NCT01003366

Brief Summary

To test the hypothesis that approaching the internal jugular vein with the needle bevel down would produce less injury to the vessel wall compared to the bevel up approach during central venous catheterization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
338

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2009

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 22, 2011

Status Verified

March 1, 2011

Enrollment Period

1.8 years

First QC Date

October 27, 2009

Last Update Submit

March 18, 2011

Conditions

Central Venous Catheterization

Keywords

safety during central venous catheterization

Outcome Measures

Primary Outcomes (1)

  • posterior wall puncture of internal jugular vein

    immediately after catheterization

Study Arms (2)

bevel down

EXPERIMENTAL

approaching the IJV with the needle bevel facing down

Device: bevel direction during central venous catheterization

bevel up

ACTIVE COMPARATOR

approaching the IJV with the needle bevel facing up

Device: bevel direction during central venous catheterization

Interventions

bevel direction during central venous catheterizationDEVICE

approaching the IJV with the needle bevel facing down

bevel down

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing surgery that requires the placement of a central venous catheter at the internal jugular vein

You may not qualify if:

  • anatomical anomaly in the neck region
  • recent history of central venous catheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

March 22, 2011

Record last verified: 2011-03

Locations

KR(1)