<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/NCT02193763</url>
  </required_header>
  <id_info>
    <org_study_id>AHC 4746</org_study_id>
    <nct_id>NCT02193763</nct_id>
  </id_info>
  <brief_title>Bedside Ultrasound Assisted Pediatric Lumbar Puncture</brief_title>
  <official_title>Bedside Ultrasound Assisted Pediatric Lumbar Puncture--A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advocate Health Care</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Advocate Health Care</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, randomized study evaluating the efficacy of bedside ultrasound&#xD;
      assisted lumbar puncture in pediatric patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark&#xD;
      approach in neonates and young infants requiring lumbar puncture&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    PI has relocated to another institution, no other site PI to take over&#xD;
  </why_stopped>
  <start_date>August 2009</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Traumatic lumbar puncture</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>RBC&gt;10,000/ mm3 on spinal fluid analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Unsuccessful lumbar puncture</measure>
    <time_frame>average of &lt;1hour</time_frame>
    <description>failure to yield enough fluid for cerebrospinal fluid cell count as indicated by operator report on data collection sheet</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>average of &lt;7days</time_frame>
    <description>as reported in the subjects' medical record</description>
  </secondary_outcome>
  <other_outcome>
    <measure>clinical outcome/ hospital course of the patient</measure>
    <time_frame>30days</time_frame>
    <description>whether there was any adverse effect/ complication due to lumbar puncture based on review of medical record</description>
  </other_outcome>
  <other_outcome>
    <measure>number of lumbar puncture attempts</measure>
    <time_frame>average of &lt;1hour</time_frame>
    <description>as recorded on the data collection form</description>
  </other_outcome>
  <other_outcome>
    <measure>time to completion of lumbar puncture</measure>
    <time_frame>average of &lt;1hour</time_frame>
    <description>as reported in the data collection form (measured in seconds)</description>
  </other_outcome>
  <other_outcome>
    <measure>perception of the clinician on the usefulness of bedside ultrasound if used</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>as rated on a 1-5 Likert scale by the operator on the data collection form</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Infant/ Neonate Lumbar Puncture</condition>
  <arm_group>
    <arm_group_label>90 days and under--Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neonates aged 90 days and under randomized to ultrasound assisted lumbar puncture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>90 days and under--control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Over 90 days--Interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neonates aged over 90 days randomized to ultrasound assisted lumbar puncture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Over 90 days--Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound assisted lumbar puncture</intervention_name>
    <description>An investigator will perform beside ultrasound on the spinal area using a bedside ultrasound device. Attempts will be made to visualize the spinous processes and vertebral bodies in the general lumbarsacral area, as well as the presence of CSF in the thecal space below the conus medullaris, and identify the optimal location to perform the LP. This will be marked with a skin marker (If no CSF or abnormal anatomy is visualized, the LP will be advised to be postponed or cancelled). The treating physician will then proceed with the LP guided by the skin markings.</description>
    <arm_group_label>90 days and under--Interventional</arm_group_label>
    <arm_group_label>Over 90 days--Interventional</arm_group_label>
    <other_name>Sonosite M-Turbo ultrasound device (Bothell, WA) with a L25 linear transducer</other_name>
    <other_name>or</other_name>
    <other_name>Zonare Z.One device(Mountain View, CA) with a L10-5 linear array transducer,</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient 0-12 months old requiring a lumbar puncture in the pediatric emergency&#xD;
             department or inpatient pediatric floor is eligible to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous back surgeries&#xD;
&#xD;
          -  parent/ guardian inability to understand informed consent&#xD;
&#xD;
          -  parent/guardian refusal of informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel Lam, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Advocate Health Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Advocate Christ Medical Center</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 10, 2019</last_update_submitted>
  <last_update_submitted_qc>July 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Advocate Health Care</investigator_affiliation>
    <investigator_full_name>May Alrahi</investigator_full_name>
    <investigator_title>Clinicaltrials.gov administrator</investigator_title>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>lumbar puncture</keyword>
  <keyword>ultrasonography</keyword>
  <keyword>efficacy</keyword>
  <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/NCT02193763
org study id: AHC 4746
nct id: NCT02193763
lead sponsor: 
has dmc: No
This is a prospective, randomized study evaluating the efficacy of bedside ultrasound
      assisted lumbar puncture in pediatric patients
Comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark
      approach in neonates and young infants requiring lumbar puncture
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Traumatic lumbar puncture
time frame: up to 24 hours
description: RBC>10,000/ mm3 on spinal fluid analysis
measure: Unsuccessful lumbar puncture
time frame: average of <1hour
description: failure to yield enough fluid for cerebrospinal fluid cell count as indicated by operator report on data collection sheet
measure: Hospital length of stay
time frame: average of <7days
description: as reported in the subjects' medical record
measure: clinical outcome/ hospital course of the patient
time frame: 30days
description: whether there was any adverse effect/ complication due to lumbar puncture based on review of medical record
measure: number of lumbar puncture attempts
time frame: average of <1hour
description: as recorded on the data collection form
measure: time to completion of lumbar puncture
time frame: average of <1hour
description: as reported in the data collection form (measured in seconds)
measure: perception of the clinician on the usefulness of bedside ultrasound if used
time frame: up to 24 hours
description: as rated on a 1-5 Likert scale by the operator on the data collection form
arm group label: 90 days and under--Interventional
arm group type: Experimental
description: Neonates aged 90 days and under randomized to ultrasound assisted lumbar puncture
arm group label: 90 days and under--control
arm group type: No Intervention
description: Neonates aged 90 days and under randomized to lumbar puncture using the anatomical landmark approach
arm group label: Over 90 days--Interventional
arm group type: Experimental
description: Neonates aged over 90 days randomized to ultrasound assisted lumbar puncture
arm group label: Over 90 days--Control
arm group type: No Intervention
description: Neonates aged over 90 days randomized to lumbar puncture using the anatomical landmark approach
intervention type: Procedure
intervention name: Ultrasound assisted lumbar puncture
description: An investigator will perform beside ultrasound on the spinal area using a bedside ultrasound device. Attempts will be made to visualize the spinous processes and vertebral bodies in the general lumbarsacral area, as well as the presence of CSF in the thecal space below the conus medullaris, and identify the optimal location to perform the LP. This will be marked with a skin marker (If no CSF or abnormal anatomy is visualized, the LP will be advised to be postponed or cancelled). The treating physician will then proceed with the LP guided by the skin markings.
arm group label: 90 days and under--Interventional
arm group label: Over 90 days--Interventional
other name: Sonosite M-Turbo ultrasound device (Bothell, WA) with a L25 linear transducer
other name: or
other name: Zonare Z.One device(Mountain View, CA) with a L10-5 linear array transducer,
criteria: 
gender: All
minimum age: N/A
maximum age: 12 Months
healthy volunteers: No
last name: Samuel Lam, MD
role: Principal Investigator
affiliation: Advocate Health Care
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Advocate Health Care
investigator full name: May Alrahi
investigator title: Clinicaltrials.gov administrator
mesh term: Wounds and Injuries