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

October 9, 2017 updated by: Hee-Pyoung Park, Seoul National University Hospital

A Difference in the Cross-section Area of Subclavian Vein Between Supine and Lateral Tilt Position: Its Clinical Impact on Subclavian Venous Catheterization - Stage II

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 first stage of this study, we compare the cross-sectional area of subclavian vein using ultrasonography in supine, ipsilateral, and contralateral tilt position.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

17

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ipsilateral tilt
Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.
Procedure: Ipsilateral tilt
The operation table will be tilted 20 degrees right laterally.
No Intervention: Supine
Measuring the cross-sectional area of right subclavian vein in supine position.
Active Comparator: Contralateral tilt
Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.
Procedure: Contralateral tilt
The operation table will be tilted 20 degrees left laterally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cross-sectional area of right subclavian vein
Time Frame: 1 minutes after position change
The cross-sectional area of right subclavian vein
1 minutes after position change

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2017

Primary Completion (Anticipated)

July 31, 2019

Study Completion (Anticipated)

July 31, 2019

Study Registration Dates

First Submitted

September 25, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-110-871-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Catheterization

Clinical Trials on Ipsilateral tilt

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe