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Ultrasound-guided Axillary Artery vs Femoral Artery Cannulation. (AxFemArt)

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.
Real-time ultrasound-guided out-of-plane femoral artery cannulation.
Sponsored by
Uniwersytecki Szpital Kliniczny w Opolu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring axillay artery, cannulation, femoral artery

Eligibility Criteria

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

Inclusion Criteria:

mechanically ventilated critically ill patients with indications for artery cannulation:

  • in whom radial artery cannulation is unable to perform or
  • in order to conduct hemodynamic monitoring using transpulmonary thermodilution

Exclusion Criteria:

  • age less than 18 years
  • trauma and hematoma at the catheterization site
  • clinically significant coagulation disorders
  • infection at the catheterization site
  • lack of patients or closest relatives contents
  • precedent surgery operation into the femoral and axillary arteries
  • clinically significant ischemia of the limb at the cannulation side

Sites / Locations

  • Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Axillary artery.

Femoral artery.

Arm Description

Cannulation of the axillary artery.

Cannulation of the femoral artery.

Outcomes

Primary Outcome Measures

Cannulation success rate
The goal of the assessment of the cannulation success rate is essential for the estimation of the usefulness of both artery approaches in clinical practice.

Secondary Outcome Measures

Procedure complication rate.
The goal of the assessment of the early mechanical complication rate is crucial for the estimation of the safety of both procedures in clinical practice.
Number of puncture attempts.
The goal of the assessment is the evaluation which approach is easier to perform.

Full Information

First Posted
June 7, 2016
Last Updated
December 19, 2021
Sponsor
Uniwersytecki Szpital Kliniczny w Opolu
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1. Study Identification

Unique Protocol Identification Number
NCT02801825
Brief Title
Ultrasound-guided Axillary Artery vs Femoral Artery Cannulation.
Acronym
AxFemArt
Official Title
A Randomized Study of Ultrasound-guided Axillary and Femoral Artery Cannulation in Mechanically Ventilated Critically Ill Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uniwersytecki Szpital Kliniczny w Opolu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of the study is to compare two ultrasound-guided arterial cannulation procedures: in-plane infraclavicular axillary artery cannulation and out-of-plane femoral artery cannulation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
axillay artery, cannulation, femoral artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Axillary artery.
Arm Type
Experimental
Arm Description
Cannulation of the axillary artery.
Arm Title
Femoral artery.
Arm Type
Experimental
Arm Description
Cannulation of the femoral artery.
Intervention Type
Procedure
Intervention Name(s)
Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.
Intervention Description
Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.
Intervention Type
Procedure
Intervention Name(s)
Real-time ultrasound-guided out-of-plane femoral artery cannulation.
Intervention Description
Real-time ultrasound-guided out-of-plane femoral artery cannulation.
Primary Outcome Measure Information:
Title
Cannulation success rate
Description
The goal of the assessment of the cannulation success rate is essential for the estimation of the usefulness of both artery approaches in clinical practice.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Procedure complication rate.
Description
The goal of the assessment of the early mechanical complication rate is crucial for the estimation of the safety of both procedures in clinical practice.
Time Frame
24 hours
Title
Number of puncture attempts.
Description
The goal of the assessment is the evaluation which approach is easier to perform.
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 critically ill patients with indications for artery cannulation: in whom radial artery cannulation is unable to perform or in order to conduct hemodynamic monitoring using transpulmonary thermodilution Exclusion Criteria: age less than 18 years trauma and hematoma at the catheterization site clinically significant coagulation disorders infection at the catheterization site lack of patients or closest relatives contents precedent surgery operation into the femoral and axillary arteries clinically significant ischemia of the limb at the cannulation side
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryszard Gawda, 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
ZIP/Postal Code
45-401
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound-guided Axillary Artery vs Femoral Artery Cannulation.

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