Comparing two ultrasound methods for femoral artery access in children
Femoral Arterial Cannulation Performed by Anesthesia Residents: A Comparison Between Ultrasound-Guided "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" and "Conventional, Short-Axis, Out-Of-Plane" Methods
This trial tests whether a modified ultrasound technique helps anesthesia residents place femoral arterial lines faster and with fewer attempts in infants and children having heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | N/A to 12 Years |
| Sex | All |
| Sponsor | American University of Beirut Medical Center Academic / other |
| Locations | 1 site (Beirut) |
| Trial ID | NCT07059624 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blinded trial will enroll 80 children under age 12 undergoing cardiac surgery and without existing arterial access, assigning them to either the Modified Dynamic Needle Tip Positioning Short-Axis Out-Of-Plane (MDNTP-SAOP) or the Conventional Short-Axis Out-Of-Plane (C-SAOP) ultrasound technique. Anesthesia residents will perform femoral arterial cannulation intraoperatively while investigators measure time to successful cannulation at the first puncture site, number of attempts, cannulae used, and complications such as hematoma or thrombosis. Patients and outcome assessors are blinded to group allocation, while the performing residents are not. The trial compares procedural efficiency and safety between the two ultrasound-guided approaches in the pediatric cardiac surgery setting.
Who should consider this trial
Good fit: Infants and children under 12 years old with congenital heart disease scheduled for planned cardiac surgery (ASA II–IV) who do not already have arterial line access are ideal candidates.
Not a fit: Children needing emergency surgery, those who are hemodynamically unstable, older than 12 years, or who already have femoral arterial access are unlikely to benefit from enrolling.
Why it matters
Potential benefit: If successful, the modified technique could shorten cannulation time and reduce attempts and complications, lowering procedural risk for children needing femoral arterial access.
How similar studies have performed: Ultrasound guidance in pediatric vascular access has improved success versus palpation, and dynamic needle-tip techniques have shown benefits in other vascular access studies, but direct pediatric comparisons of MDNTP-SAOP versus C-SAOP are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants and children under 12 years of age. * American Society of Anesthesiologist (ASA) physical status II-IV. * Patients with congenital heart disease undergoing cardiac surgery who do not have existing arterial line access. Exclusion Criteria: * Need for emergency surgery. * Hemodynamic instability.
Where this trial is running
Beirut
- American University of Beirut Medical Center — Beirut, Lebanon (Recruiting)
Study contacts
- Principal investigator: Amro Khalili, MD — American University of Beirut Medical Center
- Study coordinator: Amro Khalili, MD
- Email: ak151@aub.edu.lb
- Phone: 01350000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.