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

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 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.

Study Overview

• Status: Unknown
• Conditions: Catheterization; Posture
• Intervention / Treatment: Procedure: Ipsilateral tilt

• Study Type: Interventional
• Enrollment (Anticipated): 220
• Phase: Not Applicable

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ipsilateral tilt; The operation table will be tilted 20 degrees right laterally before subclavian venous catheterization.	Procedure: Ipsilateral tilt; The operation table will be tilted 20 degrees right laterally.
NO_INTERVENTION: Supine; Catheterization of right subclavian vein in supine position.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	during subclavian venous catheterization
Time to insert dilator	Time to insert dilator	during subclavian venous catheterization
The number of trial to insert catheter	The number of trial to insert catheter	during subclavian venous catheterization
Time to insert catheter	Time to insert catheter	during subclavian venous catheterization
Success of catheter insertion	Final success of catheter insertion within 6 trials	during subclavian venous catheterization
Other complications with central venous catheterization	complications with central venous catheterization such as arterial puncture, perivascular hematoma, pneumothorax, and malpositioning	From subclavian venous catheterization to 24 hours after operation finished

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.
• Jung DE, Lee HC, Yoon HK, Park HP. The effects of ipsilateral tilt position on right subclavian venous catheterization: study protocol for a prospective randomized trial. Trials. 2018 May 24;19(1):292. doi: 10.1186/s13063-018-2666-8.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 20, 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: October 2, 2017
• First Posted (ACTUAL): October 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 1707-110-871-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No