Lumbar Puncture Stylet Technique in Children

NCT ID: NCT05009173

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-21
• Study Completion Date: 2024-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Stylet-in

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

Group Type: ACTIVE_COMPARATOR

Lumbar puncture using the stylet-in technique

Intervention Type: PROCEDURE

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.

Stylet-out

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

Group Type: ACTIVE_COMPARATOR

Lumbar puncture using the stylet-out technique

Intervention Type: PROCEDURE

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.

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Lumbar puncture using the early stylet removal technique

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ariane Boutin MD, MSc FRCPC

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ariane Boutin, MD MSc FRCPC

Role: CONTACT

arianeboutin@gmail.com

514-345-4931

Jocelyn Gravel, MD MSc FRCPC

Role: CONTACT

graveljocelyn@hotmail.com

514-345-4931

Facility Contacts

Ariane Boutin, MD MSc FRCPC

Role: primary

arianeboutin@gmail.com

514-345-4931

Other Identifiers

Stylet in:out

Identifier Type: -

Identifier Source: org_study_id