NCT03303274

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.

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
220

participants targeted

Target at P75+ 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
11 days until next milestone

First Posted

Study publicly available on registry

October 6, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

October 20, 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 6, 2017

Status Verified

October 1, 2017

Enrollment Period

1.8 years

First QC Date

September 25, 2017

Last Update Submit

October 2, 2017

Conditions

CatheterizationPosture

Outcome Measures

Primary Outcomes (1)

  • The number of needle passage

    The number of needle passage for puncture of subclavian vein

    during subclavian venous catheterization

Secondary Outcomes (7)

  • Time to puncture subclavian vein

    during subclavian venous catheterization

  • Time to insert guidewire

    during subclavian venous catheterization

  • Time to insert dilator

    during subclavian venous catheterization

  • The number of trial to insert catheter

    during subclavian venous catheterization

  • Time to insert catheter

    during subclavian venous catheterization

  • +2 more secondary outcomes

Study Arms (2)

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

Ipsilateral tiltPROCEDURE

The operation table will be tilted 20 degrees right laterally.

Ipsilateral 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.

    PMID: 32891115DERIVED

  • 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.

    PMID: 29793550DERIVED

Central Study Contacts

Hyung-Chul Lee, MD

CONTACT

+82-10-2456-6336lucid80@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 25, 2017

First Posted

October 6, 2017

Study Start

October 20, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

October 6, 2017

Record last verified: 2017-10