Arterial CatheterizationNCT07890779
Ultrasound-Guided Ulnar Versus Radial Artery Cannulation in Children
A study testing Radial artery cannulation and Ulnar artery cannulation in people with Arterial Catheterization and Hemodynamic Monitoring, run by Tunis University at 1 site in Tunisia.
Trial summary
Arterial catheterization provides continuous blood pressure monitoring and repeated blood sampling in children undergoing surgery at high cardiovascular or hemorrhagic risk, and in critically ill children. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Arterial Catheterization, Hemodynamic Monitoring, Pediatrics
- What is being tested?
- Radial artery cannulation and Ulnar artery cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Jan 2024to 1 Sep 2024
- Phase
- Interventional
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age older than one year - American Society of Anesthesiologists physical status I to III - Need for invasive arterial pressure monitoring during elective surgery or in the intensive care unit - Written informed consent from the legal guardian
Who cannot join
- Refusal or unavailability of the legal guardian at the time of the pre-anesthetic assessment - Arterial catheterization at the same site within the preceding month - Contraindication to arterial catheterization: inflammatory, ischemic or infectious lesions of both upper limbs, dialysis fistula - Abnormal Allen test - Hemostatic disorder - Treatment with catecholamines above 0.1 microgram per kilogram per minute - Wrist arterial malformation identified at sonographic screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Radial Versus Ulnar Arterial Cannulation in Children: a Single-Center, Single-Blind Randomized Controlled Trial
Arterial catheterization provides continuous blood pressure monitoring and repeated blood sampling in children undergoing surgery at high cardiovascular or hemorrhagic risk, and in critically ill children. The radial artery is the conventional site, but cannulation remains challenging in children because of small vessel caliber and frequent anatomical variants. Ultrasound guidance has made alternative sites accessible, and the ulnar artery has a comparable caliber and a depth often closer to the range considered optimal for puncture. This trial compared ultrasound-guided ulnar versus radial arterial cannulation in children older than one year, with regard to first-attempt success and the rate of local complications.
Read the detailed description
Children older than one year, of ASA physical status I to III, requiring invasive arterial pressure monitoring for elective surgery or in the intensive care unit, were randomly assigned in a 1:1 ratio to cannulation of the radial artery (group R) or the ulnar artery (group U). The allocation sequence was computer-generated and applied by an investigator not involved in the puncture, after sedation had been established. Patients and their legal guardians remained unaware of the allocated site; operators could not be blinded. The allocated artery was screened sonographically before puncture to exclude thrombosis or anatomical variants, and its diameter and depth were measured. The wrist was placed in 45 degrees of dorsiflexion. The artery was punctured on the anterior aspect of the wrist through a short-axis out-of-plane approach, using a 25-gauge 4 cm catheter and a 6-13 MHz linear probe, by anesthesia residents in their seventh semester of training or beyond under direct senior supervision. An attempt was considered failed when a large hematoma or arterial spasm occurred; cannulation was then reattempted at the same arterial site on the contralateral limb, and the supervising senior physician took over in case of persistent failure.
- Conditions
- Arterial Catheterization, Hemodynamic Monitoring, Pediatrics
- Being tested
- Radial artery cannulation, Ulnar artery cannulation
- Keywords
- ulnar artery, radial artery, arterial cannulation, ultrasound guidance, out-of-plane, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial artery cannulationProcedure or surgery
The radial artery is identified sonographically at the anterior aspect of the wrist and confirmed with Doppler, with the wrist in 45 degrees of dorsiflexion. It is punctured through a short-axis out-of-plane approach using a 25-gauge 4 cm catheter and a Sonosite M-Turbo system with a 6-13 MHz linear probe.
Ulnar artery cannulationProcedure or surgery
Identical procedure applied to the ulnar artery.
| Study group | Role | What they receive |
|---|---|---|
| Radial artery (Group R) | Active comparator | Ultrasound-guided cannulation of the radial artery through a short-axis out-of-plane approach. Receives: Procedure: Radial artery cannulation |
| Ulnar artery (Group U) | Experimental | Ultrasound-guided cannulation of the ulnar artery through a short-axis out-of-plane approach. Receives: Procedure: Ulnar artery cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful arterial cannulation at the first attempt
Proportion of patients in whom an arterial pressure waveform was obtained on the monitor at the first puncture attempt
Measured: During the cannulation procedure, up to 15 minutes from skin puncture
Secondary outcomes (6)
Artery localization time
Measured: During the cannulation procedure, up to 15 minutes
Catheter insertion time
Measured: During the cannulation procedure, up to 15 minutes
Total procedure time
Measured: During the cannulation procedure, up to 15 minutes
Number of puncture attempts
Measured: During the cannulation procedure, up to 15 minutes
Need for a second operator
Measured: During the cannulation procedure, up to 15 minutes
Incidence of local complications
Measured: From the cannulation procedure until catheter removal, up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Jan 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Trifa, Tunis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890779
- Sponsor's protocol ID
- 20/2022
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No