<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/NCT01684124</url>
  </required_header>
  <id_info>
    <org_study_id>AICU2012-008</org_study_id>
    <nct_id>NCT01684124</nct_id>
  </id_info>
  <brief_title>An Assessment of the Feasibility and Safety of Conservative Oxygen Therapy in Critically Ill Patients</brief_title>
  <official_title>A Before-and-after Assessment of Conservative Oxygen Therapy vs. Standard Care in Critically Ill Mechanically Ventilated Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Austin Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Austin Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that it is feasible and safe to deliver a conservative approach&#xD;
      to oxygen therapy in mechanically ventilated critically ill patients (a tiem frame of, on&#xD;
      average,10 days).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Identify patients likely to require ventilation until the day after tomorrow (a time&#xD;
           frame of 36 hours of average)&#xD;
&#xD;
        2. Deliver a conservative oxygen therapy protocol while in ICU (a time frame on average of&#xD;
           10 days)&#xD;
&#xD;
        3. Target an oxygen saturation between 90 and 92%&#xD;
&#xD;
        4. Adjust FiO2 to achieve target SaO2 at all times&#xD;
&#xD;
        5. Assess percentage of time patient is within target&#xD;
&#xD;
        6. Assess for safety of this approach&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in PaO2/FiO2 ratio from baseline to worst value</measure>
    <time_frame>10 days</time_frame>
    <description>Pao2/FiO2 ratio will be measured regularly and compared during standard care and the intervention period (a time frame of, on average, 10 days)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lactate</measure>
    <time_frame>10 days</time_frame>
    <description>blood lactate will be measured regularly and assessed during standard care and the intervention period</description>
  </secondary_outcome>
  <other_outcome>
    <measure>arrhythmias</measure>
    <time_frame>10 days</time_frame>
    <description>patients will have continuous ECG monitoring and arrhythmias will be recorded in the two groups</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>standard care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>normal treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conservative O2 therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>a value of 90-92% O2 saturation will be targeted</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conservative O2 therapy</intervention_name>
    <description>target lower O2 saturation</description>
    <arm_group_label>conservative O2 therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard care</intervention_name>
    <arm_group_label>standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mechanical ventilation&#xD;
&#xD;
          -  expected to be ventilated until the day after tomorrow (a tiem frame of, on average 48&#xD;
             hours)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  expected to be off mechanical ventilation today or tomorrow&#xD;
&#xD;
          -  carbon monoxide poisoning&#xD;
&#xD;
          -  necrotizing fasciitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Austin Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3079</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>July 9, 2013</last_update_submitted>
  <last_update_submitted_qc>July 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Austin Health</investigator_affiliation>
    <investigator_full_name>Rinaldo Bellomo</investigator_full_name>
    <investigator_title>Director of ICU Research</investigator_title>
  </responsible_party>
  <keyword>oxygen</keyword>
  <keyword>critical illness</keyword>
  <keyword>mechanical ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT01684124
org study id: AICU2012-008
nct id: NCT01684124
lead sponsor: 
has dmc: No
The investigators hypothesize that it is feasible and safe to deliver a conservative approach
      to oxygen therapy in mechanically ventilated critically ill patients (a tiem frame of, on
      average,10 days).
1. Identify patients likely to require ventilation until the day after tomorrow (a time
           frame of 36 hours of average)

        2. Deliver a conservative oxygen therapy protocol while in ICU (a time frame on average of
           10 days)

        3. Target an oxygen saturation between 90 and 92%

        4. Adjust FiO2 to achieve target SaO2 at all times

        5. Assess percentage of time patient is within target

        6. Assess for safety of this approach
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference in PaO2/FiO2 ratio from baseline to worst value
time frame: 10 days
description: Pao2/FiO2 ratio will be measured regularly and compared during standard care and the intervention period (a time frame of, on average, 10 days)
measure: Lactate
time frame: 10 days
description: blood lactate will be measured regularly and assessed during standard care and the intervention period
measure: arrhythmias
time frame: 10 days
description: patients will have continuous ECG monitoring and arrhythmias will be recorded in the two groups
arm group label: standard care
arm group type: Placebo Comparator
description: normal treatment
arm group label: conservative O2 therapy
arm group type: Active Comparator
description: a value of 90-92% O2 saturation will be targeted
intervention type: Other
intervention name: conservative O2 therapy
description: target lower O2 saturation
arm group label: conservative O2 therapy
intervention type: Other
intervention name: standard care
arm group label: standard care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: Austin Health
investigator full name: Rinaldo Bellomo
investigator title: Director of ICU Research
mesh term: Critical Illness