Actively Recruiting

Phase Not Applicable
Age: 0 - 12Years
All Genders
Healthy Volunteers
ID07059624

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

Led by American University of Beirut Medical Center · Updated on 2025-07-20

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the ultrasound-guided "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP) technique compared to the "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP) technique for femoral arterial cannulation performed by anesthesia residents in infants and children undergoing cardiac surgery. The study aims to find out which method requires less time for successful cannulation at the first puncture site and to assess safety and efficacy in this pediatric population. Participants under 12 years old will be randomly assigned to receive femoral arterial cannulation using either the MDNTP-SAOP method or the C-SAOP method. Both groups will undergo the procedure during surgery, and the study is double-blinded, meaning patients and research staff will not know which technique is used. The procedures will be performed by anesthesia residents, and data on time taken for cannulation, number of attempts, success rates, and number of cannulae used will be collected. Throughout the study, researchers will monitor participants for adverse events such as thrombosis, hematoma, infection, or limb ischemia at the insertion site on the first and third days after surgery. The main measure is the time from skin penetration to proper catheter placement during the operation. The study will also record the number of attempts and success rates during the procedure. The trial will continue until January 2027 with careful safety and outcome monitoring.

CONDITIONS

Brief Title

Femoral Arterial Cannulation in Pediatrics

Who Can Participate

Age: 0 - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 without existing arterial line access
Not Eligible

You will not qualify if you...

  • Need for emergency surgery
  • Hemodynamic instability

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - During cardiac surgery procedure

Participants undergo femoral arterial cannulation using one of two ultrasound-guided techniques performed by anesthesia residents during cardiac surgery.

1 intraoperative procedure visit

Follow-up

Duration - 3 days post-surgery

Participants are monitored for adverse events such as hematoma, thrombosis, infection, or limb ischemia at the insertion site on postoperative days 1 and 3.

2 post-operative visits (on days 1 and 3)

Trial Site Locations

Total: 1 location

1

American University of Beirut Medical Center

Beirut, Lebanon

Actively Recruiting

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Research Team

A

Amro Khalili, MD

T

Thouraya HajAli, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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