<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/NCT01735292</url>
  </required_header>
  <id_info>
    <org_study_id>0209-12-HMO</org_study_id>
    <nct_id>NCT01735292</nct_id>
  </id_info>
  <brief_title>Safety of the Automatic Respiration Transfer System- Timer</brief_title>
  <acronym>Timer</acronym>
  <official_title>Safety of the Automatic Respiration Transfer System- Timer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hadassah Medical Organization</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shaare Zedek Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hadassah Medical Organization</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Israel Terminally Ill Law, 2005 allows patients who are terminally ill and ventilated to&#xD;
      have their ventilator placed on a timer which at a specific time in the future stops the&#xD;
      ventilator, maintains the patient on positive pressure (CPAP) and allows the patient not to&#xD;
      be reconnected to the ventilator. We will evaluate the safety of the Automatic Respiration&#xD;
      Transfer-Timer by assessing vital signs, oxygenation and ventilatory pressures and volumes&#xD;
      during the use of the timer with the regular ventilator. In addition, we will evaluate&#xD;
      whether the timer stops the ventilator and switches to CPAP at the designated time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">January 2014</completion_date>
  <primary_completion_date type="Anticipated">January 2014</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety of the Automatic Respiration Transfer System- Timer</measure>
    <time_frame>one year</time_frame>
    <description>Number of Adverse Events</description>
  </primary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Intensive Care Patients on a Ventilator</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Automatic Respiration Transfer System- Timer</intervention_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ventilated patients with informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non- ventilated patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Sprung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hadassah Medical Organization</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Charles Sprung, MD</last_name>
    <phone>97226778060</phone>
    <email>charless@ekmd.huji.ac.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hadassah Medical Organization</name>
      <address>
        <city>Jerusalem</city>
        <zip>93588</zip>
        <country>Israel</country>
      </address>
    </facility>
    <investigator>
      <last_name>Charles Sprung, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>November 23, 2012</last_update_submitted>
  <last_update_submitted_qc>November 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hadassah Medical Organization</investigator_affiliation>
    <investigator_full_name>SPRUNG CHARLES</investigator_full_name>
    <investigator_title>Director, General Intensive Care Unit</investigator_title>
  </responsible_party>
  <keyword>Ventilation, timer</keyword>
  <!-- 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/NCT01735292
org study id: 0209-12-HMO
nct id: NCT01735292
lead sponsor: 
collaborator: 
has dmc: No
The Israel Terminally Ill Law, 2005 allows patients who are terminally ill and ventilated to
      have their ventilator placed on a timer which at a specific time in the future stops the
      ventilator, maintains the patient on positive pressure (CPAP) and allows the patient not to
      be reconnected to the ventilator. We will evaluate the safety of the Automatic Respiration
      Transfer-Timer by assessing vital signs, oxygenation and ventilatory pressures and volumes
      during the use of the timer with the regular ventilator. In addition, we will evaluate
      whether the timer stops the ventilator and switches to CPAP at the designated time.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Safety of the Automatic Respiration Transfer System- Timer
time frame: one year
description: Number of Adverse Events
intervention type: Device
intervention name: Automatic Respiration Transfer System- Timer
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
last name: Charles Sprung, MD
role: Principal Investigator
affiliation: Hadassah Medical Organization
last name: Charles Sprung, MD
phone: 97226778060
email: charless@ekmd.huji.ac.il
facility: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Hadassah Medical Organization
investigator full name: SPRUNG CHARLES
investigator title: Director, General Intensive Care Unit