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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05258903
Other study ID # KDAR FN Brno Artery
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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. .


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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02912481 - Posterior Tibial Artery Catheterization N/A
Completed NCT01494311 - Rapydan Topical Anaesthesia for Arterial Cannulation Phase 4
Completed NCT02333786 - Ultrasound-guided Arterial Catheterization in Pediatric Patients N/A
Completed NCT05687370 - Modified Dynamic Needle Tip Positioning vs Conventional Long-axis In-plane in Radial Artery Cannulation N/A