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Ultrasound Guided Central Vein Catheterization and Complications

Primary Purpose

Brain Tumor

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Catheterization of subclavian vein
Catheterization of internal jugular vein
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Tumor focused on measuring open heart surgery, lung surgery, spine surgery, hepatobiliary surgery

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing surgeries requiring central vein catheterizations for anesthetic management.

Exclusion Criteria:

  • Refuse
  • hematologic disorder
  • Anatomical abnormalities of central vein structure

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group SC

Group IJ

Arm Description

US guided subclavian vein catheterization

US-guided internal jugular vein catheterization

Outcomes

Primary Outcome Measures

complication
any one of arterial puncture, hematoma, pneumothorax, hemothorax

Secondary Outcome Measures

Access time
from penetration of skin to aspiration of venous blood into the syringe
Number of attempts
once/twice/three times
catheter tip placement
After reviewing the postoperative chest X ray film, we will check the position of the central venous catheter tip. The possible pisition of catheter tip is as follows: (1) Superior vena cava and Rirht Atrium junction (2)Right internal jugular vein (3)Left Internal jugular vein (4)Right Axillary vein (5)Lt. Axillary vein

Full Information

First Posted
January 9, 2012
Last Updated
August 24, 2018
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01510743
Brief Title
Ultrasound Guided Central Vein Catheterization and Complications
Official Title
Incidence of Complication Depending on the Cannulation Site in US Guided Central Vein Catheterization
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 30, 2012 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
open heart surgery, lung surgery, spine surgery, hepatobiliary surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1484 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group SC
Arm Type
Active Comparator
Arm Description
US guided subclavian vein catheterization
Arm Title
Group IJ
Arm Type
Active Comparator
Arm Description
US-guided internal jugular vein catheterization
Intervention Type
Procedure
Intervention Name(s)
Catheterization of subclavian vein
Intervention Description
Catheterization of subclavian vein
Intervention Type
Procedure
Intervention Name(s)
Catheterization of internal jugular vein
Intervention Description
Catheterization of internal jugular vein
Primary Outcome Measure Information:
Title
complication
Description
any one of arterial puncture, hematoma, pneumothorax, hemothorax
Time Frame
during central vein catheterization and operation day
Secondary Outcome Measure Information:
Title
Access time
Description
from penetration of skin to aspiration of venous blood into the syringe
Time Frame
during central venous catheterization
Title
Number of attempts
Description
once/twice/three times
Time Frame
during central venous catheterization
Title
catheter tip placement
Description
After reviewing the postoperative chest X ray film, we will check the position of the central venous catheter tip. The possible pisition of catheter tip is as follows: (1) Superior vena cava and Rirht Atrium junction (2)Right internal jugular vein (3)Left Internal jugular vein (4)Right Axillary vein (5)Lt. Axillary vein
Time Frame
postoperative 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Hee Kim, Professor
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyounggi
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Ultrasound Guided Central Vein Catheterization and Complications

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