Using ultrasound to improve lumbar puncture success in children
Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children - Open-label Randomized Trial
NA · Medical University of Warsaw · NCT06584864
This study is testing whether using ultrasound can help doctors successfully perform lumbar punctures in children under 18 years old.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Medical University of Warsaw (other) |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT06584864 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate how ultrasound examination of the lumbar spinal canal affects the success rate of lumbar punctures in children under 18 years old. It is an open-label, randomized interventional study where participants will be divided into two groups: one receiving standard care and the other undergoing ultrasound-guided procedures. The ultrasound is intended to help visualize anatomical structures, potentially reducing the risk of traumatic or unsuccessful punctures. The study will also assess the experience level of the physicians performing the procedures to understand its impact on outcomes.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years old who are scheduled to undergo a lumbar puncture.
Not a fit: Patients with skin infections at the puncture site or developmental defects of the spine may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to higher success rates and fewer complications during lumbar punctures in pediatric patients.
How similar studies have performed: While the use of ultrasound in lumbar punctures is promising, this specific approach in pediatric patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * children \<18 years of age * patients who are scheduled to undergo lumbar puncture * consent of legal guardian Exclusion Criteria: * 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
Where this trial is running
Warsaw
- Medcial Univeristy of Warsaw — Warsaw, Poland (RECRUITING)
Study contacts
- Principal investigator: Agata Ćwiek, MD — Medical University of Warsaw
- Study coordinator: Agata - Ćwiek, MD
- Email: agata.cwiek@uckwum.pl
- Phone: 22-317-95-37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Meningitis, Pediatric Disorder