Lumbar Puncture Stylet Technique in Children

Study Overview
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Brief Summary
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Lumbar puncture (LP) is a procedure performed frequently among children in the emergency department (ED). Although it has been performed for decades, and for distinct indications, the technique itself can often lead to traumatic results, which can complicate its interpretation and lead to over-treatments and hospitalizations. Several factors have been suggested to improve the success rate of LPs. Among them, the stylet-out (SO), also known as the early stylet removal technique, has been suggested but not properly studied. The aim of this study is to evaluate whether the stylet-out technique can reduce the probability of failure or traumatic lumbar puncture procedures in a pediatric population presenting to the emergency department as compared to the standard stylet-in (SI) approach. To achieve this goal, the investigator will conduct a randomized controlled trial comparing the SO versus SI techniques in a tertiary care, pediatric, university-affiliated emergency. All children younger than 18 years of age requiring a LP as part of their ED workup will be eligible and randomized to either the standard SI or SO group. The primary outcome will be the first-attempt LP success rate as defined by the minimum amount of cerebrospinal fluid (CSF) necessary to perform a leukocyte count and bacterial/viral CSF cultures, according to each laboratory with red blood cell count < 1000/mm3. Secondary outcomes will include the following: overall LP success rate (i.e. despite number of attempts), proportion of traumatic LP, number of LP attempts, number of changes in providers performing the LP, proportion of traumatic LP, total time to procedure, mean difference in pain scores and satisfaction rates in both groups. The hypothesis is that the use of the Stylet Out approach will reduce the number of failed and traumatic LP in the pediatric population presenting to the ED as compared to the standard SI approach.

Official Title
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LiPSTICk Trial-Lumbar Puncture Stylet Technique in Children; A Randomized-controlled Study

Conditions
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Traumatic Tap

Intervention / Treatment
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* Procedure: Lumbar puncture using the stylet-in technique
* Procedure: Lumbar puncture using the stylet-out technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients younger than 18 years of age (no minimal age) All patients who require a diagnostic lumbar puncture as part of their emergency department workup Exclusion Criteria: Patients with lumbar puncture contraindications Parents/patients unable to give consent Patients who have had a traumatic of failed lumbar puncture prior to the emergency department transfer

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stylet-in<br>Lumbar puncture performed keeping the stylet inside the needle until the practitioner reaches the appropriate location. | Procedure: Lumbar puncture using the stylet-in technique<br>* This method consists of inserting the needle with the stylet-in, then only remove the stylet once the desired depth is achieved and CSF flow is expected. If no CSF comes back, the stylet is replaced before continuing to advance the needle until the subarachnoid space is entered. This is the technique generally used in our emergency department and will serve as the control treatment group.<br>|
| Active Comparator: Stylet-out<br>The practitioner remove the stylet once he/she has passed the skin and moves the needle forward with the stylet. | Procedure: Lumbar puncture using the stylet-out technique<br>* This method consists of inserting the needle through the epidermis and the dermis, which is estimated as a 0.5 to 1 cm length in children, then remove the stylet before progressing through the other structures until the subarachnoid space is entered. This approach will be used in the experimental technique group.<br>* Other names: Lumbar puncture using the early stylet removal technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First-time lumbar puncture success rate | Defined as the minimum amount of CSF necessary to perform a leukocyte count and a CSF bacterial/viral culture, according to the hospital laboratory, with a red blood cell count <1,000/mm3 | 1 hour after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar puncture success rate despite the number of attempts | Defined as the minimum amount of CSF necessary to perform a leukocyte count and CSF bacterial/viral culture according to each laboratory with red blood cell count <1,000/mm3 | 1 hour after procedure | 
| Proportion of final traumatic lumbar puncture | Defined as a red blood cell count > 1,000/mm3 not explained by a concomitant meningitis diagnosis (i.e. negative culture) | 1 hour after procedure | 
| Number of lumbar puncture attempts in total | Defined as any time a needle that is completely outside the body penetrates the skin | immediately after procedure | 
| Number of changes in provider performing the lumbar puncture | The first provider could be a trainee, and then a trained physician | immediately after procedure | 
| Length of procedure | Measured from the time the needle pierces the skin until first drop of CSF | immediately after procedure | 
| Mean difference in Evendol pain scores and NRS-11 scores | Evendol pain scores will be applied for all patients and NRS-11 will be applied for children 6 years and older remembering the procedure | during procedure | 
| Satisfaction with procedure | LP provider satisfaction as measured by a five-point Likert Scale | immediately after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency Department, Lumbar puncture, Stylet-in, Stylet-out, Children