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Completed

NCT Number: NCT03677765

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

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.

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Key information

Conditions

Complication of Treatment Catheterization

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supra- vs Infraclavicular approach using ultrasonography

Procedure

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.

Primary outcomes

  1. the overall incidence of complications

    Time frame: 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 outcomes

  1. the first-pass success rate

    Time frame: intraoperatively

    The first-pass success was defined as successful catheterization on a single attempt in all stages of catheterization.

  2. the number of needling for venipuncture

    Time frame: intraoperatively

    The number of needling for venipuncture was defined as the amount of needling for successful subclavian venous puncture.

  3. Total time for venipuncture

    Time frame: intraoperatively

    Total time for venipuncture was defined as the amount of time which took for successful subclavian venous puncture.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2018
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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