Lumbar Puncture Stylet Technique in Children (LiPSTICk)

St. Justine's Hospital

Status: Enrolling

Conditions: Traumatic Tap

Treatments: Procedure: Lumbar puncture using the stylet-in technique; Procedure: Lumbar puncture using the stylet-out technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05009173

Stylet in:out

Details and patient eligibility

About

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.

Enrollment: 395 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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395 participants in 2 patient groups

Stylet-in

Active Comparator group

Description:

Lumbar puncture performed keeping the stylet inside the needle until the practitioner reaches the appropriate location.

Treatment:

Procedure: Lumbar puncture using the stylet-in technique

Stylet-out

Active Comparator group

Description:

The practitioner remove the stylet once he/she has passed the skin and moves the needle forward with the stylet.

Treatment:

Procedure: Lumbar puncture using the stylet-out technique