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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
38
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.
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.
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
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
Time frame: During the baseline visit, approximately 1 hour
Time to completion of LP, in minutes
Time taken to complete procedure, either traditional vs. ultrasound LP, to obtain CSF
Time frame: Immediately following consent, during baseline visit, approximately 1 hour
Number of attempts to obtain CSF
The number of attempts it takes to obtain CSF
Time frame: Immediately following consent, during baseline visit
Incidence of traumatic tap
defined as CSF RBC count \>400/ml
Time frame: 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.
Time frame: Immediately post-procedure, approximately 5 minutes
Occurrence of post LP headache
Subject-reported incidence of post LP headache within 72 hours
Time frame: Phone call within 72 hours of procedure
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