<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/NCT03789396</url>
  </required_header>
  <id_info>
    <org_study_id>18-1528</org_study_id>
    <nct_id>NCT03789396</nct_id>
  </id_info>
  <brief_title>Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients</brief_title>
  <official_title>Pilot Study of Targeted Normoxia in Critically Ill Trauma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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>
      The objective of this study is to conduct an observational pre/post study to evaluate the&#xD;
      clinical impact oxygen guideline implementation on oxygen utilization and oxygenation in&#xD;
      critically ill trauma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Supplemental oxygen is fundamental in caring for critically ill trauma. While the avoidance&#xD;
      of hypoxia is vital, the current clinical practice of excessive oxygenation settings is&#xD;
      common, and unnecessary, and may even be harmful.&#xD;
&#xD;
      An expert panel convened to define optimal oxygenation targets in critically ill trauma&#xD;
      patients. The strong consensus was to target normoxia at an oxygen saturation (SpO2) range of&#xD;
      90-96% and arterial oxygen (PaO2) range of 60-100 mmHg. Accordingly, a pilot trial&#xD;
      implementation of this consensus will occur for the care of trauma patients.&#xD;
&#xD;
      Specific Aim:&#xD;
&#xD;
      This is an observational pre/post study to evaluate the impact of targeted normoxia&#xD;
      implementation in optimizing oxygen delivery and oxygenation in critically ill trauma&#xD;
      patients.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
      That the clinical efforts to improve adherence to oxygen guidelines will:&#xD;
&#xD;
        1. improve the proportion of time spent with target normoxia thresholds (oxygen saturation&#xD;
           SpO2 90-96%) by&#xD;
&#xD;
        2. reducing utilization of unnecessary supplementation oxygen&#xD;
&#xD;
        3. without a substantive increase in hypoxic episodes or an adverse impact on clinical&#xD;
           outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Actual">September 19, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>28 Days</target_duration>
  <primary_outcome>
    <measure>Oxygen by volume</measure>
    <time_frame>From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days</time_frame>
    <description>Volume of oxygen administered during hospital stay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Episodes of Hypoxia (SpO2&lt; 88%)</measure>
    <time_frame>From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days</time_frame>
    <description>SpO2 saturations below 88%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Episodes of Hyperoxia (SpO2 &gt;96%)</measure>
    <time_frame>From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days</time_frame>
    <description>SpO2 saturations above 96%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator Free Day</measure>
    <time_frame>From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days</time_frame>
    <description>Ventilator Free Days = Days off ventilator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to room air</measure>
    <time_frame>From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days</time_frame>
    <description>Duration of supplemental oxygen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measured by daily Sequential Organ Failure Assessment (SOFA)</measure>
    <time_frame>First 7 days of hospitalization</time_frame>
    <description>Acute organ injury as measured by SOFA score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>From time of emergency department arrival until the date of ICU discharge or death, assessed up to 180 days</time_frame>
    <description>Number of days spent in the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days</time_frame>
    <description>Number of days spent in the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital discharge disposition</measure>
    <time_frame>Date of hospital discharge, assessed up to 180 days</time_frame>
    <description>Discharged to facility or home = measuring illness at discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Mortality</measure>
    <time_frame>From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">618</enrollment>
  <condition>Trauma</condition>
  <condition>Critical Illness</condition>
  <condition>Oxygen Toxicity</condition>
  <arm_group>
    <arm_group_label>Pre-implementation</arm_group_label>
    <description>The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-implementation</arm_group_label>
    <description>The intervention group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Targeted Normoxia (oxygen saturation 90-96%)</intervention_name>
    <description>The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation</description>
    <arm_group_label>Post-implementation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care Oxygenation</intervention_name>
    <description>The control (pre-implementation) group will be trauma patients admitted to the ICU during the 12 months prior to the targeted normoxia implementation</description>
    <arm_group_label>Pre-implementation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill trauma patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute Injury/Trauma&#xD;
&#xD;
          -  Arrival to Emergency Department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years of age&#xD;
&#xD;
          -  Known prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>109 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adit Ginde, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>June 22, 2021</last_update_submitted>
  <last_update_submitted_qc>June 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oxygenation</keyword>
  <keyword>Hypoxia</keyword>
  <keyword>Normoxia</keyword>
  <keyword>Hyperoxia</keyword>
  <keyword>Trauma</keyword>
  <keyword>Critical Illness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 3, 2021</submitted>
    <returned>December 23, 2021</returned>
    <submitted>February 1, 2022</submitted>
    <returned>April 5, 2022</returned>
    <submitted>April 15, 2022</submitted>
    <returned>January 10, 2023</returned>
    <submitted>June 20, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03789396
org study id: 18-1528
nct id: NCT03789396
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to conduct an observational pre/post study to evaluate the
      clinical impact oxygen guideline implementation on oxygen utilization and oxygenation in
      critically ill trauma patients.
Supplemental oxygen is fundamental in caring for critically ill trauma. While the avoidance
      of hypoxia is vital, the current clinical practice of excessive oxygenation settings is
      common, and unnecessary, and may even be harmful.

      An expert panel convened to define optimal oxygenation targets in critically ill trauma
      patients. The strong consensus was to target normoxia at an oxygen saturation (SpO2) range of
      90-96% and arterial oxygen (PaO2) range of 60-100 mmHg. Accordingly, a pilot trial
      implementation of this consensus will occur for the care of trauma patients.

      Specific Aim:

      This is an observational pre/post study to evaluate the impact of targeted normoxia
      implementation in optimizing oxygen delivery and oxygenation in critically ill trauma
      patients.

      Hypotheses:

      That the clinical efforts to improve adherence to oxygen guidelines will:

        1. improve the proportion of time spent with target normoxia thresholds (oxygen saturation
           SpO2 90-96%) by

        2. reducing utilization of unnecessary supplementation oxygen

        3. without a substantive increase in hypoxic episodes or an adverse impact on clinical
           outcomes.
observational model: Case-Control
time perspective: Prospective
measure: Oxygen by volume
time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
description: Volume of oxygen administered during hospital stay
measure: Episodes of Hypoxia (SpO2< 88%)
time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
description: SpO2 saturations below 88%
measure: Episodes of Hyperoxia (SpO2 >96%)
time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
description: SpO2 saturations above 96%
measure: Ventilator Free Day
time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
description: Ventilator Free Days = Days off ventilator
measure: Time to room air
time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 28 days
description: Duration of supplemental oxygen
measure: Measured by daily Sequential Organ Failure Assessment (SOFA)
time frame: First 7 days of hospitalization
description: Acute organ injury as measured by SOFA score
measure: ICU length of stay
time frame: From time of emergency department arrival until the date of ICU discharge or death, assessed up to 180 days
description: Number of days spent in the ICU
measure: Hospital length of stay
time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days
description: Number of days spent in the hospital
measure: Hospital discharge disposition
time frame: Date of hospital discharge, assessed up to 180 days
description: Discharged to facility or home = measuring illness at discharge
measure: Hospital Mortality
time frame: From time of emergency department arrival until the date of hospital discharge or death, assessed up to 180 days
arm group label: Pre-implementation
description: The control groups will be trauma patients admitted to the ICU 12 months prior to targeted normoxia
arm group label: Post-implementation
description: The intervention group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation.
intervention type: Other
intervention name: Targeted Normoxia (oxygen saturation 90-96%)
description: The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation
arm group label: Post-implementation
intervention type: Other
intervention name: Usual Care Oxygenation
description: The control (pre-implementation) group will be trauma patients admitted to the ICU during the 12 months prior to the targeted normoxia implementation
arm group label: Pre-implementation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 109 Years
healthy volunteers: No
last name: Adit Ginde, MD, MPH
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Critical Illness
mesh term: Wounds and Injuries
sharing ipd: No
submitted: November 3, 2021
returned: December 23, 2021
submitted: February 1, 2022
returned: April 5, 2022
submitted: April 15, 2022
returned: January 10, 2023
submitted: June 20, 2023