Actively Recruiting
Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children - Open-label Randomized Trial
Led by Medical University of Warsaw · Updated on 2025-07-30
120
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how using ultrasound imaging of the lumbar spinal canal affects the success of lumbar punctures in children under 18 years old. Lumbar puncture is often done to rule out infections like meningitis and encephalitis in pediatric patients. Challenges such as young age, difficulty feeling anatomical landmarks, lack of local anesthesia, practitioner experience, and patient movement can impact the procedure's success. Ultrasound before the puncture may help visualize key spinal structures and improve accuracy, especially for less experienced doctors. Participants will be randomly assigned to one of two groups: an ultrasound group or a standard group. In the ultrasound group, a bedside ultrasound exam using a Lumify linear probe will be done before the lumbar puncture to mark safe and optimal puncture sites and measure depth to the dura mater. This information is shared with the doctor performing the puncture. The standard group will undergo lumbar puncture guided only by palpation without ultrasound. Procedure time and ultrasound exam time will be recorded. Children under 18 undergoing lumbar puncture will have their procedure details recorded, including success after the first attempt and total attempts, cerebrospinal fluid quality, and duration of the procedure. Doctors will complete questionnaires about their experience. Researchers will assess how ultrasound imaging impacts lumbar puncture success, considering the doctor's experience and the child's body mass index. The study will monitor outcomes within one day after the procedure to evaluate effectiveness and safety.
CONDITIONS
Brief Title
Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children under 18 years of age
- Scheduled to undergo lumbar puncture
- Consent provided by legal guardian
You will not qualify if you...
- Infection of skin or tissues near planned puncture site
- Developmental defects of the spine or spinal cord
- Lack of consent from legal guardian
- Contraindications to lumbar puncture
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo either a bedside ultrasound examination of the lumbar spinal canal or the standard lumbar puncture procedure without ultrasound before the lumbar puncture is performed.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Medcial Univeristy of Warsaw
Warsaw, Poland, 02-091
Actively Recruiting
Research Team
A
Agata - Ćwiek, MD
M
Maciej - Kołodziej, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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