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An Infraclavicular Landmark-based Approach to the Axillary Vein

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Catheterization of the axillary vein.
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 critical care, catheterization, axillary vein

Eligibility Criteria

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

Inclusion Criteria:

  • patients admitted to the intensive care unit with indications for central venous catheterization

Exclusion Criteria:

  • chest wall deformities at the cannulations side
  • major hemostasis disorders
  • infections at the catheterization site
  • age less than 18 years
  • lack of patients consent

Sites / Locations

  • Department of Anesthesiology and Intensive Care, Publiczny Samodzielny Zaklad Opieki Zdrowotnej Wojewodzkie Centrum Medyczne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

axillary vein catheterization

Arm Description

Catheterization of the axillary vein based on anatomical landmark.

Outcomes

Primary Outcome Measures

Rate of successful catheterizations.
Procedure success rate depending on physician experience.

Secondary Outcome Measures

Rate of early complications.

Full Information

First Posted
March 4, 2014
Last Updated
June 13, 2016
Sponsor
Uniwersytecki Szpital Kliniczny w Opolu
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1. Study Identification

Unique Protocol Identification Number
NCT02083458
Brief Title
An Infraclavicular Landmark-based Approach to the Axillary Vein
Official Title
A New Infraclavicular Landmark-based Approach to the Axillary Vein as an Alternative Method of Central Venous Cannulation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
February 2014 (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 line placement is the widespread procedure performed in the intensive care and emergency medicine. Indications for this procedure are chiefly lack of peripheral catheters, administration some medications, renal replacement therapy, parenteral nutrition and hemodynamic monitoring. The procedure is performed by percutaneous puncture of large vein of the neck and the thorax - internal jugular vein or subclavian vein, then insertion of guidewire through the needle and placement of the catheter over the guidewire. The tip of the catheter is situated in the superior vena cava. There are two techniques of catheterizations: landmark-based and ultrasound-guided. The most frequently cannulated veins in landmark-based approach are internal jugular and subclavian vein. The cannulation of the axillary vein is not common procedure in the intensive care unit, mainly due its complicated original technique. The primary intention of this study was to describe and assess usefulness and safety of the new landmark-based technique of catheterization of the axillary vein in 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
critical care, catheterization, 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
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
axillary vein catheterization
Arm Type
Experimental
Arm Description
Catheterization of the axillary vein based on anatomical landmark.
Intervention Type
Procedure
Intervention Name(s)
Catheterization of the axillary vein.
Primary Outcome Measure Information:
Title
Rate of successful catheterizations.
Time Frame
24 hours
Title
Procedure success rate depending on physician experience.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Rate of early complications.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients admitted to the intensive care unit with indications for central venous catheterization Exclusion Criteria: chest wall deformities at the cannulations side major hemostasis disorders infections at the catheterization site age less than 18 years lack of patients consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryszard Gawda, 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
City
Opole
ZIP/Postal Code
45-418
Country
Poland

12. IPD Sharing Statement

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An Infraclavicular Landmark-based Approach to the Axillary Vein

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