Ultrasound Guided Diagnostic Lumbar Puncture in Neurology

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 Overview

• Status: Terminated
• Conditions: Lumbar Puncture
• Intervention / Treatment: Procedure: Landmark-based lumbar puncture; Procedure: Ultrasound-guided lumbar puncture

Detailed Description

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
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Landmark-based lumbar puncture; Landmark-based LP	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.
Active Comparator: Ultrasound-guided lumbar puncture; Ultrasound-guided LP	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2017
• Primary Completion (Actual): March 10, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: D17180

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No