Ultrasound-Assisted Lumbar Puncture

Mayo Clinic32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Spinal Puncture Diagnostic Imaging

Interventions

Point-of-care ultrasoundPROCEDURE

A point-of-care ultrasound machine will be utilized to identify and mark midline and the interspinous space based on visualization of spinous processes.

Traditional Landmark-based Lumbar PuncturePROCEDURE

Palpation of anatomical landmarks to identify midline and interspinous space

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who registered for an emergency or inpatient encounter between 5/22/2017 and 5/08/2018 2. Males or females 18 years of age or older 3. 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: 1. 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. 2. Patients who require lumbar puncture in an emergency, time dependent fashion and in whom a possible delay could conceivable have a negative clinical impact. 3. 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. 4. BMI greater than 60 5. Absolute contraindication to lumbar puncture such as uncorrected coagulopathy

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: Approximately 1 hour

Secondary Outcomes

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.

Time frame: Approximately 1 hour

Number of Fluoroscopically Guided or CT Guided Lumbar Punctures

In the event of ultrasound procedural failure by clinician

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Approximately 1 day

Number of red blood cells in collected CSF

This will be abstracted manually from the patient's electronic medical record.

Data from ClinicalTrials.gov

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