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Ultrasound-guided Catheterization of the Axillary Vein

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
ultrasound
Sponsored by
Uniwersytecki Szpital Kliniczny w Opolu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring ultrasonography, catheterization, central line, mechanical ventilation, intensive care, axillary vein

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • trauma and hematoma at the catheterization site
  • history of multiple central venous catheterizations (three or more)
  • chest wall deformities
  • major blood coagulation disorders
  • history of thoracic surgery
  • 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, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne w Opolu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

axillary vein catheterization

Arm Description

central venous catheter placement into the axillary vein under ultrasound guidance

Outcomes

Primary Outcome Measures

to define venipuncture, catheterization and entire procedure success rates
the venipuncture is defined as perforation of the axillary vein by the needle, the catheterization is defined as the placement of catheter in the final position, the entire procedure success rate is defined as the placement of catheter in the final position without early complications (assessed within 24 hours time frame)
to assess the erly complication rate of ultrasound-guided axillary vein catheterization
pneumothorax, puncture of the axillary artery, hemothorax, heart perforation, catheter malposition, significant arrhythmias, air embolism

Secondary Outcome Measures

to assess the correlation between entire procedure success rate and the side of catheterization
the left axillary vein or the right axillary vein
to assess the correlation between patients weight, height and depth, diameter of the axillary vein
the depth and diameter of the axillary vein is measured by ultrasonography

Full Information

First Posted
August 4, 2013
Last Updated
May 8, 2016
Sponsor
Uniwersytecki Szpital Kliniczny w Opolu
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1. Study Identification

Unique Protocol Identification Number
NCT01919528
Brief Title
Ultrasound-guided Catheterization of the Axillary Vein
Official Title
Real-time Ultrasound-guided Catheterization of the Axillary Vein in the Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (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
No

5. Study Description

Brief Summary
The central venous catheterization (central line placement) is the common procedure performed in the intensive care unit. This procedure is performed by percutaneous puncture of so called 'the central vein' and than advancement of the catheter over the guidewire (Seldinger technique). The tip of the catheter is left in the superior vena cava in the vicinity of the right atrium of the heart. Central veins are large veins in the human body passing the blood into the heart. Typical, clinical indications for the central line placement in the intensive care unit are hemodynamic monitoring, volume monitoring, administration of medications, long-term total parenteral nutrition, access for renal replacement therapy, difficult peripheral catheterization. There are two methods of the central venous catheterization in terms of visualization. First and older is the blind technique. The operator is locating the anatomical landmarks and then performing the entire procedure blindly by percutaneous puncture. This is called the landmark technique. Second and new is the ultrasound-guided technique. The operator is locating the vein using ultrasonography and then performing the entire procedure under ultrasonographic visualization. The real time ultrasound-guided central venous catheterization became the standard of care in recent years mainly because of safety issues (is regarded as safer than landmark technique) The catheterization of the axillary vein is not popular procedure in daily clinical practice. But it can be reasonable and safe alternative to others, typically performed central venous catheterizations like the internal jugular vein and the subclavian vein catheterizations. The main intention of this study is to assess usefulness and safety of the real time ultrasound guided axillary vein catheterization 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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
axillary vein catheterization
Arm Type
Experimental
Arm Description
central venous catheter placement into the axillary vein under ultrasound guidance
Intervention Type
Procedure
Intervention Name(s)
ultrasound
Intervention Description
catheterization of the axillary vein under ultrasound guidance
Primary Outcome Measure Information:
Title
to define venipuncture, catheterization and entire procedure success rates
Description
the venipuncture is defined as perforation of the axillary vein by the needle, the catheterization is defined as the placement of catheter in the final position, the entire procedure success rate is defined as the placement of catheter in the final position without early complications (assessed within 24 hours time frame)
Time Frame
24 hours
Title
to assess the erly complication rate of ultrasound-guided axillary vein catheterization
Description
pneumothorax, puncture of the axillary artery, hemothorax, heart perforation, catheter malposition, significant arrhythmias, air embolism
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
to assess the correlation between entire procedure success rate and the side of catheterization
Description
the left axillary vein or the right axillary vein
Time Frame
2 years
Title
to assess the correlation between patients weight, height and depth, diameter of the axillary vein
Description
the depth and diameter of the axillary vein is measured by ultrasonography
Time Frame
2 years

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 history of multiple central venous catheterizations (three or more) chest wall deformities major blood coagulation disorders history of thoracic surgery 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
Organizational Affiliation
Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne w Opolu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne w Opolu
City
Opole
ZIP/Postal Code
45-418
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25697988
Citation
Czarnik T, Gawda R, Nowotarski J. Real-time, ultrasound-guided infraclavicular axillary vein cannulation for renal replacement therapy in the critical care unit-A prospective intervention study. J Crit Care. 2015 Jun;30(3):624-8. doi: 10.1016/j.jcrc.2015.01.002. Epub 2015 Jan 8.
Results Reference
result
PubMed Identifier
26993368
Citation
Czarnik T, Gawda R, Nowotarski J. Real-time ultrasound-guided infraclavicular axillary vein cannulation: A prospective study in mechanically ventilated critically ill patients. J Crit Care. 2016 Jun;33:32-7. doi: 10.1016/j.jcrc.2016.02.021. Epub 2016 Mar 2.
Results Reference
result

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Ultrasound-guided Catheterization of the Axillary Vein

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