Ultrasound-Assisted Lumbar Puncture

Study Overview
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Brief Summary
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Although the lumbar puncture is a common procedure and has been performed without ultrasound for decades, other research studies suggest that there may be some benefits to using ultrasound. This study intends to see whether by using ultrasound there is increased success rate, decreased need for additional procedures, and less discomfort during the procedure.

Official Title
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Ultrasound-localized Landmark Identification in Hospitalized Patients Requiring Lumbar Puncture: Implications for Safety, Quality, and Procedural Success

Conditions
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Spinal Puncture, Diagnostic Imaging

Intervention / Treatment
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* Procedure: Point-of-care ultrasound
* Procedure: Traditional Landmark-based Lumbar Puncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who registered for an emergency or inpatient encounter between 5/22/2017 and 5/08/2018 Males or females 18 years of age or older Patients who have been identified as requiring a lumbar puncture for any therapeutic or diagnostic or therapeutic indication, as decided by the neurology staff physicians, residents, or advanced practice providers. Exclusion Criteria: Patients who are not capable of providing consent for participation in research and do not have an authorized relative or power of attorney to consent in their stead. Patients who require lumbar puncture in an emergency, time dependent fashion and in whom a possible delay could conceivable have a negative clinical impact. Patients with known abnormal lumbar spinal anatomy or prior extensive surgical fusion such that fluoroscopic or CT guidance is determined to be more clinically appropriate by the treating physicians. BMI greater than 60 Absolute contraindication to lumbar puncture such as uncorrected coagulopathy

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be enrolled into the control group (Landmark-based palpation and skin marking) vs the experimental group (ultrasound assisted identification of bony landmarks and skin marking).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Traditional landmark-based lumbar puncture technique by palpation | Procedure: Traditional Landmark-based Lumbar Puncture<br>* Palpation of anatomical landmarks to identify midline and interspinous space<br>|
| Experimental: Experimental (ultrasound)<br>Use of point-of-care ultrasound to identify bony landmarks. | Procedure: Point-of-care ultrasound<br>* A point-of-care ultrasound machine will be utilized to identify and mark midline and the interspinous space based on visualization of spinous processes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Procedural Duration | This is defined by number of minutes from initiating of patient positioning (prior to evaluation of the anatomical landmarks) to first flow of cerebrospinal fluid (CSF). | Approximately 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Procedures Considered to be Failures | As defined by inability to obtain cerebrospinal fluid despite multiple attempts, terminated at the discretion of the procedurist as would otherwise be clinically determined. | Approximately 1 hour | 
| Number of Fluoroscopically Guided or CT Guided Lumbar Punctures | In the event of ultrasound procedural failure by clinician | Approximately 7 days | 
| Total number of unique skin punctures | This will be defined by the needle bevel completely exiting and skin and being re-inserted, during the duration of the procedure, whether the procedure is ultimately successful or not. | Approximately 1 day | 
| Procedurist reported ease of the procedure | Procedurist reported ease of the procedure will be reported by a 10 cm visual analog scale, with 0=easy and 10=very difficult. | Approximately 1 day | 
| Patient reported discomfort | Patient reported discomfort will be reported by a 10 cm visual analog scale, with 0=no discomfort and 10=extreme discomfort. | Approximately 1 day | 
| Number of red blood cells in collected CSF | This will be abstracted manually from the patient's electronic medical record. | Approximately 1 day | 
| Hospital Length of Stay | This will be abstracted manually from the patient's electronic medical record. | Approximately 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Point of Care Ultrasound