Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients

Not Applicable

Recruiting

• Conditions: Arterial Catheterization
• Interventions: Procedure: Radial artery cannulation; Procedure: Ulnar artery cannulation

• Registration Number: NCT05258903
• Lead Sponsor: Brno University Hospital

Brief Summary

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

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.

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Study Timeline

• Study First Submitted: 2022-02-17
• Study First Submitted QC: 2022-02-17
• Study First Posted: 2022-02-28
• Study Start: 2022-05-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-27
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radial artery	Radial artery cannulation	Radial artery cannulation under USG-guidance
Ulnar artery	Ulnar artery cannulation	Ulnar artery cannulation under USG-guidance

Primary Outcome Measures

Name	Time	Method
overall puncture success in different arterial sites	intraoperatively	defined by number of required percutaneous punctures and overall site success rate

Secondary Outcome Measures

Name	Time	Method
Duration of catheterization	Intraoperatively	Time needed for successful catheterization
Interval between catheterization and catheter removal	24 hours postoperatively	Interval between catheterization and catheter removal will be evaluated
Technique of the ultrasound-guided cannulation (in-plane/out-of-plane)	intraoperatively	The USG guidance approach will be evaluated
Incidence of complications	24 hours postoperatively	Blood supply disorder, trophic changes, hematoma, arterial wall injury (aneurysm etc.), thrombosis.
Arteries anatomical description	intraoperatively	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.

Trial Locations

Locations (1)

Brno University Hospital; 🇨🇿 Brno, South Moravian Region, Czechia