Clinical trial NCT05258903: Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients
Official title: Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients: a Prospective Randomized Non-inferiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arterial Catheterization
Keywords: pediatric anesthesia
pediatric patient
Arterial catheterization
arterial catheter
ultrasound-guided cannulation
Arterial cannulation
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk University
First posted: 2022-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority randomized trial
Primary purpose: OTHER

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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Eligibility criteria: 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

Primary outcomes:
measure: overall puncture success in different arterial sites
timeFrame: intraoperatively
Secondary outcomes:
measure: Arteries anatomical description
timeFrame: intraoperatively
measure: Technique of the ultrasound-guided cannulation (in-plane/out-of-plane)
timeFrame: intraoperatively
measure: Incidence of complications
timeFrame: 24 hours postoperatively
measure: Duration of catheterization
timeFrame: Intraoperatively
measure: Interval between catheterization and catheter removal
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: South Moravian Region
Study officials:
affiliation: Department of paediatric anaesthesia and intensive care medicine
name: Petr Stourac, prof. MD., Ph.D., MBA
role: STUDY_CHAIR
References: