Ultrasound Guided Central Vein Catheterization and Compli... | NCT01510743

Studies
Ultrasound Guided Central Vein Catheterization and Complications

NCT01510743

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Aug 27, 2018Actual

Enrollment

1,484Actual

Phase

Not Applicable

Conditions

Brain Tumor

Interventions

Catheterization of subclavian vein
Catheterization of internal jugular vein

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

Aug 2018

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

Jan 30, 2012Actual

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Jan 9, 2012

First Submission Date that Met QC Criteria

Jan 13, 2012

First Posted Date

Jan 16, 2012Estimated

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

Aug 24, 2018

Last Update Posted Date

Aug 27, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hyo-Seok Na, Assistant professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

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

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.

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

1,484Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Catheterization of subclavian vein	Procedure	Catheterization of subclavian vein	Group SC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complication	any one of arterial puncture, hematoma, pneumothorax, hemothorax	during central vein catheterization and operation day

Secondary Outcomes

Measure	Description	Time Frame
Access time	from penetration of skin to aspiration of venous blood into the syringe	during central venous catheterization
Number of attempts	once/twice/three times

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing surgeries requiring central vein catheterizations for anesthetic management.

Exclusion Criteria:

Refuse
hematologic disorder
Anatomical abnormalities of central vein structure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin-Hee Kim, Professor	Seoul National University Bundang Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam	Gyounggi	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided