Lumbar Puncture Stylet Technique in Children

Not Applicable

Recruiting

• Conditions: Traumatic Tap
• Interventions: Procedure: Lumbar puncture using the stylet-in technique; Procedure: Lumbar puncture using the stylet-out technique

• Registration Number: NCT05009173
• Lead Sponsor: St. Justine's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-21
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-17
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 395

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Stylet-in	Lumbar puncture using the stylet-in technique	Lumbar puncture performed keeping the stylet inside the needle until the practitioner reaches the appropriate location.
Stylet-out	Lumbar puncture using the stylet-out technique	The practitioner remove the stylet once he/she has passed the skin and moves the needle forward with the stylet.

Primary Outcome Measures

Name	Time	Method
First-time lumbar puncture success rate	1 hour after procedure	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montréal, Quebec, Canada