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MeningitisNCT06584864

Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children.

A study testing bedside ultrasound examination of the lumbar spinal canal in people with Meningitis and Pediatric Disorder, run by Medical University of Warsaw at 1 site in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of the study is to assess the influence of ultrasound examination of the lumbar spinal canal on the effectiveness of lumbar puncture. An open-label, randomized interventional study. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Meningitis, Pediatric Disorder
What is being tested?
bedside ultrasound examination of the lumbar spinal canal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 sitePoland
Study dates
1 Mar 2024to 1 Jun 2026
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 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • children <18 years of age
  • patients who are scheduled to undergo lumbar puncture
  • consent of legal guardian

Who cannot join

  • infection of skin and tissues in the area of planned puncture
  • developmental defects of the spine and spinal cord
  • lack of consent of legal guardian
  • contraindications to lumbar puncture

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Agata - Ćwiek, MD contact

22-317-95-37

agata.cwiek@uckwum.pl

Maciej - Kołodziej, MD contact

22-317-95-37

maciej.kolodziej@uckwum.pl

Poland1 site, 1 recruiting
  • Medcial Univeristy of Warsaw

    Warsaw, 02-091

    Agata - Ćwiek, MD, 22-317-95-37, agata.cwiek@uckwum.pl

    Maciej - Kołodziej, MD, 22-317-95-37, maciej.kolodziej@uckwum.pl

    Recruiting

Other trials in Poland

About this study

Official title: Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children - Open-label Randomized Trial

The aim of the study is to assess the influence of ultrasound examination of the lumbar spinal canal on the effectiveness of lumbar puncture. An open-label, randomized interventional study.

Read the detailed description

Lumbar puncture is a common procedure performed in pediatric departments. The most common purpose of the examination in the pediatric patient population is to exclude infectious diseases of the central nervous system: meningitis and encephalitis. Risk factors for traumatic or unsuccessful puncture include, among others: patient age less than 3 months, difficulty in identifying anatomical structures by palpation, lack of local anesthesia, lack of experience of the person performing the procedure, and patient movement during puncture. The use of spinal canal ultrasonography before performing lumbar puncture brings promising benefits. Ultrasound imaging can be helpful in visualizing key anatomical structures within the spinal canal and increasing the certainty of correct performance of the procedure, especially in inexperienced physicians.

The study objective is to assess the effect of ultrasound imaging of the lumbar spinal canal on the effectiveness of lumbar puncture.

We plan to include every child <18 years old with an indication for lumbar puncture to the one of the two groups (ultrasound group and standard group)

Before the procedure, doctors performing the lumbar puncture in both groups will complete a questionnaire regarding their previous experience In the USG group, before performing the lumbar puncture, one of the two researchers will perform a bedside ultrasound examination of the lumbar spinal canal.

The ultrasound examination will be performed using a Lumify linear probe (frequency range 4-12 MHz). In the longitudinal projection, the doctor will assess the sites of the spinal cord endings by marking them with a sterile marker - a horizontal line on the patient's back. In the same projection, the doctor will designate a safe and optimal site (the greatest width of the dural sac) for performing a lumbar puncture by marking it with a sterile marker. Additionally, in the longitudinal projection, the researcher will measure the depth from the skin surface to the dura mater. Then, in the transverse projection, the doctor will confirm the absence of the spinal cord at the planned puncture site and the optimal amount of cerebrospinal fluid in the selected space. This information will be passed on to the operator, who will ultimately decide on the location of the lumbar puncture.

In patients in the control group, the lumbar puncture will be performed by palpation, without additional interventions. The position of the patient in both groups will depend on the preferences of the physician performing the puncture. The procedure time will be measured from the moment the needle pierces the skin until the moment of obtaining cerebrospinal fluid or removing the needle if the fluid is not obtained. In the research group, the time of the ultrasound examination will be additionally measured.

Being tested
bedside ultrasound examination of the lumbar spinal canal
Medical subject headings
Meningitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bedside ultrasound examination of the lumbar spinal canalDiagnostic test

    The ultrasound examination will be performed using a Lumify linear probe (frequency range 4-12 MHz). In the longitudinal projection, the doctor will assess the spinal cord endings by marking them with a sterile marker - a horizontal line on the patient's back. In the same projection, the doctor will designate a safe and optimal place (the greatest width of the dural sac) for performing a lumbar puncture by marking it with a sterile marker. Additionally, in the longitudinal projection, the researcher will measure the depth from the skin surface to the dura mater. Then, in the transverse projection, the doctor will confirm the absence of the spinal cord at the planned puncture site and the optimal amount of cerebrospinal fluid in the selected space. This information will be passed on to the operator, who will ultimately decide on the lumbar puncture site.

Study groups in NCT06584864
Study groupRoleWhat they receive
Utrasound groupExperimentalBedside ultrasound examination of the lumbar spinal canal before lumbar puncture
Receives: Diagnostic Test: bedside ultrasound examination of the lumbar spinal canal
Standard groupNo interventionStandard procedure group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Obtaining cerebrospinal fluid after the first attempt at lumbar puncture

    Obtaining cerebrospinal fluid after the first attempt at lumbar puncture (at least 0.5 ml in volume, with a red blood cell count of <10,000/mm3).

    Measured: 1 day

Secondary outcomes (7)
  1. obtaining cerebrospinal fluid - < 10,000/mm3 - at any attempt

    obtaining cerebrospinal fluid (volume min. 0.5 ml, with erythrocyte count < 10,000/mm3) in subsequent puncture attempts

    Measured: 1 day

  2. obtaining cerebrospinal fluid - > 10,000/mm3 - at any attempt

    obtaining bloody cerebrospinal fluid (volume min. 0.5 ml, with erythrocyte count > 10,000/mm3)

    Measured: 1 day

  3. total number of puncture attempts to obtain cerebrospinal fluid

    total number of puncture attempts to obtain cerebrospinal fluid in each patient (next puncture will be understood as another puncture of the skin with a needle)

    Measured: 1 day

  4. unsuccessful puncture - failure to obtain cerebrospinal fluid

    total number of participants with unsuccessful puncture - failure to obtain cerebrospinal fluid

    Measured: 1 day

  5. duration of puncture

    Mean duration of puncture for each patient Measured from the moment of puncturing the skin with the needle to the moment of obtaining cerebrospinal fluid or removal of the needle in the case of unsuccessful puncture.

    Measured in seconds.

    Measured: 1 day

  6. assessment of the impact of ultrasound imaging on the effectiveness of lumbar puncture depending on the experience of the physician performing the lumbar puncture

    Difference in success rate depending on experience - measured by the number of punctures performed so far) puncture: 0-5 low experience, 6-15 medium experience, >15 high experience.

    Measured: 1 day

  7. assessment of the impact of ultrasound imaging on the effectiveness of lumbar puncture depending on the patient's BMI z-score

    Difference in success rate depending onthe patient's BMI z-score

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Mar 2026 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

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
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label, randomized interventional study
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06584864
Sponsor's protocol ID
KB/278/2023
Status last verified
Jul 2025
First submitted
2 Aug 2024
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing bedside ultrasound examination of the lumbar spinal canal in people with Meningitis and Pediatric Disorder, run by Medical University of Warsaw at 1 site in Poland.

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 4 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 30 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 Poland. 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 Agata - Ćwiek, MD (22-317-95-37, agata.cwiek@uckwum.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Obtaining cerebrospinal fluid after the first attempt at lumbar puncture (time frame: 1 day). 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 30 Jul 2025.

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