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Ultrasound Guided Diagnostic Lumbar Puncture in Neurology

Primary Purpose

Lumbar Puncture

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Landmark-based lumbar puncture
Ultrasound-guided lumbar puncture
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lumbar Puncture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Landmark-based lumbar puncture

Ultrasound-guided lumbar puncture

Arm Description

Landmark-based LP

Ultrasound-guided LP

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to completion of LP, in minutes
Time taken to complete procedure, either traditional vs. ultrasound LP, to obtain CSF
Number of attempts to obtain CSF
The number of attempts it takes to obtain CSF
Incidence of traumatic tap
defined as CSF RBC count >400/ml
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.
Occurrence of post LP headache
Subject-reported incidence of post LP headache within 72 hours

Full Information

First Posted
January 22, 2019
Last Updated
September 19, 2023
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03815045
Brief Title
Ultrasound Guided Diagnostic Lumbar Puncture in Neurology
Official Title
Ultrasound Guided Diagnostic Lumbar Puncture in Neurology
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
March 10, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Puncture

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Landmark-based lumbar puncture
Arm Type
Active Comparator
Arm Description
Landmark-based LP
Arm Title
Ultrasound-guided lumbar puncture
Arm Type
Active Comparator
Arm Description
Ultrasound-guided LP
Intervention Type
Procedure
Intervention Name(s)
Landmark-based lumbar puncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided lumbar puncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Success rate of obtaining CSF within 3 attempts
Description
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
Secondary Outcome Measure Information:
Title
Time to completion of LP, in minutes
Description
Time taken to complete procedure, either traditional vs. ultrasound LP, to obtain CSF
Time Frame
Immediately following consent, during baseline visit, approximately 1 hour
Title
Number of attempts to obtain CSF
Description
The number of attempts it takes to obtain CSF
Time Frame
Immediately following consent, during baseline visit
Title
Incidence of traumatic tap
Description
defined as CSF RBC count >400/ml
Time Frame
Time taken to run analysis of CSF RBC count, approximately within 1 day
Title
Pain after the procedure
Description
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
Title
Occurrence of post LP headache
Description
Subject-reported incidence of post LP headache within 72 hours
Time Frame
Phone call within 72 hours of procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

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Ultrasound Guided Diagnostic Lumbar Puncture in Neurology

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