<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/NCT04481581</url>
  </required_header>
  <id_info>
    <org_study_id>2014H0236</org_study_id>
    <secondary_id>5KL2TR002734-03</secondary_id>
    <nct_id>NCT04481581</nct_id>
  </id_info>
  <brief_title>Titration of Oxygen Levels During Mechanical Ventilation With Electronic Alerts</brief_title>
  <acronym>TOOLs</acronym>
  <official_title>Titration of Inspired Oxygen During Mechanical Ventilation Using a Bedside Decision Support Tool</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Fractional oxygen during mechanical ventilation, is a life sustaining therapy in the&#xD;
      intensive care unit , used for about a million patients annually. Oxygen therapy needs to be&#xD;
      tightly balanced as both hypoxia and hyperoxia are harmful. Establishing precision in&#xD;
      oxygenation has significant implications for improving patient outcomes, resource utilization&#xD;
      and reducing iatrogenic harm to a vulnerable population. The investigators propose an&#xD;
      approach using a oxygen titration protocol consisting of electronic health records based&#xD;
      alerts to guide oxygen adjustment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a prospective randomized, clinical trial in the Medical&#xD;
      Intensive Care Unit at Ohio State University Medical Center. In the intervention arm,&#xD;
      respiratory therapists' will conduct oxygen titration with the help of a novel, high&#xD;
      fidelity, electronic health records based, protocol consisting of electronic alerts and&#xD;
      decision support tool. Oxygen titration in the control arm will be done without alerts and&#xD;
      will be per &quot;current standard of care&quot;.&#xD;
&#xD;
      Participants for this study will be identified and recruited from patients admitted to the&#xD;
      Ohio State University, Wexner Medical Center and James Cancer Hospital, Medical Intensive&#xD;
      Care Unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 5, 2021</start_date>
  <completion_date type="Anticipated">September 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2024</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>
    <intervention_model_description>This will be a parallel design, unblinded, randomized (1:1) trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>In this study providers cannot be masked, outcome assessors and investigators will be blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Hyperoxemia</measure>
    <time_frame>Duration of Mechanical Ventilation, an average of 10-14 days</time_frame>
    <description>The degree of excess exposure will be recorded as percent FiO2 &gt;0.4 when saturation continued to remain above 94%. Primary outcome will be determined by the proportion of time the patient will be &quot;exposed to excessive supplied oxygen&quot; divided by the total time under mechanical ventilation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ventilator Free days</measure>
    <time_frame>28 days</time_frame>
    <description>The number of days between successful weaning from mechanical ventilation and day 28 after study enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>days of ICU stay within hospitalization, average of 20-25 days</time_frame>
    <description>Duration of stay in the intensive care unit after patient enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of stay in the hospital after patient enrollment</measure>
    <time_frame>Current Hospital Stay, upto 30 days</time_frame>
    <description>Duration of stay in the hospital after patient enrollment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Mechanical Ventilation</condition>
  <arm_group>
    <arm_group_label>Intervention arm- Oxygen titration with electronic alerts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oxygen titration will be done based on electronic alerts and decisions support tool by Respiratory Therapists, if FiO2=&gt; 0.4 and SpO2 =&gt;94% for more than 45 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm- Oxygen titration by one time physician orders</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Oxygen titration will be done ventilator management guidelines for the medical intensive care unit. Titration is done by one-time orders.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electronic Alerts</intervention_name>
    <description>When FiO2 remains =&gt;0.4 and SpO2 =&gt;94% for more than 45 minutes, an electronic health record based alert will be sent to respiratory therapists to titrate oxygen per decision support tool.</description>
    <arm_group_label>Intervention arm- Oxygen titration with electronic alerts</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Critically ill subjects who require mechanical ventilation for at least 24 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects without research authorization,&#xD;
&#xD;
          -  Pregnancy,&#xD;
&#xD;
          -  Pneumothorax,&#xD;
&#xD;
          -  Carbon monoxide poisoning,&#xD;
&#xD;
          -  Hyperbaric oxygen therapy&#xD;
&#xD;
          -  Acute ST elevation Myocardial Infarction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sonal R Pannu, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michelle Bright</last_name>
    <phone>614-292-3496</phone>
    <email>michelle.bright@osumc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sonal Pannu</last_name>
      <phone>507-226-1636</phone>
      <email>sonal.pannu@osumc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>August 30, 2022</last_update_submitted>
  <last_update_submitted_qc>August 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Sonal Pannu</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT04481581
org study id: 2014H0236
secondary id: 5KL2TR002734-03
nct id: NCT04481581
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Fractional oxygen during mechanical ventilation, is a life sustaining therapy in the
      intensive care unit , used for about a million patients annually. Oxygen therapy needs to be
      tightly balanced as both hypoxia and hyperoxia are harmful. Establishing precision in
      oxygenation has significant implications for improving patient outcomes, resource utilization
      and reducing iatrogenic harm to a vulnerable population. The investigators propose an
      approach using a oxygen titration protocol consisting of electronic health records based
      alerts to guide oxygen adjustment.
The investigators will conduct a prospective randomized, clinical trial in the Medical
      Intensive Care Unit at Ohio State University Medical Center. In the intervention arm,
      respiratory therapists' will conduct oxygen titration with the help of a novel, high
      fidelity, electronic health records based, protocol consisting of electronic alerts and
      decision support tool. Oxygen titration in the control arm will be done without alerts and
      will be per "current standard of care".

      Participants for this study will be identified and recruited from patients admitted to the
      Ohio State University, Wexner Medical Center and James Cancer Hospital, Medical Intensive
      Care Unit.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This will be a parallel design, unblinded, randomized (1:1) trial
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: In this study providers cannot be masked, outcome assessors and investigators will be blinded
measure: Duration of Hyperoxemia
time frame: Duration of Mechanical Ventilation, an average of 10-14 days
description: The degree of excess exposure will be recorded as percent FiO2 >0.4 when saturation continued to remain above 94%. Primary outcome will be determined by the proportion of time the patient will be "exposed to excessive supplied oxygen" divided by the total time under mechanical ventilation.
measure: Ventilator Free days
time frame: 28 days
description: The number of days between successful weaning from mechanical ventilation and day 28 after study enrollment.
measure: ICU length of stay
time frame: days of ICU stay within hospitalization, average of 20-25 days
description: Duration of stay in the intensive care unit after patient enrollment
measure: Duration of stay in the hospital after patient enrollment
time frame: Current Hospital Stay, upto 30 days
description: Duration of stay in the hospital after patient enrollment
arm group label: Intervention arm- Oxygen titration with electronic alerts
arm group type: Experimental
description: Oxygen titration will be done based on electronic alerts and decisions support tool by Respiratory Therapists, if FiO2=> 0.4 and SpO2 =>94% for more than 45 minutes
arm group label: Control Arm- Oxygen titration by one time physician orders
arm group type: No Intervention
description: Oxygen titration will be done ventilator management guidelines for the medical intensive care unit. Titration is done by one-time orders.
intervention type: Other
intervention name: Electronic Alerts
description: When FiO2 remains =>0.4 and SpO2 =>94% for more than 45 minutes, an electronic health record based alert will be sent to respiratory therapists to titrate oxygen per decision support tool.
arm group label: Intervention arm- Oxygen titration with electronic alerts
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Sonal R Pannu, M.D.
role: Principal Investigator
affiliation: Ohio State University
last name: Michelle Bright
phone: 614-292-3496
email: michelle.bright@osumc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Sonal Pannu
investigator title: Assistant Professor
sharing ipd: No