Femoral Arterial Cannulation in Pediatrics

NCT07059624 | Recruiting

• 1 other identifier: BIO-2025-0163
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pediatric ALL; Cardiac Complication; Anesthesia

Outcome Measures

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.

  Intraoperative period: From time of skin penetration until proper placement of the catheter

Secondary Outcomes (4)

• Number of attempts at arterial cannulation

  Intraoperative period: from the first needle puncture attempt until successful arterial cannulation is achieved.

• Number of successful cannulation on the first attempt

  Intraoperative period: assessed during the initial arterial cannulation attempt.

• Success rate

  Intraoperative period: assessed by the end of the arterial cannulation procedure.

• Number of cannulae required for successful cannula insertion

  Intraoperative period: recorded during the arterial cannulation procedure until successful insertion is achieved.

Study Arms (2)

"Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP)

EXPERIMENTAL

Patients will have their femoral arterial line inserted using the MDNTP-SAOP technique.

Procedure: "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP)

"Conventional, Short-Axis, Out-Of-Plane" (C-SAOP)

ACTIVE COMPARATOR

Patients will have their femoral arterial lines inserted using the C-SAOP technique.

Procedure: "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP)

Interventions

"Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP) PROCEDURE

Patients will have their femoral arterial line inserted using the MDNTP-SAOP technique.

"Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP)

"Conventional, Short-Axis, Out-Of-Plane" (C-SAOP) PROCEDURE

Patients will have their femoral arterial lines inserted using the C-SAOP technique.

"Conventional, Short-Axis, Out-Of-Plane" (C-SAOP)

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Need for emergency surgery.
• Hemodynamic instability.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Amro Khalili, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amro Khalili, MD

CONTACT

01350000; ak151@aub.edu.lb

Thouraya HajAli, MSc

CONTACT

01350000; th64@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This study will be double-blinded: Patients and research members will be blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 11, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)