Pediatric ALLNCT07059624
Femoral Arterial Cannulation in Pediatrics
A study testing "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP) and "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP) in people with Pediatric ALL and Cardiac Complication, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric ALL, Cardiac Complication, Anesthesia
- What is being tested?
- "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP) and "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteLebanon
- Study dates
- 9 Jul 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Need for emergency surgery.
- Hemodynamic instability.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site, 1 recruiting
- Recruiting
American University of Beirut Medical Center
Beirut
Amro Khalili, MD, ak151@aub.edu.lb
About this study
Official title: 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
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:
Read more
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
Read the detailed description
Background: Arterial cannulation in infants and children can be challenging, even for the most experienced provider. The femoral artery, preferred over the radial artery for its size and stronger pulsation, serves as the access site in infants and children undergoing cardiac surgery at our institution. While ultrasound-guided techniques have improved cannulation success compared to the conventional palpation technique, there is limited comparative research on different ultrasound-guided methods, namely "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP) method versus "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP) method, specifically for the pediatric age group, done by anesthesia residents.
Specific Aims: This study aims to evaluate the efficacy and safety of the ultrasound-guided MDNTP-SAOP technique compared to the C-SAOP technique for femoral arterial cannulation performed by anesthesia residents in children. The primary objective is to measure the time taken for successful cannulation at the first femoral arterial puncture site, with secondary outcomes assessing the number of attempts, first-attempt success rates, total cannulae used, and complications such as hematoma or thrombosis.
Methods: This prospective randomized controlled trial will include 80 children under 12 years of age scheduled for cardiac surgery. Participants will be randomized to either the MDNTP-SAOP or the C-SAOP group. This study will be double-blinded: Patients and research members will be blinded to the group allocation. 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.
Analysis: Statistical analysis will involve continuous variables reported as means with standard deviations and analyzed using t-tests, while categorical data will be summarized as counts and percentages and examined using chi-square or Fisher's exact tests where appropriate. Non-parametric data, such as the number of attempts, will be reported as median and range. The significance level will be set at p < 0.05. The cumulative success percentage and time to successful cannulation will be analyzed using Kaplan-Meier survival curves and compared between groups using log-rank tests.
Significance: If the MDNTP-SAOP technique demonstrates a significantly shorter time to successful cannulation and lower complication rates relative to the C-SAOP method, it may provide a new standard for training anesthesia residents in the pediatric age group. This could ultimately enhance patient safety and improve clinical outcomes in pediatric cardiac surgery.
- Conditions
- Pediatric ALL, Cardiac Complication, Anesthesia
- Being tested
- "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP), "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP)Procedure or surgery
Patients will have their femoral arterial line inserted using the MDNTP-SAOP technique.
"Conventional, Short-Axis, Out-Of-Plane" (C-SAOP)Procedure or surgery
Patients will have their femoral arterial lines inserted using the C-SAOP technique.
| Study group | Role | What they receive |
|---|---|---|
| "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. Receives: 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. Receives: Procedure: "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative period: From time of skin penetration until proper placement of the catheter
Secondary outcomes (4)
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
Measured: Intraoperative period: from the first needle puncture attempt until successful arterial cannulation is achieved.
Number of successful cannulation on the first attempt
Number of successful cannulation on the first attempt
Measured: Intraoperative period: assessed during the initial arterial cannulation attempt.
Success rate
Success rate (defined as Yes=successful and No=not successful),
Measured: Intraoperative period: assessed by the end of the arterial cannulation procedure.
Number of cannulae required for successful cannula insertion
Number of cannulae required for successful cannula insertion
Measured: Intraoperative period: recorded during the arterial cannulation procedure until successful insertion is achieved.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start9 Jul 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amro Khalili, American University of Beirut Medical Center
- Investigators
- Amro Khalili, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059624
- Sponsor's protocol ID
- BIO-2025-0163
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07059624
- Acronym / sponsor ID
- BIO-2025-0163
- Conditions
- Pediatric ALL, Cardiac Complication, Anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Background: Arterial cannulation in infants and children can be challenging, even for the most experienced provider. The femoral artery, preferred over the radial artery for its size and stronger pulsation, serves as the access site in infants and children undergoing cardiac surgery at our institution. While ultrasound-guided techniques have improved cannulation success compared to the conventional palpation technique, there is limited comparative research on different ultrasound-guided methods, namely "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP) method versus "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP) method, specifically for the pediatric age group, done by anesthesia residents.
Specific Aims: This study aims to evaluate the efficacy and safety of the ultrasound-guided MDNTP-SAOP technique compared to the C-SAOP technique for femoral arterial cannulation performed by anesthesia residents in children. The primary objective is to measure the time taken for successful cannulation at the first femoral arterial puncture site, with secondary outcomes assessing the number of attempts, first-attempt success rates, total cannulae used, and complications such as hematoma or thrombosis.
Methods: This prospective randomized controlled trial will include 80 children under 12 years of age scheduled for cardiac surgery. Participants will be randomized to either the MDNTP-SAOP or the C-SAOP group. This study will be double-blinded: Patients and research members will be blinded to the group allocation. 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.
Analysis: Statistical analysis will involve continuous variables reported as means with standard deviations and analyzed using t-tests, while categorical data will be summarized as counts and percentages and examined using chi-square or Fisher's exact tests where appropriate. Non-parametric data, such as the number of attempts, will be reported as median and range. The significance level will be set at p < 0.05. The cumulative success percentage and time to successful cannulation will be analyzed using Kaplan-Meier survival curves and compared between groups using log-rank tests.
Significance: If the MDNTP-SAOP technique demonstrates a significantly shorter time to successful cannulation and lower complication rates relative to the C-SAOP method, it may provide a new standard for training anesthesia residents in the pediatric age group. This could ultimately enhance patient safety and improve clinical outcomes in pediatric cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP) | Experimental | Procedure: "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP)Patients will have their femoral arterial line inserted using the MDNTP-SAOP technique. |
| "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP) | Active comparator | Procedure: "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP)Patients will have their femoral arterial lines inserted using the C-SAOP technique. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Need for emergency surgery.
- Hemodynamic instability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP)Patients will have their femoral arterial line inserted using the MDNTP-SAOP technique. | Procedure or surgery | "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP) |
| "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP)Patients will have their femoral arterial lines inserted using the C-SAOP technique. | Procedure or surgery | "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP) |
Primary outcome
Time taken for attempted cannulation at the first site of femoral arterial puncture
Time frame: Intraoperative period: From time of skin penetration until proper placement of the catheter
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.
4 secondary outcomes
Number of attempts at arterial cannulation
Time frame: Intraoperative period: from the first needle puncture attempt until successful arterial cannulation is achieved.
Number of successful cannulation on the first attempt
Time frame: Intraoperative period: assessed during the initial arterial cannulation attempt.
Success rate
Time frame: Intraoperative period: assessed by the end of the arterial cannulation procedure.
Number of cannulae required for successful cannula insertion
Time frame: Intraoperative period: recorded during the arterial cannulation procedure until successful insertion is achieved.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amro Khalili, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Modified Dynamic Needle Tip Positioning, Short-Axis, Out-Of-Plane" (MDNTP-SAOP) and "Conventional, Short-Axis, Out-Of-Plane" (C-SAOP) in people with Pediatric ALL and Cardiac Complication, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amro Khalili, MD (01350000 ext. 6820, ak151@aub.edu.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time taken for attempted cannulation at the first site of femoral arterial puncture (time frame: Intraoperative period: From time of skin penetration until proper placement of the catheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.