Actively Recruiting

Phase Not Applicable
Age: 0 - 18Years
All Genders
ID06584864

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

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children under 18 years of age
  • Scheduled to undergo lumbar puncture
  • Consent provided by legal guardian
Not Eligible

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

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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)

Diagnostic Evaluation

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

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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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