<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/NCT04453722</url>
  </required_header>
  <id_info>
    <org_study_id>20-505</org_study_id>
    <nct_id>NCT04453722</nct_id>
  </id_info>
  <brief_title>Prevention of Opioid-Induced Hypoxemia</brief_title>
  <official_title>Wearable Device for Prevention of Opioid-Induced Hypoxemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will evaluate the feasibility of a fully randomized validation trial for&#xD;
      the Oxalert EPO. All patients will wear the Oxalert for 24 hours preoperatively in the&#xD;
      monitoring only mode (no alerts), throughout hospitalization up to six days, and for 24&#xD;
      post-discharge hours. Randomization will be to Oxalert in monitor-only mode or to its normal&#xD;
      mode which provides progressive audible and tactile alerts for hypoxemia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Actual">April 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The fraction of time during the initial six post-operative in-hospital days that patients wear the device.</measure>
    <time_frame>initial six post-op in hospital days.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The frequency of hypoxemic episodes detected by the Oxalert EPO that generate an alert in the hospital.</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time-weighted average SpO2 below a threshold of 90%.</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of in-hospital postoperative desaturation events (saturation &lt;90%) lasting at least 2 min.</measure>
    <time_frame>6 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of hypoxemic episodes (saturation &lt;90%) during the initial 24 post-discharge hours lasting at least 2 min.</measure>
    <time_frame>24 hours post discharge</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Non-cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>Oxalert in monitor only mode</arm_group_label>
    <description>Randomization will be to Oxalert in monitor-only mode</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxalert in monitor in normal mode</arm_group_label>
    <description>Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oxalert Monitor</intervention_name>
    <description>The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.</description>
    <arm_group_label>Oxalert in monitor only mode</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oxalert Monitor</intervention_name>
    <description>The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode</description>
    <arm_group_label>Oxalert in monitor in normal mode</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators will enroll patients who are at increased risk for respiratory&#xD;
        insufficiency. Specifically, the investigators will focus on patients scheduled for&#xD;
        laparoscopic or open major abdominal or pelvic surgery whose analgesia is primarily&#xD;
        opioid-based. The investigators will further restrict enrollment to obese patients (body&#xD;
        mass index kg/m2) who are likely to have respiratory compromise. Both men and women will be&#xD;
        recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults having major laparoscopic and open abdominal or pelvic surgeries;&#xD;
&#xD;
          -  Body Mass Index ≥25 kg/m2&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status 1-3;&#xD;
&#xD;
          -  Age 18-85 years old;&#xD;
&#xD;
          -  Able to understand and consent to the trial and fully participate;&#xD;
&#xD;
          -  Anticipated primary opioid analgesia after surgery;&#xD;
&#xD;
          -  Expected duration of hospitalization at least 24 hours after surgery;&#xD;
&#xD;
          -  Consenting at least 24 hours before anticipated surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Epidural analgesia (field and fascial plane blocks permitted);&#xD;
&#xD;
          -  Pre-operative SpO2 &lt;95%;&#xD;
&#xD;
          -  No wrist available for the study;&#xD;
&#xD;
          -  Severe hearing loss;&#xD;
&#xD;
          -  Lack of English language fluency.&#xD;
&#xD;
          -  Serious hearing deficit (unable to understand normal speech in a quite environment)&#xD;
&#xD;
          -  Serious peripheral neuropathy (unable to feel pin prick at wrist).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Sessler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>September 16, 2022</last_update_submitted>
  <last_update_submitted_qc>September 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 2, 2023</submitted>
    <returned>August 24, 2023</returned>
  </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/NCT04453722
org study id: 20-505
nct id: NCT04453722
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
To evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO.
The investigators will evaluate the feasibility of a fully randomized validation trial for
      the Oxalert EPO. All patients will wear the Oxalert for 24 hours preoperatively in the
      monitoring only mode (no alerts), throughout hospitalization up to six days, and for 24
      post-discharge hours. Randomization will be to Oxalert in monitor-only mode or to its normal
      mode which provides progressive audible and tactile alerts for hypoxemia.
observational model: Cohort
time perspective: Other
measure: The fraction of time during the initial six post-operative in-hospital days that patients wear the device.
time frame: initial six post-op in hospital days.
measure: The frequency of hypoxemic episodes detected by the Oxalert EPO that generate an alert in the hospital.
time frame: 24 hours
measure: Time-weighted average SpO2 below a threshold of 90%.
time frame: 24 hours
measure: Duration of in-hospital postoperative desaturation events (saturation <90%) lasting at least 2 min.
time frame: 6 days
measure: Duration of hypoxemic episodes (saturation <90%) during the initial 24 post-discharge hours lasting at least 2 min.
time frame: 24 hours post discharge
arm group label: Oxalert in monitor only mode
description: Randomization will be to Oxalert in monitor-only mode
arm group label: Oxalert in monitor in normal mode
description: Randomization will be to Oxalert in monitor normal mode which provides progressive audible and tactile alerts for hypoxemia.
intervention type: Device
intervention name: Oxalert Monitor
description: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
arm group label: Oxalert in monitor only mode
intervention type: Device
intervention name: Oxalert Monitor
description: The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode
arm group label: Oxalert in monitor in normal mode
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Daniel Sessler, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypoxia
submitted: August 2, 2023
returned: August 24, 2023