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

Study Overview
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Brief Summary
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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.

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

Conditions
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Complication of Treatment, Catheterization

Intervention / Treatment
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* Procedure: Supra- vs Infraclavicular approach using ultrasonography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subclavian venous catheterization