NCT01510743

Brief Summary

There has been no study comparing the complication rates between internal jugular vein catheterization and subclavian vein catheterization when they are performed using sonographic view. This prospective study would reveal the sort of complication and its rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,484

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 9, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

January 30, 2012

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

6.2 years

First QC Date

January 9, 2012

Last Update Submit

August 24, 2018

Conditions

Brain Tumor

Keywords

open heart surgerylung surgeryspine surgeryhepatobiliary surgery

Outcome Measures

Primary Outcomes (1)

  • complication

    any one of arterial puncture, hematoma, pneumothorax, hemothorax

    during central vein catheterization and operation day

Secondary Outcomes (3)

  • Access time

    during central venous catheterization

  • Number of attempts

    during central venous catheterization

  • catheter tip placement

    postoperative 1 day

Study Arms (2)

Group SC

ACTIVE COMPARATOR

US guided subclavian vein catheterization

Procedure: Catheterization of subclavian vein

Group IJ

ACTIVE COMPARATOR

US-guided internal jugular vein catheterization

Procedure: Catheterization of internal jugular vein

Interventions

Catheterization of subclavian veinPROCEDURE

Catheterization of subclavian vein

Group SC
Catheterization of internal jugular veinPROCEDURE

Catheterization of internal jugular vein

Group IJ

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing surgeries requiring central vein catheterizations for anesthetic management.

You may not qualify if:

  • Refuse
  • hematologic disorder
  • Anatomical abnormalities of central vein structure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Gyounggi, 463-707, South Korea

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jin-Hee Kim, Professor

    Seoul National University Bundang Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 16, 2012

Study Start

January 30, 2012

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations

KR(1)