NCT02624323CompletedNot Applicable
Real-time Ultrasound-guided Axillary and Jugular Vein Catheterization: A Prospective Comparison in Mechanically Ventilated Critically Ill Patients. A Randomized Study
Uniwersytecki Szpital Kliniczny w Opolu4 sites in 1 country614 target enrollmentStarted: August 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 614
- Locations
- 4
- Primary Endpoint
- Procedure success rate
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Procedure success rate
Time Frame: 24 hours
to define catheterization success rate
Secondary Outcomes
- Incidence of catheter-related bloodstream infection(1 month)
- Incidence of Catheter colonization(1 month)
- Procedure complication rate(24 hours)
Investigators
Tomasz Czarnik, MD PhD
Principal Investigator
Uniwersytecki Szpital Kliniczny w Opolu
Study Sites (4)
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