<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/NCT03029754</url>
  </required_header>
  <id_info>
    <org_study_id>Bio 16-331</org_study_id>
    <nct_id>NCT03029754</nct_id>
  </id_info>
  <brief_title>Effect of Passive Leg Raise for Pediatric Peripheral IV Placement</brief_title>
  <official_title>Effect of Passive Leg Raise for Pediatric Peripheral IV Placement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Saskatchewan</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>
      The investigators wish to determine whether passive leg raise allows for easier peripheral&#xD;
      vascular access in the pediatric population. The investigators hypothesize that pediatric&#xD;
      anesthesiologists will have higher rates of successful intravenous catheterization in&#xD;
      children where a passive leg raise is employed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 17, 2017</start_date>
  <completion_date type="Actual">December 14, 2017</completion_date>
  <primary_completion_date type="Actual">December 14, 2017</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>Treatment</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in peripheral vein diameter</measure>
    <time_frame>at 5 minutes</time_frame>
    <description>Change between vein diameter at baseline and following group allocation.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Intravenous Access</condition>
  <arm_group>
    <arm_group_label>Passive leg raise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant's legs will be raised with a bolster prior to IV insertion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No leg raise</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will lie flat prior to IV insertion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Passive leg raise</intervention_name>
    <description>A baseline vein diameter will be obtained using ultrasound by the sub-investigator. Then a nurse will raise the child's legs using a bolster while a second measurement of the child's vein diameter is recorded by the sub-investigator. The anesthesiologist will then place the IV and rate the degree of difficulty encountered.</description>
    <arm_group_label>Passive leg raise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pediatric participants undergoing dental procedures under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who already have adequate IV access&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Gamble, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Saskatchewan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal University Hospital</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>January 8, 2019</last_update_submitted>
  <last_update_submitted_qc>January 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
    <investigator_full_name>Jonathan Gamble</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03029754
org study id: Bio 16-331
nct id: NCT03029754
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators wish to determine whether passive leg raise allows for easier peripheral
      vascular access in the pediatric population. The investigators hypothesize that pediatric
      anesthesiologists will have higher rates of successful intravenous catheterization in
      children where a passive leg raise is employed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
measure: Mean change in peripheral vein diameter
time frame: at 5 minutes
description: Change between vein diameter at baseline and following group allocation.
arm group label: Passive leg raise
arm group type: Experimental
description: Participant's legs will be raised with a bolster prior to IV insertion.
arm group label: No leg raise
arm group type: No Intervention
description: Participants will lie flat prior to IV insertion.
intervention type: Procedure
intervention name: Passive leg raise
description: A baseline vein diameter will be obtained using ultrasound by the sub-investigator. Then a nurse will raise the child's legs using a bolster while a second measurement of the child's vein diameter is recorded by the sub-investigator. The anesthesiologist will then place the IV and rate the degree of difficulty encountered.
arm group label: Passive leg raise
criteria: 
gender: All
minimum age: 3 Months
maximum age: 14 Years
healthy volunteers: No
last name: Jonathan Gamble, MD
role: Principal Investigator
affiliation: University of Saskatchewan
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Saskatchewan
investigator full name: Jonathan Gamble
investigator title: M.D.
sharing ipd: No