Ultrasound-guided Axillary Artery vs Femoral Artery Cannulation.

Critical Illness Clinical Trial

— AxFemArt  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801825
• Other study ID #: AxFemArt
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: December 2021
• Source: Uniwersytecki Szpital Kliniczny w Opolu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Procedure:
• Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.
Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.
• Real-time ultrasound-guided out-of-plane femoral artery cannulation.
Real-time ultrasound-guided out-of-plane femoral artery cannulation.

Locations

Country	Name	City	State
Poland	Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu	Opole

Sponsors (1)

Lead Sponsor	Collaborator
Uniwersytecki Szpital Kliniczny w Opolu

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Secondary	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.	24 hours
Secondary	Number of puncture attempts.	The goal of the assessment is the evaluation which approach is easier to perform.	24 hours