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Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05258903
Acronym
ULNART
Enrollment
100
Registered
2022-02-28
Start date
2022-05-01
Completion date
2023-12-31
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Catheterization

Keywords

pediatric anesthesia, pediatric patient, Arterial catheterization, arterial catheter, ultrasound-guided cannulation, Arterial cannulation

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. .

Interventions

PROCEDUREUlnar artery cannulation

Ulnar artery will be cannulated under USG guidance

PROCEDURERadial artery cannulation

Radial artery will be cannulated under USG guidance

Sponsors

Masaryk University
CollaboratorOTHER
Brno University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

randomization after general anesthesia induction, or deep sedation in PICU

Intervention model description

Non-inferiority randomized trial

Eligibility

Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
overall puncture success in different arterial sitesintraoperativelydefined by number of required percutaneous punctures and overall site success rate

Secondary

MeasureTime frameDescription
Arteries anatomical descriptionintraoperativelyDefined 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.
Technique of the ultrasound-guided cannulation (in-plane/out-of-plane)intraoperativelyThe USG guidance approach will be evaluated
Incidence of complications24 hours postoperativelyBlood supply disorder, trophic changes, hematoma, arterial wall injury (aneurysm etc.), thrombosis.
Duration of catheterizationIntraoperativelyTime needed for successful catheterization
Interval between catheterization and catheter removal24 hours postoperativelyInterval between catheterization and catheter removal will be evaluated

Countries

Czechia

Contacts

Primary ContactJozef UO Klučka, assoc.prof.MD., Ph.D.
klucka.jozef@fnbrno.cz+420532234696
Backup ContactVáclav Vafek, MD
Vafek.Vaclav@fnbrno.cz+420532234696

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026