NCT03296735

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

October 15, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

1.8 years

First QC Date

September 25, 2017

Last Update Submit

October 9, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • The cross-sectional area of right subclavian vein

    The cross-sectional area of right subclavian vein

    1 minutes after position change

Study Arms (3)

Ipsilateral tilt

EXPERIMENTAL

Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.

Procedure: Ipsilateral tilt

Supine

NO INTERVENTION

Measuring the cross-sectional area of right subclavian vein in supine position.

Contralateral tilt

ACTIVE COMPARATOR

Measuring the cross-sectional area of right subclavian vein in the 20 degree left tilting posture.

Procedure: Contralateral tilt

Interventions

The operation table will be tilted 20 degrees right laterally.

Ipsilateral tilt

The operation table will be tilted 20 degrees left laterally.

Contralateral tilt

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

Central Study Contacts

Hyung-Chul Lee, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2017

First Posted

September 28, 2017

Study Start

October 15, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

October 11, 2017

Record last verified: 2017-10