Traumatic TapLiPSTICkNCT05009173
Lumbar Puncture Stylet Technique in Children
A study testing Lumbar puncture using the stylet-in technique and Lumbar puncture using the stylet-out technique in people with Traumatic Tap, run by St. Justine's Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Traumatic Tap
- What is being tested?
- Lumbar puncture using the stylet-in technique and Lumbar puncture using the stylet-out technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteCanada
- Study dates
- 21 Sep 2020to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Ariane Boutin, MD MSc FRCPC, 514-345-4931, arianeboutin@gmail.com
About this study
Official title: 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.
Read more
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
- Being tested
- Lumbar puncture using the stylet-in technique, Lumbar puncture using the stylet-out technique
- Keywords
- Lumbar puncture, Stylet-in, Stylet-out, Children, Emergency Department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar puncture using the stylet-in techniqueProcedure or surgery
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 techniqueProcedure or surgery
Also called Lumbar puncture using the early stylet removal 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.
| Study group | Role | What they receive |
|---|---|---|
| Stylet-in | Active comparator | Lumbar puncture performed keeping the stylet inside the needle until the practitioner reaches the appropriate location. Receives: Procedure: Lumbar puncture using the stylet-in technique |
| Stylet-out | Active comparator | The practitioner remove the stylet once he/she has passed the skin and moves the needle forward with the stylet. Receives: Procedure: Lumbar puncture using the stylet-out technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour after procedure
Secondary outcomes (7)
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
Measured: 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)
Measured: 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
Measured: immediately after procedure
Number of changes in provider performing the lumbar puncture
The first provider could be a trainee, and then a trained physician
Measured: immediately after procedure
Length of procedure
Measured from the time the needle pierces the skin until first drop of CSF
Measured: 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
Measured: during procedure
Satisfaction with procedure
LP provider satisfaction as measured by a five-point Likert Scale
Measured: immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start21 Sep 2020
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic TapStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 395 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariane Boutin MD, MSc FRCPC, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009173
- Sponsor's protocol ID
- Stylet in:out
- Acronym
- LiPSTICk
- Status last verified
- Oct 2022
- First submitted
- 17 Mar 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LiPSTICk Trial-Lumbar Puncture Stylet Technique in Children; A Randomized-controlled Study
- ClinicalTrials.gov ID
- NCT05009173
- Acronym / sponsor ID
- LiPSTICk / Stylet in:out
- Conditions
- Traumatic Tap
- Keywords
- Lumbar puncture, Stylet-in, Stylet-out, Children, Emergency Department
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 395 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stylet-in | Active comparator | Procedure: Lumbar puncture using the stylet-in techniqueLumbar puncture performed keeping the stylet inside the needle until the practitioner reaches the appropriate location. |
| Stylet-out | Active comparator | Procedure: Lumbar puncture using the stylet-out techniqueThe practitioner remove the stylet once he/she has passed the skin and moves the needle forward with the stylet. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar puncture using the stylet-in techniqueThis 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. | Procedure or surgery | Stylet-in |
| Lumbar puncture using the stylet-out techniqueAlso: Lumbar puncture using the early stylet removal techniqueThis 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. | Procedure or surgery | Stylet-out |
Primary outcome
First-time lumbar puncture success rate
Time frame: 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
7 secondary outcomes
Lumbar puncture success rate despite the number of attempts
Time frame: 1 hour after procedure
Proportion of final traumatic lumbar puncture
Time frame: 1 hour after procedure
Number of lumbar puncture attempts in total
Time frame: immediately after procedure
Number of changes in provider performing the lumbar puncture
Time frame: immediately after procedure
Length of procedure
Time frame: immediately after procedure
Mean difference in Evendol pain scores and NRS-11 scores
Time frame: during procedure
Satisfaction with procedure
Time frame: immediately after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar puncture using the stylet-in technique and Lumbar puncture using the stylet-out technique in people with Traumatic Tap, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariane Boutin, MD MSc FRCPC (514-345-4931, arianeboutin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-time lumbar puncture success rate (time frame: 1 hour after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.