Arterial CatheterizationULNARTNCT05258903
Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients
A study testing Ulnar artery cannulation and Radial artery cannulation in people with Arterial Catheterization, run by Brno University Hospital at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Arterial Catheterization
- What is being tested?
- Ulnar artery cannulation and Radial artery cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- refused to participate
- arterial catheterization not clinically relevant
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Brno University Hospital
Brno, South Moravian, 62500
Petr Štourač, assoc.prof.MD.Ph.D., 532234404 ext. 00420, stourac.petr@fnbrno.cz
Jozef Klučka, MD, 532234696 ext. 00420, klucka.jozef@fnbrno.cz
About this study
Official title: 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.
Read the 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.
.
- Conditions
- Arterial Catheterization
- Being tested
- Ulnar artery cannulation, Radial artery cannulation
- Keywords
- pediatric anesthesia, pediatric patient, Arterial catheterization, arterial catheter, ultrasound-guided cannulation, Arterial cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulnar artery cannulationProcedure or surgery
Also called Ulnar artery catheterization
Ulnar artery will be cannulated under USG guidance
Radial artery cannulationProcedure or surgery
Also called Radial artery catheterization
Radial artery will be cannulated under USG guidance
| Study group | Role | What they receive |
|---|---|---|
| Ulnar artery | Experimental | Ulnar artery cannulation under USG-guidance Receives: Procedure: Ulnar artery cannulation |
| Radial artery | Active comparator | Radial artery cannulation under USG-guidance Receives: Procedure: Radial artery cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall puncture success in different arterial sites
defined by number of required percutaneous punctures and overall site success rate
Measured: intraoperatively
Secondary outcomes (5)
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.
Measured: intraoperatively
Technique of the ultrasound-guided cannulation (in-plane/out-of-plane)
The USG guidance approach will be evaluated
Measured: intraoperatively
Incidence of complications
Blood supply disorder, trophic changes, hematoma, arterial wall injury (aneurysm etc.), thrombosis.
Measured: 24 hours postoperatively
Duration of catheterization
Time needed for successful catheterization
Measured: Intraoperatively
Interval between catheterization and catheter removal
Interval between catheterization and catheter removal will be evaluated
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start1 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Stourac, prof. MD., Ph.D., MBA, Study chair, Department of paediatric anaesthesia and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258903
- Sponsor's protocol ID
- KDAR FN Brno Artery
- Acronym
- ULNART
- Status last verified
- Jul 2023
- First submitted
- 17 Feb 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ulnar Artery Versus Radial Artery Cannulation in Paediatric Patients: a Prospective Randomized Non-inferiority Study
- ClinicalTrials.gov ID
- NCT05258903
- Acronym / sponsor ID
- ULNART / KDAR FN Brno Artery
- Conditions
- Arterial Catheterization
- Keywords
- pediatric anesthesia, pediatric patient, Arterial catheterization, arterial catheter, ultrasound-guided cannulation, Arterial cannulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Non-inferiority randomized trial
| Arm | Type | Receives |
|---|---|---|
| Ulnar artery | Experimental | Procedure: Ulnar artery cannulationUlnar artery cannulation under USG-guidance |
| Radial artery | Active comparator | Procedure: Radial artery cannulationRadial artery cannulation under USG-guidance |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- refused to participate
- arterial catheterization not clinically relevant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulnar artery cannulationAlso: Ulnar artery catheterizationUlnar artery will be cannulated under USG guidance | Procedure or surgery | Ulnar artery |
| Radial artery cannulationAlso: Radial artery catheterizationRadial artery will be cannulated under USG guidance | Procedure or surgery | Radial artery |
Primary outcome
overall puncture success in different arterial sites
Time frame: intraoperatively
defined by number of required percutaneous punctures and overall site success rate
5 secondary outcomes
Arteries anatomical description
Time frame: intraoperatively
Technique of the ultrasound-guided cannulation (in-plane/out-of-plane)
Time frame: intraoperatively
Incidence of complications
Time frame: 24 hours postoperatively
Duration of catheterization
Time frame: Intraoperatively
Interval between catheterization and catheter removal
Time frame: 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Stourac, prof. MD., Ph.D., MBA study chair
Department of paediatric anaesthesia and intensive care medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulnar artery cannulation and Radial artery cannulation in people with Arterial Catheterization, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jozef UO Klučka, assoc.prof.MD., Ph.D. (+420532234696, klucka.jozef@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall puncture success in different arterial sites (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.