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.
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.
Poland1 site, 1 recruiting
- 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
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.
- Conditions
- Meningitis, Pediatric Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Utrasound group | Experimental | Bedside ultrasound examination of the lumbar spinal canal before lumbar puncture Receives: Diagnostic Test: bedside ultrasound examination of the lumbar spinal canal |
| Standard group | No intervention | Standard procedure group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
unsuccessful puncture - failure to obtain cerebrospinal fluid
total number of participants with unsuccessful puncture - failure to obtain cerebrospinal fluid
Measured: 1 day
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
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
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.
- First posted5 Sep 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningitisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, randomized interventional study
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agata Ćwiek, MD, Principal investigator, Medical University of Warsaw
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children - Open-label Randomized Trial
- ClinicalTrials.gov ID
- NCT06584864
- Acronym / sponsor ID
- KB/278/2023
- Conditions
- Meningitis, Pediatric Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 5 Sep 2024 (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 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomized interventional study
| Arm | Type | Receives |
|---|---|---|
| Utrasound group | Experimental | Diagnostic Test: bedside ultrasound examination of the lumbar spinal canalBedside ultrasound examination of the lumbar spinal canal before lumbar puncture |
| Standard group | No intervention | –Standard procedure group |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- children <18 years of age
- patients who are scheduled to undergo lumbar puncture
- consent of legal guardian
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| bedside ultrasound examination of the lumbar spinal canalThe 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. | Diagnostic test | Utrasound group |
Primary outcome
Obtaining cerebrospinal fluid after the first attempt at lumbar puncture
Time frame: 1 day
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).
7 secondary outcomes
obtaining cerebrospinal fluid - < 10,000/mm3 - at any attempt
Time frame: 1 day
obtaining cerebrospinal fluid - > 10,000/mm3 - at any attempt
Time frame: 1 day
total number of puncture attempts to obtain cerebrospinal fluid
Time frame: 1 day
unsuccessful puncture - failure to obtain cerebrospinal fluid
Time frame: 1 day
duration of puncture
Time frame: 1 day
assessment of the impact of ultrasound imaging on the effectiveness of lumbar puncture depending on the experience of the physician performing the lumbar puncture
Time frame: 1 day
assessment of the impact of ultrasound imaging on the effectiveness of lumbar puncture depending on the patient's BMI z-score
Time frame: 1 day
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 30 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Agata Ćwiek, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
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; AzTrials last refreshed its copy on 8 Nov 2026.