Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients

Arterial Catheterization Clinical Trial

— ULNART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05258903
• Other study ID #: KDAR FN Brno Artery
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Brno University Hospital
• Contact: Jozef UO Klucka, assoc.prof.MD., Ph.D.
• Phone: +420532234696
• Email: klucka.jozef[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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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Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Catheterization

Intervention

Procedure:
• Ulnar artery cannulation
Ulnar artery will be cannulated under USG guidance
• Radial artery cannulation
Radial artery will be cannulated under USG guidance

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno	South Moravian Region

Sponsors (2)

Lead Sponsor	Collaborator
Brno University Hospital	Masaryk University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall puncture success in different arterial sites	defined by number of required percutaneous punctures and overall site success rate	intraoperatively
Secondary	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
Secondary	Technique of the ultrasound-guided cannulation (in-plane/out-of-plane)	The USG guidance approach will be evaluated	intraoperatively
Secondary	Incidence of complications	Blood supply disorder, trophic changes, hematoma, arterial wall injury (aneurysm etc.), thrombosis.	24 hours postoperatively
Secondary	Duration of catheterization	Time needed for successful catheterization	Intraoperatively
Secondary	Interval between catheterization and catheter removal	Interval between catheterization and catheter removal will be evaluated	24 hours postoperatively