NCT03936543

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 3, 2019

Status Verified

May 1, 2019

Enrollment Period

12 months

First QC Date

May 2, 2019

Last Update Submit

May 2, 2019

Conditions

Catheterization, Central Venous

Outcome Measures

Primary Outcomes (1)

  • Distance from needle tip to center of IJV

    The distance that the needle tip is placed from the center of the jugular vein when the needle is fixed after the vascular puncture

    intraoperative

Study Arms (2)

Extended axillary midline

EXPERIMENTAL

Operator stands at the bedside on extended midline of the patient's lt. axilla during lt. internal jugular vein catheterization

Other: Position change

Extended head midline

ACTIVE COMPARATOR

Operator stands at the bedside on extended midline of the patient's head during lt. internal jugular vein catheterization.

Other: Conventional position

Interventions

Position changeOTHER

Different position during central line catheterization

Extended axillary midline
Conventional positionOTHER

Conventional position during central line catheterization

Extended head midline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Central venous catheterization required on lt. IJV

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 07061, South Korea

RECRUITING

Related Publications (5)

  • 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.

    PMID: 20497014BACKGROUND

  • 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. doi: 10.1016/s1053-0770(99)90075-7.

    PMID: 10230944BACKGROUND

  • 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. doi: 10.1016/s0952-8180(00)00129-x.

    PMID: 10818329BACKGROUND

  • 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):982-988. doi: 10.1213/01.ANE.0000132908.77111.CA.

    PMID: 15385337BACKGROUND

  • Min SW, Kim H, Won D, Chang JE, Lee JM, Hwang JY, Kim TK. Comparison of the needle tip location with the operator's position during ultrasound-guided internal jugular vein catheterization: A randomized controlled study. Medicine (Baltimore). 2022 Oct 28;101(43):e31249. doi: 10.1097/MD.0000000000031249.

    PMID: 36316874DERIVED

Study Officials

  • Tae Kyong Kim, MD, phD

    SMG-SNU Boramae hospital

    STUDY DIRECTOR

Central Study Contacts

Tae Kyong Kim, MD, phD

CONTACT

+82-2-870-2519ktkktk@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 3, 2019

Study Start

May 2, 2019

Primary Completion

April 30, 2020

Study Completion

June 30, 2020

Last Updated

May 3, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)