Clinical trial NCT05009173: Lumbar Puncture Stylet Technique in Children
Official title: LiPSTICk Trial-Lumbar Puncture Stylet Technique in Children; A Randomized-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Tap
Keywords: Lumbar puncture
Stylet-in
Stylet-out
Children
Emergency Department
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 395
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: First-time lumbar puncture success rate
timeFrame: 1 hour after procedure
Secondary outcomes:
measure: Lumbar puncture success rate despite the number of attempts
timeFrame: 1 hour after procedure
measure: Proportion of final traumatic lumbar puncture
timeFrame: 1 hour after procedure
measure: Number of lumbar puncture attempts in total
timeFrame: immediately after procedure
measure: Number of changes in provider performing the lumbar puncture
timeFrame: immediately after procedure
measure: Length of procedure
timeFrame: immediately after procedure
measure: Mean difference in Evendol pain scores and NRS-11 scores
timeFrame: during procedure
measure: Satisfaction with procedure
timeFrame: immediately after procedure
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHU Sainte-Justine
state: Quebec
Study officials:
References: