Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients (ULNART)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Arterial Catheterization
• Intervention / Treatment: Procedure: Ulnar artery cannulation; Procedure: Radial artery cannulation

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jozef UO Klučka, assoc.prof.MD., Ph.D.; Phone Number: +420532234696; Email: klucka.jozef@fnbrno.cz
• Study Contact Backup: Name: Václav Vafek, MD; Phone Number: +420532234696; Email: Vafek.Vaclav@fnbrno.cz

Study Locations

• Czechia
  • South Moravian Region
    • Brno, South Moravian Region, Czechia, 62500
      • Recruiting
      • Brno University Hospital
      • Contact: Jozef Klučka, MD; Phone Number: 00420 532234696; Email: klucka.jozef@fnbrno.cz
      • Contact: Petr Štourač, assoc.prof.MD.Ph.D.; Phone Number: 00420 532234404; Email: stourac.petr@fnbrno.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 6 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ulnar artery; Ulnar artery cannulation under USG-guidance	Procedure: Ulnar artery cannulation; Ulnar artery will be cannulated under USG guidance; Other Names: Ulnar artery catheterization
Active Comparator: Radial artery; Radial artery cannulation under USG-guidance	Procedure: Radial artery cannulation; Radial artery will be cannulated under USG guidance; Other Names: Radial artery catheterization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Collaborators: Masaryk University
• Investigators: Study Chair: Petr Stourac, prof. MD., Ph.D., MBA, Department of paediatric anaesthesia and intensive care medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: pediatric anesthesia; pediatric patient; Arterial catheterization; arterial catheter; ultrasound-guided cannulation; Arterial cannulation
• Other Study ID Numbers: KDAR FN Brno Artery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No