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

December 19, 2021 updated by: Ryszard Gawda, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu

A Randomized Study of Ultrasound-guided Axillary and Femoral Artery Cannulation in Mechanically Ventilated Critically Ill Patients.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Opole, Poland, 45-401
        • Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Axillary artery.
Cannulation of the axillary artery.
Procedure: Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.
Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.
Experimental: Femoral artery.
Cannulation of the femoral artery.
Procedure: Real-time ultrasound-guided out-of-plane femoral artery cannulation.
Real-time ultrasound-guided out-of-plane femoral artery cannulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cannulation success rate
Time Frame: 24 hours
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure complication rate.
Time Frame: 24 hours
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.
24 hours
Number of puncture attempts.
Time Frame: 24 hours
The goal of the assessment is the evaluation which approach is easier to perform.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniwersytecki Szpital Kliniczny w Opolu

Investigators

  • Principal Investigator: Ryszard Gawda, MD PhD, Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2018

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 12, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 19, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AxFemArt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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