Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients

Study Overview
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Brief Summary
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Arterial cannulation is indicated in several clinical settings: high-risk surgery, respiratory failure, circulatory failure. The possible anatomical sites of cannulation are: a.radialis, a.brachialis, a. femoralis. However, the most reported complications in preschool-aged children are associated with femoral and brachial arteries. Therefore, alternative cannulation sites are being searched as ulnar artery, tibial posterior artery.

Detailed Description
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In pediatric patients, artery cannulation may be associated with a higher risk of complications. The preferred puncture site is the radial artery or the femoral artery. However, puncture of the femoral artery in comparison with the radial artery is based on observational data as a significant risk side of post-puncture complications. The radial artery is the dominant artery of the hand, and the collateral supply (via the ulnar artery) is often unable to provide adequate peripheral perfusion. Therefore, other potential sites suitable for artery cannulation in paediatric patients are currently being investigated with the primary goal of increasing safety and reducing the risk of post-puncture complications. According to published studies, the potential alternatives are: posterior tibial artery and ulnar artery. Both arteries have comparable dimensions with radial artery and can be used for USG-guided cannulation. In this prospective randomized trial, patients with clinical indication for arterial cannulation (high-risk surgery, respiratory failure, circulatory failure) undergoing surgery under general anesthesia and pediatric patients admitted into the pediatric intensive care unit (PICU) will be randomized in form of sealed envelopes into a.radialis and a.ulnaris group as the initial site of arterial catheterization. Ultrasound (USG) measurement of both arteries will be performed before the cannulation. The catheterization success rate (number of percutaneous punctures) and overall success rate will be evaluated. The artery will be cannulated under USG control, initially in in-plane view, only in case of insufficient image, or after 2 unsuccessful attempts, the out-of-plane approach could be used. The maximum 5 percutaneous attempts and 10 minutes could be used for the initial (randomized) site of cannulation). In case of cannulation failure, the other artery could be used for cannulation. The rate of complications in 24 hours after cannulation will be evaluated. The arterial catheter will stay in place until the clinical indication remained. .

Official Title
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Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients: a Prospective Randomized Non-inferiority Study

Conditions
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Arterial Catheterization

Intervention / Treatment
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* Procedure: Ulnar artery cannulation
* Procedure: Radial artery cannulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Paediatric patients (1 - 6 years) high risk surgery (significant blood loss or hemodynamic instability) critically ill patients at PICU (respiratory failure, circulatory failure) informed consent Exclusion Criteria: refused to participate arterial catheterization not clinically relevant

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 6 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-inferiority randomized trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulnar artery<br>Ulnar artery cannulation under USG-guidance | Procedure: Ulnar artery cannulation<br>* Ulnar artery will be cannulated under USG guidance<br>* Other names: Ulnar artery catheterization;|
| Active Comparator: Radial artery<br>Radial artery cannulation under USG-guidance | Procedure: Radial artery cannulation<br>* Radial artery will be cannulated under USG guidance<br>* Other names: Radial artery catheterization;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall puncture success in different arterial sites | defined by number of required percutaneous punctures and overall site success rate | intraoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arteries anatomical description | Defined by USG measurement of depth of the artery - (distance from the skin to the upper wall of the artery), cross-sectional area, diameter of the artery. | intraoperatively | 
| Technique of the ultrasound-guided cannulation (in-plane/out-of-plane) | The USG guidance approach will be evaluated | intraoperatively | 
| Incidence of complications | Blood supply disorder, trophic changes, hematoma, arterial wall injury (aneurysm etc.), thrombosis. | 24 hours postoperatively | 
| Duration of catheterization | Time needed for successful catheterization | Intraoperatively | 
| Interval between catheterization and catheter removal | Interval between catheterization and catheter removal will be evaluated | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric anesthesia, pediatric patient, Arterial catheterization, arterial catheter, ultrasound-guided cannulation, Arterial cannulation