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Stylet-In vs. Stylet-Out Lumbar Puncture for Traumatic Tap (LiPSTICk Trial)

N/A

Recruiting

Research Sponsored by St. Justine's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients who require a diagnostic lumbar puncture as part of their emergency department workup

All patients younger than 18 years of age (no minimal age)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hour after procedure

Awards & highlights

LiPSTICk Trial Summary

This trial will compare the success rates of two ways to do a lumbar puncture (a medical procedure where a needle is inserted into the lower back to get cerebrospinal fluid) on children in the emergency department - the standard way with a stylet in, or the new way with the stylet out.

Who is the study for?

This trial is for children under 18 who need a diagnostic lumbar puncture in the emergency department. It's not for those with conditions that make lumbar punctures unsafe, or if consent can't be given. Kids who've already had a failed or traumatic lumbar puncture before coming to the ED are also excluded.Check my eligibility

What is being tested?

The study compares two ways of doing a lumbar puncture: leaving the stylet (a small needle) in or taking it out early during the procedure. The goal is to see which method has higher success on the first try without causing trauma, measured by getting enough fluid for tests with minimal blood contamination.See study design

What are the potential side effects?

While specific side effects aren't listed, typical risks of lumbar punctures include headache, back pain, bleeding at the site where the needle was inserted, and very rarely infection.

LiPSTICk Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need a spinal tap as part of my emergency care.

Select...

I am younger than 18 years old.

LiPSTICk Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately after procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

First-time lumbar puncture success rate

Secondary outcome measures

Length of procedure

Lumbar puncture success rate despite the number of attempts

Mean difference in Evendol pain scores and NRS-11 scores

+4 more

LiPSTICk Trial Design

2Treatment groups

Active Control

Group I: Stylet-inActive Control1 Intervention

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

Group II: Stylet-outActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor

196 Previous Clinical Trials

78,634 Total Patients Enrolled

Media Library

Lumbar puncture using the stylet-in technique Clinical Trial Eligibility Overview. Trial Name: NCT05009173 — N/A

Traumatic Tap Research Study Groups: Stylet-in, Stylet-out

Traumatic Tap Clinical Trial 2023: Lumbar puncture using the stylet-in technique Highlights & Side Effects. Trial Name: NCT05009173 — N/A

Lumbar puncture using the stylet-in technique 2023 Treatment Timeline for Medical Study. Trial Name: NCT05009173 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are presently being enrolled in this experiment?

"Affirmative. According to information published on clinicaltrials.gov, recruitment for this trial is still ongoing since it first opened its doors on September 21st 2020 and was last edited at the end of October 2022. 395 participants are needed for one site in particular."

Answered by AI

Is enrollment currently open for this research project?

"Affirmative, the information available on clinicaltrials.gov points to this trial's ongoing recruitment of participants. Initially posted on September 21st 2020 and most recently edited October 26th 2022, the study is looking for 395 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lumbar Puncture Stylet Technique in Children

Ariane Boutin MD, MSc FRCPC 2020. "Lumbar Puncture Stylet Technique in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05009173.