<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/NCT02973841</url>
  </required_header>
  <id_info>
    <org_study_id>Sono-ease</org_study_id>
    <nct_id>NCT02973841</nct_id>
  </id_info>
  <brief_title>Sono-ease Device for Internal Jaguar Vein Cannulation</brief_title>
  <acronym>Sono-ease</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A novel device attached to ultrasound probe designed to increase success rate and safety of&#xD;
      internal jugular vein cannulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>complications rate</measure>
    <time_frame>24 hours</time_frame>
    <description>hematoma-arterial puncture-pneumothorax</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Internal Jugular Vein Cannulation</condition>
  <arm_group>
    <arm_group_label>Sono-ease group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>insertion IJV catheter using sono-ease device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sono-ease device</intervention_name>
    <description>insertion of US guided IJV using sono-ease device</description>
    <arm_group_label>Sono-ease group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients indicated for IJV catheterization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neck deformities-coagulopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>AlRefaey Kandeel</investigator_full_name>
    <investigator_title>lecturer of anesthesia</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02973841
org study id: Sono-ease
nct id: NCT02973841
lead sponsor: 
has dmc: Yes
A novel device attached to ultrasound probe designed to increase success rate and safety of
      internal jugular vein cannulation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: complications rate
time frame: 24 hours
description: hematoma-arterial puncture-pneumothorax
arm group label: Sono-ease group
arm group type: Experimental
description: insertion IJV catheter using sono-ease device
intervention type: Device
intervention name: Sono-ease device
description: insertion of US guided IJV using sono-ease device
arm group label: Sono-ease group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: AlRefaey Kandeel
investigator title: lecturer of anesthesia
sharing ipd: Yes