Ultrasound-Guided Radial Versus Ulnar Arterial Cannulation in Children: a Single-Center, Single-Blind Randomized Controlled Trial
| Registry | NCT07890779 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, diagnostic |
| Enrollment | 85 (Actual) |
| Sponsor | Tunis University (Other) |
| Conditions | Arterial Catheterization, Hemodynamic Monitoring, Pediatrics |
| Interventions | Radial artery cannulation, Ulnar artery cannulation (Procedure) |
| Dates | start 2024-01-01, primary completion 2024-09-01, completion 2024-09-01, first posted 2026-10-22, last updated 2026-10-22 |
| Locations | 1 site in Tunisia |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Radial artery (Group R) | Active comparator | Procedure: Radial artery cannulation | Ultrasound-guided cannulation of the radial artery through a short-axis out-of-plane approach. |
| Ulnar artery (Group U) | Experimental | Procedure: Ulnar artery cannulation | Ultrasound-guided cannulation of the ulnar artery through a short-axis out-of-plane approach. |
Sex: All, ages: 1 Year to 18 Years
Inclusion Criteria: * 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 Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| Bechir Hamza Children's Hospital, Tunis 1029 | Tunis | Tunisia |