Bedside Ultrasound on the Effectiveness of Lumbar Puncture in Children.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorMedical University of Warsaw
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
children <18 years of age
patients who are scheduled to undergo lumbar puncture
consent of legal guardian
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
bedside ultrasound examination of the lumbar spinal canal
Diagnostic testThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Utrasound groupExperimental treatment 1 intervention
Group B: Standard groupNo intervention 0 interventions
Trial outcomes
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).
Time frame
1 daySecondary outcomes
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
Time frame
1 day2
obtaining cerebrospinal fluid - > 10,000/mm3 - at any attempt
obtaining bloody cerebrospinal fluid (volume min. 0.5 ml, with erythrocyte count \> 10,000/mm3)
Time frame
1 day3
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)
Time frame
1 day4
unsuccessful puncture - failure to obtain cerebrospinal fluid
total number of participants with unsuccessful puncture - failure to obtain cerebrospinal fluid
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov