Recruiting

Lumbar Puncture

Sponsor:

St. Justine's Hospital

Code:

NCT05009173

Conditions

Traumatic Tap

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Lumbar puncture using the stylet-in technique

Lumbar puncture using the stylet-out technique

Study Details

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.

Conditions

Traumatic Tap

Study ID

NCT05009173

Start date

Sep 21, 2020

Status verified date

Oct, 2022

Completion date

Dec, 2024

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Enrollment

395 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Stylet-in

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

active comparator: Stylet-out

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

Interventions

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.

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.

Primary outcome measure

  • First-time lumbar puncture success rate [ Time Frame: 1 hour after procedure ]

Central Contacts and Locations

Central contacts

Ariane Boutin, MD MSc FRCPC

514-345-4931arianeboutin@gmail.com

Jocelyn Gravel, MD MSc FRCPC

514-345-4931graveljocelyn@hotmail.com

Locations

CHU Sainte-Justine

Recruiting

Montréal, Quebec, Canada, H3T 1C5

Contacts

Ariane Boutin, MD MSc FRCPC

514-345-4931arianeboutin@gmail.com

More Information

Sponsor

St. Justine's Hospital

Last update posted

Oct 28, 2022

Last verified

Oct, 2022

Keywords

  • Lumbar puncture
  • Stylet-in
  • Stylet-out
  • Children
  • Emergency Department

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2022-10-28.