<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03815045</url>
  </required_header>
  <id_info>
    <org_study_id>D17180</org_study_id>
    <nct_id>NCT03815045</nct_id>
  </id_info>
  <brief_title>Ultrasound Guided Diagnostic Lumbar Puncture in Neurology</brief_title>
  <official_title>Ultrasound Guided Diagnostic Lumbar Puncture in Neurology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects who are having a lumbar puncture as part of their clinical care will be randomized&#xD;
      to either a traditional landmark based lumbar puncture or ultrasound guided lumbar puncture.&#xD;
      The primary objective of study is to compare the success rate of obtaining CSF using&#xD;
      Ultrasound guided technique against the Traditional Landmark based approach. Secondary&#xD;
      objectives are to evaluate factors influencing the success or failure, patient tolerance, and&#xD;
      a safety assessment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Seventy-two subjects will be randomized into either a traditional landmark-based lumbar&#xD;
      puncture or an ultrasound-guided lumbar puncture for obtaining CSF. This study will be&#xD;
      conducted in the Neurology clinic. For subjects in the traditional group, the site of needle&#xD;
      entry will be determined through palpation of the spine. For subjects in the ultrasound&#xD;
      group, site entry will be done using ultrasound guidance. Success and failure of these&#xD;
      techniques will be compared along with secondary outcome measures aimed at assessing the&#xD;
      safety and efficacy of each of these techniques.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 26, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate of obtaining CSF within 3 attempts</measure>
    <time_frame>During the baseline visit, approximately 1 hour</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to completion of LP, in minutes</measure>
    <time_frame>Immediately following consent, during baseline visit, approximately 1 hour</time_frame>
    <description>Time taken to complete procedure, either traditional vs. ultrasound LP, to obtain CSF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attempts to obtain CSF</measure>
    <time_frame>Immediately following consent, during baseline visit</time_frame>
    <description>The number of attempts it takes to obtain CSF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of traumatic tap</measure>
    <time_frame>Time taken to run analysis of CSF RBC count, approximately within 1 day</time_frame>
    <description>defined as CSF RBC count &gt;400/ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain after the procedure</measure>
    <time_frame>Immediately post-procedure, approximately 5 minutes</time_frame>
    <description>Universal Pain Assessment Tool: Subject-reported pain level as rated on a scale of 0 - 10. Lower score indicates a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of post LP headache</measure>
    <time_frame>Phone call within 72 hours of procedure</time_frame>
    <description>Subject-reported incidence of post LP headache within 72 hours</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Lumbar Puncture</condition>
  <arm_group>
    <arm_group_label>Landmark-based lumbar puncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Landmark-based LP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrasound-guided lumbar puncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrasound-guided LP</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Landmark-based lumbar puncture</intervention_name>
    <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.</description>
    <arm_group_label>Landmark-based lumbar puncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-guided lumbar puncture</intervention_name>
    <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.</description>
    <arm_group_label>Ultrasound-guided lumbar puncture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient scheduled for LP through Neurology's LP clinic&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Able to understand the description of procedure and provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any contraindications to doing a standard lumbar puncture; which typically includes&#xD;
             risk of bleeding from effects of anticoagulants or bleeding disorders or an infection&#xD;
             at the potential site of entry in the back. This includes subjects with spinal cord&#xD;
             stimulators.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Vijay Renga</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03815045
org study id: D17180
nct id: NCT03815045
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Success rate of obtaining CSF within 3 attempts
time frame: During the baseline visit, approximately 1 hour
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
measure: Time to completion of LP, in minutes
time frame: Immediately following consent, during baseline visit, approximately 1 hour
description: Time taken to complete procedure, either traditional vs. ultrasound LP, to obtain CSF
measure: Number of attempts to obtain CSF
time frame: Immediately following consent, during baseline visit
description: The number of attempts it takes to obtain CSF
measure: Incidence of traumatic tap
time frame: Time taken to run analysis of CSF RBC count, approximately within 1 day
description: defined as CSF RBC count >400/ml
measure: Pain after the procedure
time frame: Immediately post-procedure, approximately 5 minutes
description: Universal Pain Assessment Tool: Subject-reported pain level as rated on a scale of 0 - 10. Lower score indicates a better outcome.
measure: Occurrence of post LP headache
time frame: Phone call within 72 hours of procedure
description: Subject-reported incidence of post LP headache within 72 hours
arm group label: Landmark-based lumbar puncture
arm group type: Active Comparator
description: Landmark-based LP
arm group label: Ultrasound-guided lumbar puncture
arm group type: Active Comparator
description: Ultrasound-guided LP
intervention type: Procedure
intervention name: Landmark-based lumbar puncture
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.
arm group label: Landmark-based lumbar puncture
intervention type: Procedure
intervention name: Ultrasound-guided lumbar puncture
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.
arm group label: Ultrasound-guided lumbar puncture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Vijay Renga
investigator title: Principal Investigator
mesh term: Wounds and Injuries