Femoral Arterial Cannulation in Pediatrics
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 12
SponsorAmerican University of Beirut Medical Center
About this trial
The goal of this clinical trial\] is to evaluate the efficacy and safety of 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 children. The main question it aims to answer is:
What is the time required for attempted femoral arterial cannulation by anesthesia residents at the first puncture site?
Researchers will compare the efficacy and safety of MDNTP-SAOP versus C-SAOP methods for femoral arterial cannulation performed by anesthesia residents in infants and children undergoing cardiac surgery.
Participants will be randomized to either the MDNTP-SAOP or the C-SAOP group. Intraoperatively, time taken for attempted cannulation by the resident at the first site of femoral arterial puncture, number of attempts at arterial cannulation, and number of cannulae required for successful cannula insertion will be recorded. Adverse events will be monitored on postoperative days 1 and 3. The insertion site will be examined for thrombosis, hematoma, infection, or limb ischemia distal to the insertion site
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Need for emergency surgery.
Hemodynamic instability.
Trial design
Design model
Parallel
Treatments tested in this trial
"Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP)
Procedure/SurgeryPatients will have their femoral arterial line inserted using the MDNTP-SAOP technique.
"Conventional, Short-Axis, Out-Of-Plane" (C-SAOP)
Procedure/SurgeryPatients will have their femoral arterial lines inserted using the C-SAOP technique.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP)Experimental treatment 1 intervention
Group B: "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time taken for attempted cannulation at the first site of femoral arterial puncture
Time to successful cannula insertion calculated from time of skin penetration until proper placement of the catheter confirmed by an arterial waveform measured in seconds.
Time frame
Intraoperative period: From time of skin penetration until proper placement of the catheterSecondary outcomes
1
Number of attempts at arterial cannulation
Defined as the number of needle advances through a new skin puncture or if the needle tip is completely withdrawn from the skin
Time frame
Intraoperative period: from the first needle puncture attempt until successful arterial cannulation is achieved.2
Number of successful cannulation on the first attempt
Number of successful cannulation on the first attempt
Time frame
Intraoperative period: assessed during the initial arterial cannulation attempt.3
Success rate
Success rate (defined as Yes=successful and No=not successful),
Time frame
Intraoperative period: assessed by the end of the arterial cannulation procedure.4
Number of cannulae required for successful cannula insertion
Number of cannulae required for successful cannula insertion
Time frame
Intraoperative period: recorded during the arterial cannulation procedure until successful insertion is achieved.Sponsors and contacts
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Source ClinicalTrials.gov