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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03677765
Enrollment
416
Registered
2018-09-19
Start date
2018-11-27
Completion date
2020-05-19
Last updated
2020-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheterization, Complication of Treatment

Keywords

subclavian venous catheterization

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.

Interventions

PROCEDURESupra- 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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the overall incidence of complicationsintraoperatively to 1 hour after the admission of ICUThe 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

MeasureTime frameDescription
the first-pass success rateintraoperativelyThe first-pass success was defined as successful catheterization on a single attempt in all stages of catheterization.
the number of needling for venipunctureintraoperativelyThe number of needling for venipuncture was defined as the amount of needling for successful subclavian venous puncture.
Total time for venipunctureintraoperativelyTotal time for venipuncture was defined as the amount of time which took for successful subclavian venous puncture.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026