<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/NCT01693705</url>
  </required_header>
  <id_info>
    <org_study_id>0053-12-HYMC</org_study_id>
    <nct_id>NCT01693705</nct_id>
  </id_info>
  <brief_title>Outcome Evaluation of Patients After Percutaneous Tracheostomy Due to Respiratory Failure in an Intensive Care Unit</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the morbidity and mortality of patients who have undergone percutaneous&#xD;
      tracheostomy due to respiratory failure in the critical care unit and after intensive care in&#xD;
      the internal medicine department, including follow-up of quality of life of these patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">April 2013</completion_date>
  <primary_completion_date type="Anticipated">April 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with tracheostomy due to respiratory failure who died</measure>
    <time_frame>Six months</time_frame>
    <description>Retrospective review of charts showing increase in morbidity in patients with respiratory failure with tracheostomy taking place 2 weeks after admission to critical care</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">55</enrollment>
  <condition>Respiratory Insufficiency</condition>
  <arm_group>
    <arm_group_label>Tracheostomy Patients</arm_group_label>
    <description>Critical care patients with respiratory failure who were mechanically ventilated and who underwent tracheostomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Tracheostomy Patients</arm_group_label>
    <description>Critical care patients with respiratory failure who were mechanically ventilated but did not undergo tracheostomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tracheostomy</intervention_name>
    <arm_group_label>Tracheostomy Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with respiratory failure who were mechanically ventilated in the critical care&#xD;
        unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mechanically ventilated critical care patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All others&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Boris Isakovich, MD</last_name>
    <phone>972-4-6304460</phone>
    <email>borisi@hy.health.gov.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <investigator>
      <last_name>Boris Isakovich, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 24, 2012</last_update_submitted>
  <last_update_submitted_qc>September 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tracheostomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</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/NCT01693705
org study id: 0053-12-HYMC
nct id: NCT01693705
lead sponsor: 
has dmc: No
To determine the morbidity and mortality of patients who have undergone percutaneous
      tracheostomy due to respiratory failure in the critical care unit and after intensive care in
      the internal medicine department, including follow-up of quality of life of these patients.
observational model: Case-Control
time perspective: Retrospective
measure: Number of patients with tracheostomy due to respiratory failure who died
time frame: Six months
description: Retrospective review of charts showing increase in morbidity in patients with respiratory failure with tracheostomy taking place 2 weeks after admission to critical care
arm group label: Tracheostomy Patients
description: Critical care patients with respiratory failure who were mechanically ventilated and who underwent tracheostomy
arm group label: Non-Tracheostomy Patients
description: Critical care patients with respiratory failure who were mechanically ventilated but did not undergo tracheostomy
intervention type: Procedure
intervention name: Tracheostomy
arm group label: Tracheostomy Patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Boris Isakovich, MD
phone: 972-4-6304460
email: borisi@hy.health.gov.il
facility: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Respiratory Insufficiency