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

Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677765
• Other study ID #: US_SVC: SC vs IC
• Status: Completed
• Phase: N/A
• Start date: November 27, 2018
• Est. completion date: May 19, 2020

Study information

• Verified date: June 2020
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: May 19, 2020
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheterization
• Complication of Treatment

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the first-pass success rate	The first-pass success was defined as successful catheterization on a single attempt in all stages of catheterization.	intraoperatively
Secondary	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
Secondary	Total time for venipuncture	Total time for venipuncture was defined as the amount of time which took for successful subclavian venous puncture.	intraoperatively