Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children.

NCT06584864 | Recruiting

• 1 other identifier: KB/278/2023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Meningitis; Pediatric Disorder

Outcome Measures

Primary Outcomes (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).

  1 day

Secondary Outcomes (7)

• obtaining cerebrospinal fluid - < 10,000/mm3 - at any attempt

  1 day

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

  1 day

• total number of puncture attempts to obtain cerebrospinal fluid

  1 day

• unsuccessful puncture - failure to obtain cerebrospinal fluid

  1 day

• duration of puncture

  1 day

Study Arms (2)

Utrasound group

EXPERIMENTAL

Bedside ultrasound examination of the lumbar spinal canal before lumbar puncture

Diagnostic Test: bedside ultrasound examination of the lumbar spinal canal

Standard group

NO INTERVENTION

Standard procedure group

Interventions

bedside ultrasound examination of the lumbar spinal canal DIAGNOSTIC_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.

Utrasound group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medcial Univeristy of Warsaw

Warsaw, 02-091, Poland

RECRUITING

MeSH Terms

Conditions

Meningitis

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Study Officials

• Agata Ćwiek, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agata - Ćwiek, MD

CONTACT

22-317-95-37; agata.cwiek@uckwum.pl

Maciej - Kołodziej, MD

CONTACT

22-317-95-37; maciej.kolodziej@uckwum.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open-label study
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, randomized interventional study

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: September 5, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Locations

PL (1)