Lumbar Puncture Stylet Technique in Children (LiPSTICk)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Tap
• Intervention / Treatment: Procedure: Lumbar puncture using the stylet-in technique; Procedure: Lumbar puncture using the stylet-out technique

• Study Type: Interventional
• Enrollment (Anticipated): 395
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ariane Boutin, MD MSc FRCPC; Phone Number: 514-345-4931; Email: arianeboutin@gmail.com
• Study Contact Backup: Name: Jocelyn Gravel, MD MSc FRCPC; Phone Number: 514-345-4931; Email: graveljocelyn@hotmail.com

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3T 1C5
      • Recruiting
      • CHU Sainte-Justine
      • Contact: Ariane Boutin, MD MSc FRCPC; Phone Number: 514-345-4931; Email: arianeboutin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stylet-in; Lumbar puncture performed keeping the stylet inside the needle until the practitioner reaches the appropriate location.	Procedure: Lumbar puncture using the stylet-in technique; 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.
Active Comparator: Stylet-out; 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; 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.; Other Names: Lumbar puncture using the early stylet removal technique

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Justine's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2020
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Children; Emergency Department; Lumbar puncture; Stylet-in; Stylet-out
• Other Study ID Numbers: Stylet in:out

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No