NCT03677765

Brief Summary

For performing subclavian venous catheterization, two approaches (supraclavicular and infraclavicular) have been used successfully in various clinical practice. However, there remains controversy concerning which approach is safer and causes less complications during ultrasonography-guided subclavian venous catheterization. In this context, the investigators sought to compare supraclavicular approach with infraclavicular approach in terms of post-procedural complications during ultrasonography-guided subclavian venous catheterization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

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 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 27, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

1.5 years

First QC Date

September 9, 2018

Last Update Submit

June 29, 2020

Conditions

Complication of TreatmentCatheterization

Keywords

subclavian venous catheterization

Outcome Measures

Primary Outcomes (1)

  • the overall incidence of complications

    The overall incidence of complications will be expressed as the sum of incidences of complications which occurred during subclavian venous catheterization including arterial puncture, hematoma formation, pneumothorax, hemothorax, and malposition of catheter. Arterial puncture, hematoma formation, and malposition of catheter will be evaluated with ultrasonography, and pneumothorax and hemothorax will be evaluated by chest radiography.

    intraoperatively to 1 hour after the admission of ICU

Secondary Outcomes (3)

  • the first-pass success rate

    intraoperatively

  • the number of needling for venipuncture

    intraoperatively

  • Total time for venipuncture

    intraoperatively

Study Arms (2)

Infraclavicular group

ACTIVE COMPARATOR

In the infraclavicular group, subclavian venous catheterization using ultrasonography is performed beneath the clavicle.

Procedure: Supra- vs Infraclavicular approach using ultrasonography

Supraclavicular group

ACTIVE COMPARATOR

In the supraclavicular group, subclavian venous catheterization using ultrasonography is performed over the clavicle.

Procedure: Supra- vs Infraclavicular approach using ultrasonography

Interventions

Supra- vs Infraclavicular approach using ultrasonographyPROCEDURE

In the supraclavicular group, subclavian venous catheterization using ultrasonography is performed beneath the clavicle. Meanwhile, in the infraclavicular group, subclavian venous catheterization using ultrasonography is performed over the clavicle.

Infraclavicular groupSupraclavicular group

Eligibility Criteria

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

You may qualify if:

  • patients who require subclavian venous catheterization
  • adult patients aged 20-79

You may not qualify if:

  • patient's refusal
  • patients with contraindication of subclavian venous catheterization (skin infection at puncture site, tumor or thrombus in the course of subclavian vein, vegetation at tricuspid valve, patients on anticoagulation)
  • patients with chemoport or pacemaker in subclavian vein
  • patients with right-sided breast cancer operation or with right-sided pneumonectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Kim YJ, Ma S, Yoon HK, Lee HC, Park HP, Oh H. Supraclavicular versus infraclavicular approach for ultrasound-guided right subclavian venous catheterisation: a randomised controlled non-inferiority trial. Anaesthesia. 2022 Jan;77(1):59-65. doi: 10.1111/anae.15525. Epub 2021 Jul 6.

    PMID: 34231204DERIVED

Study Officials

  • Hee-pyoung Park, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 9, 2018

First Posted

September 19, 2018

Study Start

November 27, 2018

Primary Completion

May 19, 2020

Study Completion

May 19, 2020

Last Updated

July 1, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)