fracture or other diseases.
Contacts and Locations

Contacts
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Contact: Tae Kyong Kim, MD, phD +82-2-870-2519 ktkktk@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 07061
Contact: Tae Kyong Kim, MD    82-10-3750-5193    ktkktk@gmail.com   
Contact: Dong Wook Won, MD    82-10-3194-9471    won2501@naver.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Tae Kyong Kim, MD, phD SMG-SNU Boramae hospital
Tracking Information
First Submitted Date  ICMJE May 2, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE May 2, 2019
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019) 		Distance from needle tip to center of IJV [ Time Frame: intraoperative ]
The distance that the needle tip is placed from the center of the jugular vein when the needle is fixed after the vascular puncture
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Needle Tip Location by the Position of the Operator During Ultrasound Guided LIJV Catheterization.
Official Title  ICMJE Comparison of the Needle Tip Location According to the Position of the Operator During Short Axis Ultrasound Guided Central Venous Catheterization in the Left Internal Jugular Vein
Brief Summary When the left internal jugular vein catheterization under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location.
Detailed Description When placing the central line catheter in the left internal jugular vein under short-axis ultrasound guided, an operator should be stand around the lying patient's head. The investigators are going to evaluate to effects of the operator's location. (Above the midline of patient's head versus above the left extended axillary line)
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Catheterization, Central Venous
Intervention  ICMJE
  • Other: Position change
    Different position during central line catheterization
  • Other: Conventional position
    Conventional position during central line catheterization
Study Arms  ICMJE
  • Experimental: Extended axillary midline
    Operator stands at the bedside on extended midline of the patient's lt. axilla during lt. internal jugular vein catheterization
    Intervention: Other: Position change
  • Active Comparator: Extended head midline
    Operator stands at the bedside on extended midline of the patient's head during lt. internal jugular vein catheterization.
    Intervention: Other: Conventional position
Publications *
  • Ishizuka M, Nagata H, Takagi K, Kubota K. Right internal jugular vein is recommended for central venous catheterization. J Invest Surg. 2010 Apr;23(2):110-4. doi: 10.3109/08941930903469342.
  • Lobato EB, Sulek CA, Moody RL, Morey TE. Cross-sectional area of the right and left internal jugular veins. J Cardiothorac Vasc Anesth. 1999 Apr;13(2):136-8.
  • Sulek CA, Blas ML, Lobato EB. A randomized study of left versus right internal jugular vein cannulation in adults. J Clin Anesth. 2000 Mar;12(2):142-5.
  • Lieberman JA, Williams KA, Rosenberg AL. Optimal head rotation for internal jugular vein cannulation when relying on external landmarks. Anesth Analg. 2004 Oct;99(4):982-8, table of contents.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 2, 2019) 		50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Central venous catheterization required on lt. IJV

Exclusion Criteria:

  • History of cervical spine surgery
  • Abnormal structure of cervical spine, carotid artery or jugular vein
  • Disease of carotid artery
  • Immobilization due to cervical spine fracture or other diseases.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936543
Other Study ID Numbers  ICMJE 20190311/10-2019-7/041
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tae Kyong Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tae Kyong Kim, MD, phD SMG-SNU Boramae hospital
PRS Account Seoul National University Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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