Comparisons of Complications Related to Two Approaches of Ultrasonography-guided Subclavian Venous Catheterization

A Prospective Non-inferiority Trial on Complications Related to Ultrasonography-guided Subclavian Venous Catheterization: Supraclavicular Versus Infraclavicular Approach

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.

Study Overview

• Status: Completed
• Conditions: Catheterization; Complication of Treatment
• Intervention / Treatment: Procedure: Supra- vs Infraclavicular approach using ultrasonography

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Infraclavicular group; In the infraclavicular group, subclavian venous catheterization using ultrasonography is performed beneath the clavicle.	Procedure: Supra- vs Infraclavicular approach using ultrasonography; 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.
Active Comparator: Supraclavicular group; In the supraclavicular group, subclavian venous catheterization using ultrasonography is performed over the clavicle.	Procedure: Supra- vs Infraclavicular approach using ultrasonography; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the first-pass success rate	The first-pass success was defined as successful catheterization on a single attempt in all stages of catheterization.	intraoperatively
the number of needling for venipuncture	The number of needling for venipuncture was defined as the amount of needling for successful subclavian venous puncture.	intraoperatively
Total time for venipuncture	Total time for venipuncture was defined as the amount of time which took for successful subclavian venous puncture.	intraoperatively

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2018
• Primary Completion (Actual): May 19, 2020
• Study Completion (Actual): May 19, 2020

Study Registration Dates

• First Submitted: September 9, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: subclavian venous catheterization
• Other Study ID Numbers: US_SVC: SC vs IC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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