NCT05258903

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

February 17, 2022

Last Update Submit

July 26, 2023

Conditions

Arterial Catheterization

Keywords

pediatric anesthesiapediatric patientArterial catheterizationarterial catheterultrasound-guided cannulationArterial cannulation

Outcome Measures

Primary Outcomes (1)

  • overall puncture success in different arterial sites

    defined by number of required percutaneous punctures and overall site success rate

    intraoperatively

Secondary Outcomes (5)

  • Arteries anatomical description

    intraoperatively

  • Technique of the ultrasound-guided cannulation (in-plane/out-of-plane)

    intraoperatively

  • Incidence of complications

    24 hours postoperatively

  • Duration of catheterization

    Intraoperatively

  • Interval between catheterization and catheter removal

    24 hours postoperatively

Study Arms (2)

Ulnar artery

EXPERIMENTAL

Ulnar artery cannulation under USG-guidance

Procedure: Ulnar artery cannulation

Radial artery

ACTIVE COMPARATOR

Radial artery cannulation under USG-guidance

Procedure: Radial artery cannulation

Interventions

Ulnar artery cannulationPROCEDURE

Ulnar artery will be cannulated under USG guidance

Also known as: Ulnar artery catheterization
Ulnar artery
Radial artery cannulationPROCEDURE

Radial artery will be cannulated under USG guidance

Also known as: Radial artery catheterization
Radial artery

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • refused to participate
  • arterial catheterization not clinically relevant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

RECRUITING

Study Officials

  • Petr Stourac, prof. MD., Ph.D., MBA

    Department of paediatric anaesthesia and intensive care medicine

    STUDY CHAIR

Central Study Contacts

Jozef UO Klučka, assoc.prof.MD., Ph.D.

CONTACT

+420532234696klucka.jozef@fnbrno.cz

Václav Vafek, MD

CONTACT

+420532234696Vafek.Vaclav@fnbrno.cz

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
randomization after general anesthesia induction, or deep sedation in PICU
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Non-inferiority randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 17, 2022

First Posted

February 28, 2022

Study Start

May 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

CZ(1)