NCT02878174

Brief Summary

Two approaches such as ultrasound (US)-guided and prelocation techniques are possible when the internal jugular vein cannulation is attempted with US. This study is a clinical trial that compares the success rates of both techniques and shows the non-inferiority of the prelocation technique. However, during prelocation technique, rotated screen of the US is used instead of original screen. The angle of rotation is determined by the degree of rotation of US probe where an accelerometer is attached.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Aug 2024

Typical duration for not_applicable

Status
not yet recruiting

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

Study Progress92%
Aug 2024Jul 2026

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
7.9 years until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

August 22, 2016

Last Update Submit

November 29, 2023

Conditions

Jugular Veins

Outcome Measures

Primary Outcomes (1)

  • Success rate of internal jugular vein cannulation

    intraoperative

Secondary Outcomes (1)

  • Degree of rotation of ultrasound (US) probe

    intraoperative

Study Arms (2)

conventional ultrasound (US)-guided group

ACTIVE COMPARATOR

internal jugular vein catheterization using conventional US-guided internal jugular vein (IJV) cannulation

Procedure: internal jugular vein catheterization

rotational Prelocation group

EXPERIMENTAL

internal jugular vein catheterization using landmark approach based on the rotation-adjusted US screen

Procedure: internal jugular vein catheterization

Interventions

internal jugular vein catheterizationPROCEDURE

internal jugular vein catheterization using ultrasound (US) or US-based prelocation techniques

conventional ultrasound (US)-guided grouprotational Prelocation group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for general anesthesia

You may not qualify if:

  • Refusal of consent
  • Patients with cervical spine injuries
  • Patients with atlanto-axial instability
  • Patients at risk of increased intracranial pressure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Chul-Woo Jung, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chul-Woo Jung Jung, MD

CONTACT

2-2-2072-0640jungcwoo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

August 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share