A Difference in Subclavian Vein Catheterization Between S... | NCT03303274

Studies
A Difference in Subclavian Vein Catheterization Between Supine and Lateral Tilt Position - Stage II

NCT03303274

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Oct 6, 2017Actual

Enrollment

220Estimated

Phase

Not Applicable

Conditions

Catheterization
Posture

Interventions

Ipsilateral tilt

Countries

Not provided

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

Oct 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2017Estimated

Primary Completion Date

Jul 31, 2019Estimated

Completion Date

Jul 31, 2019Estimated

First Submitted Date

Sep 25, 2017

First Submission Date that Met QC Criteria

Oct 2, 2017

First Posted Date

Oct 6, 2017Actual

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

Oct 2, 2017

Last Update Posted Date

Oct 6, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hee-Pyoung Park, Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Central venous catheterization is widely used for various purposes during surgery. For central venous catheterization, subclavian vein is selected because of the relatively low risk of infection, long-term patency and low patient discomfort. The cross - sectional area of the subclavian vein is an important factor to increase success rate. Several studies have reported that the Trendelenburg position increases the cross-sectional area of the subclavian vein, and the lateral tilt position can change the cross-sectional area of the subclavian vein. However, the impact of lateral tilt position to the cross-sectional area of the subclavian vein is not clear. The ipsilateral position can increase the cross-sectional area of the subclavian vein, and the contralateral position can decrease the cross-sectional area by gravity.

In the second stage of this study, the investigators would like to compare the success rate, the number of needle passage, time to complete subclavian vein catheterization in supine and ipsilateral tile position.

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

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ipsilateral tilt	Experimental	The operation table will be tilted 20 degrees right laterally before subclavian venous catheterization.	Procedure: Ipsilateral tilt
Supine	No Intervention	Catheterization of right subclavian vein in supine position.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ipsilateral tilt	Procedure	The operation table will be tilted 20 degrees right laterally.	Ipsilateral tilt

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of needle passage	The number of needle passage for puncture of subclavian vein	during subclavian venous catheterization

Secondary Outcomes

Measure	Description	Time Frame
Time to puncture subclavian vein	Time to puncture subclavian vein	during subclavian venous catheterization
Time to insert guidewire	Time to insert guidewire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- the patients who receive elective neurosurgical surgery and require central venous catheter

Exclusion Criteria:

the patients who have puncture site infection
the patients who have chemoport, pacemaker in right subclavian vein
the patients who had received right mastectomy or right pneumonectomy
other contraindications for subclavian venous catheterization (eg. mass, hematoma, vegetation, and anticoagulation)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hyung-Chul Lee, MD	Contact	+82-10-2456-6336		lucid80@gmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32891115	Derived	Yoon HK, Lee HC, Kang P, Lee JM, Park HP, Cho YJ. Effects of ipsilateral tilt position on the cross-sectional area of the subclavian vein and the clinical performance of subclavian vein catheterization: a prospective randomized trial. BMC Anesthesiol. 2020 Sep 5;20(1):226. doi: 10.1186/s12871-020-01144-1.
29793550	Derived