Ultrasound Guided Diagnostic Lumbar Puncture in Neurology

Study Overview
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Brief Summary
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Subjects who are having a lumbar puncture as part of their clinical care will be randomized to either a traditional landmark based lumbar puncture or ultrasound guided lumbar puncture. The primary objective of study is to compare the success rate of obtaining CSF using Ultrasound guided technique against the Traditional Landmark based approach. Secondary objectives are to evaluate factors influencing the success or failure, patient tolerance, and a safety assessment.

Detailed Description
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Seventy-two subjects will be randomized into either a traditional landmark-based lumbar puncture or an ultrasound-guided lumbar puncture for obtaining CSF. This study will be conducted in the Neurology clinic. For subjects in the traditional group, the site of needle entry will be determined through palpation of the spine. For subjects in the ultrasound group, site entry will be done using ultrasound guidance. Success and failure of these techniques will be compared along with secondary outcome measures aimed at assessing the safety and efficacy of each of these techniques.

Official Title
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Ultrasound Guided Diagnostic Lumbar Puncture in Neurology

Conditions
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Lumbar Puncture

Intervention / Treatment
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* Procedure: Landmark-based lumbar puncture
* Procedure: Ultrasound-guided lumbar puncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for LP through Neurology's LP clinic 18 years of age or older Able to understand the description of procedure and provide informed consent Exclusion Criteria: Any contraindications to doing a standard lumbar puncture; which typically includes risk of bleeding from effects of anticoagulants or bleeding disorders or an infection at the potential site of entry in the back. This includes subjects with spinal cord stimulators.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Landmark-based lumbar puncture<br>Landmark-based LP | Procedure: Landmark-based lumbar puncture<br>* Traditional landmark based lumbar puncture involves palpating spinous processes on the back and finding the inter-spinous space which is the site of needle entry to gain access to the thecal sac. Finding this space may be difficult by palpation, especially when subjects undergoing the procedure are obese, elderly, have had prior back surgery, or if the patient is positioned incorrectly.<br>|
| Active Comparator: Ultrasound-guided lumbar puncture<br>Ultrasound-guided LP | Procedure: Ultrasound-guided lumbar puncture<br>* Ultrasound guided lumbar puncture is a novel technique being increasingly utilized by emergency physicians, pediatricians and anesthesiologists. In this technique, an ultrasound probe is used to visualize the inter-spinous space. This space can be marked on the skin as the potential point of entry. This could potentially make it easier when patient factors make it difficult to palpate and find the site of entry.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of obtaining CSF within 3 attempts | The success of the procedure is defined as the ability to obtain CSF within 3 attempts via Landmark based LP vs Ultrasound guided LP | During the baseline visit, approximately 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to completion of LP, in minutes | Time taken to complete procedure, either traditional vs. ultrasound LP, to obtain CSF | Immediately following consent, during baseline visit, approximately 1 hour | 
| Number of attempts to obtain CSF | The number of attempts it takes to obtain CSF | Immediately following consent, during baseline visit | 
| Incidence of traumatic tap | defined as CSF RBC count >400/ml | Time taken to run analysis of CSF RBC count, approximately within 1 day | 
| Pain after the procedure | Universal Pain Assessment Tool: Subject-reported pain level as rated on a scale of 0 - 10. Lower score indicates a better outcome. | Immediately post-procedure, approximately 5 minutes | 
| Occurrence of post LP headache | Subject-reported incidence of post LP headache within 72 hours | Phone call within 72 hours of procedure |