Ultrasound-Assisted Lumbar Puncture in Children

Study Overview
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Brief Summary
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The aim of this study is to determine if emergency physician performed ultrasound-assisted lumbar puncture improves first-time success rates in a pediatric population. This will be done by comparison with current landmark-based approach to the procedure.

Official Title
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Emergency Physician Performed Ultrasound-Assisted Lumbar Puncture in a Pediatric Population: A Randomized Controlled Trial

Conditions
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Fever

Intervention / Treatment
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* Radiation: ultrasound-assisted lumbar puncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient less than 19 years of age Requiring a lumbar puncture as part of their work-up, as determined by the treating pediatric emergency physician. Exclusion Criteria: • Patients with known spine or spinal cord abnormalities Patients with ventricular shunts Patients deemed too unstable to have procedure performed Patients at risk for significant bleeding (coagulopathy, thrombocytopenia, etc) Parents unable to give consent or patients unable to assent for an acute reason

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound assisted lumbar puncture<br>The intervention of interest will be the ultrasound-assisted lumbar puncture (UALP). To do this, the treating physician will perform a bedside ultrasound of the spine to identify and mark the level of the conus medullaris and preferred puncture site prior to LP | Radiation: ultrasound-assisted lumbar puncture<br>* The ultrasound probe type will be selected by the treating pediatric emergency physician who has been trained according to standards outlined below. They will first identify the conus medullaris and make a horizontal marking with a sterile pen on the patient's back. Using a transverse view, they will then identify the midline of the patient's spine (using adjacent spinous processes) and will make 2 vertical skin markings on either side of the probe. Next, they will orient the probe in a longitudinal view to identify the desired vertebral interspace and will make 2 horizontal skin markings on either side of the probe at this level. Finally the 4 lines will be joined together at an intersection point, which will be the predetermined site for puncture attempt.<br>|
| No Intervention: Standard lumbar puncture<br>The control group will have a standard landmark-based lumbar puncture | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First-tie success | First-time lumbar puncture success rate is defined by the presence of at least 0.5 mL of cerebrospinal fluid with red blood cell count < 1,000/mm3. | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total lumbar puncture success rate | defined by the presence of at least 0.5 mL of cerebrospinal fluid with red blood cell count < 1,000/mm3 in any number of attempt | 15 minutes | 
| Change in performer | If the lumbar puncture was attempted by a second person following the first attempts | 15 minutes | 
| Time of procedure | Time to perform the lumbar puncture | 30 minutes | 
| Complication | Occurence of any complication | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar puncture, Point of care ultrasound, children