Back to resultsUltrasound Guided Axillary Versus Jugular Central Venous Catheterization
Primary Purpose
Critical Illness
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Real-time ultrasound-guided central vein catheterization.
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring ultrasonography, catheterization, central line, mechanical ventilation, intensive care, axillary vein, jugular vein, randomization
Eligibility Criteria
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
Sites / Locations
- Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
- 2nd Department of Anesthesiology and Critical Care, Medical University of Lublin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Axillary catheterization
Jugular catheterization
Arm Description
Real-time ultrasound-guided axillary vein catheterization, in plain technique.
Real-time ultrasound-guided jugular vein catheterization, out of plain technique.
Outcomes
Primary Outcome Measures
Procedure success rate
to define catheterization success rate
Secondary Outcome Measures
Incidence of Catheter colonization
to assess the incidence of catheter colonization after removal
Incidence of catheter-related bloodstream infection
to assess the incidence of catheter-related bloodstream infection
Procedure complication rate
to assess the early mechanical complication rate
Full Information
NCT ID
NCT02624323
First Posted
November 29, 2015
Last Updated
August 3, 2020
Sponsor
Uniwersytecki Szpital Kliniczny w Opolu
1. Study Identification
Unique Protocol Identification Number
NCT02624323
Brief Title
Ultrasound Guided Axillary Versus Jugular Central Venous Catheterization
Official Title
Real-time Ultrasound-guided Axillary and Jugular Vein Catheterization: A Prospective Comparison in Mechanically Ventilated Critically Ill Patients. A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 3, 2020 (Actual)
Study Completion Date
August 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uniwersytecki Szpital Kliniczny w Opolu
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
ultrasonography, catheterization, central line, mechanical ventilation, intensive care, axillary vein, jugular vein, randomization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
614 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Axillary catheterization
Arm Type
Experimental
Arm Description
Real-time ultrasound-guided axillary vein catheterization, in plain technique.
Arm Title
Jugular catheterization
Arm Type
Experimental
Arm Description
Real-time ultrasound-guided jugular vein catheterization, out of plain technique.
Intervention Type
Procedure
Intervention Name(s)
Real-time ultrasound-guided central vein catheterization.
Primary Outcome Measure Information:
Title
Procedure success rate
Description
to define catheterization success rate
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Incidence of Catheter colonization
Description
to assess the incidence of catheter colonization after removal
Time Frame
1 month
Title
Incidence of catheter-related bloodstream infection
Description
to assess the incidence of catheter-related bloodstream infection
Time Frame
1 month
Title
Procedure complication rate
Description
to assess the early mechanical complication rate
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Czarnik, MD PhD
Organizational Affiliation
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
City
Opole
State/Province
Silesia
ZIP/Postal Code
45-401
Country
Poland
Facility Name
2nd Department of Anesthesiology and Critical Care, Medical University of Lublin
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Ultrasound Guided Axillary Versus Jugular Central Venous Catheterization
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