Traumatic Tap
Conditions
Keywords
Lumbar puncture, Stylet-in, Stylet-out, Children, Emergency Department
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.
Interventions
PROCEDURELumbar 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.
PROCEDURELumbar 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.
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| Number of changes in provider performing the lumbar puncture | immediately after procedure | The first provider could be a trainee, and then a trained physician |
| 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 |
| 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 |
| Length of procedure | immediately after procedure | Measured from the time the needle pierces the skin until first drop of CSF |
Countries
Canada
Contacts
Primary ContactAriane Boutin, MD MSc FRCPC
Backup ContactJocelyn Gravel, MD MSc FRCPC
Outcome results
None listed