Ultrasound Guided Diagnostic Lumbar Puncture in Neurology

NCT03815045 | Terminated

• 1 other identifier: D17180
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Puncture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to completion of LP, in minutes

  Immediately following consent, during baseline visit, approximately 1 hour

• Number of attempts to obtain CSF

  Immediately following consent, during baseline visit

• Incidence of traumatic tap

  Time taken to run analysis of CSF RBC count, approximately within 1 day

• Pain after the procedure

  Immediately post-procedure, approximately 5 minutes

• Occurrence of post LP headache

  Phone call within 72 hours of procedure

Study Arms (2)

Landmark-based lumbar puncture

ACTIVE COMPARATOR

Landmark-based LP

Procedure: Landmark-based lumbar puncture

Ultrasound-guided lumbar puncture

ACTIVE COMPARATOR

Ultrasound-guided LP

Procedure: Ultrasound-guided lumbar puncture

Interventions

Landmark-based lumbar puncture PROCEDURE

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.

Landmark-based lumbar puncture

Ultrasound-guided lumbar puncture PROCEDURE

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.

Ultrasound-guided lumbar puncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient scheduled for LP through Neurology's LP clinic
• years of age or older
• Able to understand the description of procedure and provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 24, 2019
• Study Start: July 20, 2017
• Primary Completion: March 10, 2023
• Study Completion: December 31, 2023
• Last Updated: January 31, 2024

Record last verified: 2023-09

Locations

US (1)