NCT01196962

Brief Summary

There is no randomized controlled trial to compare the rates of complications associated with internal jugular and subclavian venous catheterization. The aim of this study is to compare mechanical, infectious, and thrombotic complications of internal jugular and subclavian venous catheterization. An improved understanding of CVC-related risks might help clinicians to choose one approach over the other in specific clinical settings.

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

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

September 1, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 27, 2012

Status Verified

August 1, 2011

Enrollment Period

3.1 years

First QC Date

September 1, 2010

Last Update Submit

November 22, 2012

Conditions

Time to InsertionRates of Complications

Keywords

central venous cathetercomplicationsinternal jugular veinrandomized trialsubclavian vein

Outcome Measures

Primary Outcomes (1)

  • Time to completely insertion

    1 hour

Secondary Outcomes (1)

  • rates of mechanical, infectious, and thrombotic complications

    14 days

Study Arms (1)

Internal jugular vein

EXPERIMENTAL
Device: Central venous catheter

Interventions

Central venous catheterDEVICE

Central venous catheter insertion to subclavian vein

Also known as: venous access
Internal jugular vein

Eligibility Criteria

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

You may qualify if:

  • admission to ICU
  • requiring central venous catheterization
  • without contraindications to attempt both jugular and internal jugular access

You may not qualify if:

  • the presence of a central venous catheter at admission
  • central venous catheterization within 2 weeks prior to admission
  • emergency catheterization for a life-threatening situation
  • major blood coagulation disorders
  • anatomic defect precluding catheterization at either site
  • skin lesions or recent surgery at either site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E-Da hospital

Kaohsiung City, 7, Taiwan

RECRUITING

MeSH Terms

Interventions

Central Venous CathetersVascular Access Devices

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Study Officials

  • Yu-Feng Wei, M.D.

    Chest department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Feng Wei, M.D.

CONTACT

+886-7-615-0011ed102746@edah.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2010

First Posted

September 9, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 27, 2012

Record last verified: 2011-08

Locations

TW(1)