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Completed

NCT Number: NCT02801825

Ultrasound-guided Axillary Artery vs Femoral Artery Cannulation.

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.

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Key information

Conditions

Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Opole, 45-401, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.

Procedure

Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.

Real-time ultrasound-guided out-of-plane femoral artery cannulation.

Procedure

Real-time ultrasound-guided out-of-plane femoral artery cannulation.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Number of puncture attempts.

    Time frame: 24 hours

    The goal of the assessment is the evaluation which approach is easier to perform.

Sponsors and collaborators

Lead sponsor

Uniwersytecki Szpital Kliniczny w Opolu

Other

Registry information

Official study title

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

Acronym: AxFemArt

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jun 16, 2016
Registry last updated
Dec 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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