Influence of the Shoulder Position on the Catheter Tip Lo... | NCT01024881

Studies
Influence of the Shoulder Position on the Catheter Tip Location During Infraclavicular Subclavian Approach

NCT01024881

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Dec 3, 2009Estimated

Enrollment

344Actual

Phase

Not Applicable

Conditions

Catheter Tip Location

Interventions

neutral shoulder position
lowered shoulder position

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Dec 2, 2009

First Submission Date that Met QC Criteria

Dec 2, 2009

First Posted Date

Dec 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2009

Last Update Posted Date

Dec 3, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Infraclavicular approach of the subclavian veins is commonly used for central venous access. Aberrant locations of catheter tip are frequently quoted for this approach, but few studies have been performed to document the relationship between the shoulder position and catheter tip location. This prospective study was performed to assess the influence of the shoulder position on the safe and proper placement of infraclavicular subclavian catheters.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

344Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1	Active Comparator	neutral shoulder position during infraclavicular subclavian catheterization	Procedure: neutral shoulder position
group 2	Experimental	lowered shoulder position during infraclavicular subclavian catheterization	Procedure: lowered shoulder position

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neutral shoulder position	Procedure	neutral shoulder position during infraclavicular subclavian catheterization	group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
location of the catheter tip		at the end of surgery

Secondary Outcomes

Measure	Description	Time Frame
catheterization success rate		immediately after catheterization

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients requiring central venous catheterization due to major procedures such as neurosurgery or thoracic surgery.

Exclusion Criteria:

chest deformities,
coagulopathy,
diaphragmatic dysfunction,
pulmonary malformation,
history of prior clavicle fracture, or
infection over the puncture site.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul	Seoul	110-744	South Korea