Ultrasound-guided Axillary Artery vs Femoral Artery Cannulation.

Study Overview
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Brief Summary
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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.

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

Conditions
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Critical Illness

Intervention / Treatment
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* Procedure: Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.
* Procedure: Real-time ultrasound-guided out-of-plane femoral artery cannulation.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of puncture attempts. | The goal of the assessment is the evaluation which approach is easier to perform. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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axillay artery, cannulation, femoral artery