NCT01026649

Brief Summary

To evaluate the effect of a 2-stage approach to the internal jugular vein when performing a central venous catheterization compared to the traditional one stage approach on the incidence of hematoma formation and success rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 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

November 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 20, 2016

Status Verified

April 1, 2016

Enrollment Period

2.5 years

First QC Date

November 19, 2009

Last Update Submit

April 19, 2016

Conditions

Hematoma

Keywords

hematoma formationsuccess rate

Outcome Measures

Primary Outcomes (1)

  • hematoma formation

    immediately after catheterization

Study Arms (2)

2 stage

EXPERIMENTAL

Approach the internal jugular vein in a 2 stage fashion during central venous catheterization

Procedure: Central venous catheterization

1 stage

ACTIVE COMPARATOR

Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization

Procedure: Central venous catheterization

Interventions

Central venous catheterizationPROCEDURE

Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization

1 stage

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who require a central venous catheter for their thoracic surgery

You may not qualify if:

  • Refuse to enroll
  • Infection at insertion site
  • Carotid artery disease
  • Anomaly of central vasculature
  • Hypertrophied thyroid
  • History of recent neck surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Hematoma

Interventions

Catheterization, Central Venous

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 19, 2009

First Posted

December 4, 2009

Study Start

November 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

April 20, 2016

Record last verified: 2016-04

Locations

KR(1)