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

Not Applicable

Completed

• Conditions: Catheterization; Complication of Treatment
• Interventions: Procedure: Supra- vs Infraclavicular approach using ultrasonography

• Registration Number: NCT03677765
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-09
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-19
• Study Start: 2018-11-27
• Primary Completion: 2020-05-19
• Study Completion: 2020-05-19
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-29
• Last Update Posted: 2020-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 416

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infraclavicular group	Supra- vs Infraclavicular approach using ultrasonography	In the infraclavicular group, subclavian venous catheterization using ultrasonography is performed beneath the clavicle.
Supraclavicular group	Supra- vs Infraclavicular approach using ultrasonography	In the supraclavicular group, subclavian venous catheterization using ultrasonography is performed over the clavicle.

Primary Outcome Measures

Name	Time	Method
the overall incidence of complications	intraoperatively to 1 hour after the admission of ICU	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of