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.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: July 20, 2021
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.
- Procedure: Landmark-based lumbar puncture
- 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.
- Procedure: Ultrasound-guided lumbar puncture
- 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.
Arms, Groups and Cohorts
- Active Comparator: Landmark-based lumbar puncture
- Landmark-based LP
- Active Comparator: Ultrasound-guided lumbar puncture
- Ultrasound-guided LP
Clinical Trial Outcome Measures
- Success rate of obtaining CSF within 3 attempts
- Time Frame: During the baseline visit, approximately 1 hour
- 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 to completion of LP, in minutes
- Time Frame: Immediately following consent, during baseline visit, approximately 1 hour
- Time taken to complete procedure, either traditional vs. ultrasound LP, to obtain CSF
- Number of attempts to obtain CSF
- Time Frame: Immediately following consent, during baseline visit
- The number of attempts it takes to obtain CSF
- Incidence of traumatic tap
- Time Frame: Time taken to run analysis of CSF RBC count, approximately within 1 day
- defined as CSF RBC count >400/ml
- Pain after the procedure
- Time Frame: Immediately post-procedure, approximately 5 minutes
- Universal Pain Assessment Tool: Subject-reported pain level as rated on a scale of 0 – 10. Lower score indicates a better outcome.
- Occurrence of post LP headache
- Time Frame: Phone call within 72 hours of procedure
- Subject-reported incidence of post LP headache within 72 hours
Participating in This Clinical Trial
- 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
- 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Dartmouth-Hitchcock Medical Center
- Provider of Information About this Clinical Study
- Principal Investigator: Vijay Renga, Principal Investigator – Dartmouth-Hitchcock Medical Center
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