<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/NCT02999932</url>
  </required_header>
  <id_info>
    <org_study_id>WuhanUHICU201701</org_study_id>
    <nct_id>NCT02999932</nct_id>
  </id_info>
  <brief_title>Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy</brief_title>
  <acronym>POSDOT</acronym>
  <official_title>Effect of Low vs High Peripheral Oxygen Saturation (SpO2) Directed Oxygen Therapy on Mortality Among Critically Ill Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan Union Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wu Jieping Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wuhan Union Hospital, China</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>
      Investigators hypothesized that a relative low SpO2 directed oxygen therapy would reduced the&#xD;
      mortality in patients staying longer than 72 hours in ICUs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In fear of harmful effect of hypoxia, oxygen therapy is commonly used, especially in&#xD;
      critically ill patients in intensive care units (ICUs). However, hyperoxia can be harmful&#xD;
      too. Examples are myocardial infarction (MI) patients and patients resuscitated to return of&#xD;
      spontaneous circulation after cardiac arrest. In Air Versus Oxygen in Myocardial Infarction&#xD;
      (AVOID) trial, Meyhoff and colleagues proved hyperoxia caused more cardiac injury in patients&#xD;
      with ST-elevation MI but without hypoxia. Kilgannon and colleagues found that arterial&#xD;
      hyperoxia following resuscitation from cardiac arrest were associated with increased&#xD;
      in-hospital mortality, and a pulse oxygen saturation (SpO2) of 94-98% was recommended.&#xD;
&#xD;
      Recently, Panwar and colleagues found that compared to liberal oxygen strategy (SpO2 ≥96%),&#xD;
      conservative oxygen strategy (SpO2 of 88%-92%) was feasible in patients receiving invasive&#xD;
      mechanical ventilation. Girardis and colleagues found control oxygen therapy (targeting SpO2&#xD;
      of 94%-98% or PaO2 of 70-100mmHg) resulted lower ICU mortality than conventional oxygen&#xD;
      therapy (SpO2 ≥97%) in the randomized clinical trial called Oxygen-ICU. However, the&#xD;
      Oxygen-ICU trial was single-centered, early-terminated with only 480 patients included and&#xD;
      led to an unplanned interim analysis. In this larger multicenter trial, investigators&#xD;
      hypothesized that a relative low SpO2 directed oxygen therapy was safe and would reduced the&#xD;
      28-day mortality in patients staying longer than 72 hours in ICUs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow inclusion&#xD;
  </why_stopped>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">May 29, 2022</completion_date>
  <primary_completion_date type="Actual">May 1, 2022</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 (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>28-day mortality</measure>
    <time_frame>28 days</time_frame>
    <description>Death within 28 days after inclusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ventilator-free time</measure>
    <time_frame>14 days</time_frame>
    <description>Hours free from ventilator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RRT-free time</measure>
    <time_frame>14 days</time_frame>
    <description>Hours free from renal replacment therapy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1706</enrollment>
  <condition>Critical Illness</condition>
  <arm_group>
    <arm_group_label>Low SpO2 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SpO2 90-95%, with FiO2 as low as possible.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High SpO2 group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SpO2 96-100%, with FiO2 no lower than 30%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SpO2 directed oxygen therapy</intervention_name>
    <description>Oxygen therapy was administered to achieve targeted SpO2.</description>
    <arm_group_label>High SpO2 group</arm_group_label>
    <arm_group_label>Low SpO2 group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aged 18 years or older and admitted into ICU, with expected stay in ICU more than 72&#xD;
             hours or longer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under 18 years old, expected stay in ICU less than 72 hours, unconsented inclusion,&#xD;
             ICU readmission, patients with acute exacerbation of chronic obstruction disease,&#xD;
             patients with severe acute respiratory distress syndrome (defined as PaO2/FiO2 ≤&#xD;
             100mmHg and PEEP ≥10cmH2O), decision to withhold life-sustaining treatment, physician&#xD;
             forgetting to screen during 12 hours after admission, pregnancy, patients with acute&#xD;
             myocardial infarction, paraquat poisoning and patients on extracorporeal membrane&#xD;
             oxygenation (ECMO) or planned to be on ECMO.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shiying Yuan, MD</last_name>
    <role>Study Director</role>
    <affiliation>Wuhan Union Hospital, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of critical care medicine，Luoyang Central Hospital Affiliated to ZhengZhou University</name>
      <address>
        <city>Luoyang</city>
        <state>Henan</state>
        <zip>471000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of critical care medicine，Xinyang Central Hospital</name>
      <address>
        <city>Xinyang</city>
        <state>Henan</state>
        <zip>464000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of critical care medicine, Henan Provincial People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of critical care medicine, The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of critical care medicine，Zhengzhou Central Hospital Affiliated to Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450007</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of critical care medicine, Renmin Hospital of Shiyan City</name>
      <address>
        <city>Shiyan</city>
        <state>Hubei</state>
        <zip>442000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of critical care medicine, Taihe Hospital</name>
      <address>
        <city>Shiyan</city>
        <state>Hubei</state>
        <zip>442000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of critical care medicine, The Central Hospital of Wuhan</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of critical care medicine，Renmin Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intensive Care Unit, Hubei Cancer Hospital</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430079</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of critical care medicine, Xiangyang No.1 People's Hospital, Affiliated Hospital of Hubei University of Medicine</name>
      <address>
        <city>Xiangyang</city>
        <state>Hubei</state>
        <zip>441000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of critical care medicine, XiangYang Central Hospital, Affiliated Hospital of Hubei University of Arts and Science</name>
      <address>
        <city>Xiangyang</city>
        <state>Hubei</state>
        <zip>441021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <removed_countries>
    <country>Austria</country>
  </removed_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>July 8, 2023</last_update_submitted>
  <last_update_submitted_qc>July 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wuhan Union Hospital, China</investigator_affiliation>
    <investigator_full_name>Xiaobo Yang, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02999932
org study id: WuhanUHICU201701
nct id: NCT02999932
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Investigators hypothesized that a relative low SpO2 directed oxygen therapy would reduced the
      mortality in patients staying longer than 72 hours in ICUs.
In fear of harmful effect of hypoxia, oxygen therapy is commonly used, especially in
      critically ill patients in intensive care units (ICUs). However, hyperoxia can be harmful
      too. Examples are myocardial infarction (MI) patients and patients resuscitated to return of
      spontaneous circulation after cardiac arrest. In Air Versus Oxygen in Myocardial Infarction
      (AVOID) trial, Meyhoff and colleagues proved hyperoxia caused more cardiac injury in patients
      with ST-elevation MI but without hypoxia. Kilgannon and colleagues found that arterial
      hyperoxia following resuscitation from cardiac arrest were associated with increased
      in-hospital mortality, and a pulse oxygen saturation (SpO2) of 94-98% was recommended.

      Recently, Panwar and colleagues found that compared to liberal oxygen strategy (SpO2 ≥96%),
      conservative oxygen strategy (SpO2 of 88%-92%) was feasible in patients receiving invasive
      mechanical ventilation. Girardis and colleagues found control oxygen therapy (targeting SpO2
      of 94%-98% or PaO2 of 70-100mmHg) resulted lower ICU mortality than conventional oxygen
      therapy (SpO2 ≥97%) in the randomized clinical trial called Oxygen-ICU. However, the
      Oxygen-ICU trial was single-centered, early-terminated with only 480 patients included and
      led to an unplanned interim analysis. In this larger multicenter trial, investigators
      hypothesized that a relative low SpO2 directed oxygen therapy was safe and would reduced the
      28-day mortality in patients staying longer than 72 hours in ICUs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: 28-day mortality
time frame: 28 days
description: Death within 28 days after inclusion
measure: ventilator-free time
time frame: 14 days
description: Hours free from ventilator
measure: RRT-free time
time frame: 14 days
description: Hours free from renal replacment therapy
arm group label: Low SpO2 group
arm group type: Experimental
description: SpO2 90-95%, with FiO2 as low as possible.
arm group label: High SpO2 group
arm group type: Active Comparator
description: SpO2 96-100%, with FiO2 no lower than 30%.
intervention type: Other
intervention name: SpO2 directed oxygen therapy
description: Oxygen therapy was administered to achieve targeted SpO2.
arm group label: High SpO2 group
arm group label: Low SpO2 group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shiying Yuan, MD
role: Study Director
affiliation: Wuhan Union Hospital, China
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Wuhan Union Hospital, China
investigator full name: Xiaobo Yang, MD
investigator title: MD
mesh term: Critical Illness
sharing ipd: Undecided