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NCT02624323 Clinical Trial

Ultrasound Guided Axillary Versus Jugular Central Venous Catheterization

Critical Illness Clinical Trial

Official title:
Real-time Ultrasound-guided Axillary and Jugular Vein Catheterization: A Prospective Comparison in Mechanically Ventilated Critically Ill Patients. A Randomized Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02624323
Other study ID # AxillaryJugularUSG-RCT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date August 3, 2020

Study information
Verified date August 2020
Source Uniwersytecki Szpital Kliniczny w Opolu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main intention of this study is to compare two ultrasound-guided central venous catheterization procedures namely: real-time, ultrasound-guided, in plane axillary vein catheterization and real-time, ultrasound-guided, out of plane jugular vein catheterization in terms of venipuncture, catheterization success, early mechanical complication and catheter-related infection rate in mechanically ventilated patients admitted to the intensive care unit.

Recruitment information / eligibility
Status Completed
Enrollment 614
Est. completion date August 3, 2020
Est. primary completion date August 3, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- mechanically ventilated intensive care patients with clinical indications for central venous line placement

Exclusion Criteria:

- trauma and hematoma at the catheterization site

- major blood coagulation disorders coincided with active bleeding

- anatomical abnormalities at the catheterization site

- infection at the catheterization site

- age less than 18 years

- lack of patients or closest relatives consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Real-time ultrasound-guided central vein catheterization.

Locations
Country Name City State
Poland 2nd Department of Anesthesiology and Critical Care, Medical University of Lublin Lublin
Poland Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu Opole Silesia

Sponsors (1)
Lead Sponsor Collaborator
Uniwersytecki Szpital Kliniczny w Opolu

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Procedure success rate to define catheterization success rate 24 hours
Secondary Incidence of Catheter colonization to assess the incidence of catheter colonization after removal 1 month
Secondary Incidence of catheter-related bloodstream infection to assess the incidence of catheter-related bloodstream infection 1 month
Secondary Procedure complication rate to assess the early mechanical complication rate 24 hours
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