xml: <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/NCT06022523</url>
    </required_header>
    <id_info>
      <org_study_id>21-344376</org_study_id>
      <nct_id>NCT06022523</nct_id>
    </id_info>
    <brief_title>Accuracy of Pulse Oximeters With Profound Hypoxia</brief_title>
    <official_title>Accuracy of Pulse Oximeters With Profound Hypoxia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Consolidated Research, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Consolidated Research, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is the acquisition of photoplethysmography signals during&#xD;
        periods of profound hypoxia. The study is designed in accordance with ISO 80601-&#xD;
        2-61,2ed:2017-12 &amp; 2018-02.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 9, 2022</start_date>
    <completion_date type="Anticipated">November 9, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 9, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Saturation level measurement</measure>
      <time_frame>Within 12 months of subject recruitment</time_frame>
      <description>Induction of hypoxia by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide to allow measurement of oxyhemoglobin saturation between 70-100%. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Hypoxemia</condition>
    <arm_group>
      <arm_group_label>Acquisition</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects will undergo profound hypoxia with stable plateaus.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Data acquisition using DT-400 pulse oximetry system</intervention_name>
      <description>Acquisition of photopleth data during profound hypoxia using a Consolidated Research DT-400 pulse oximetry system.</description>
      <arm_group_label>Acquisition</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Pregnancy -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Consolidated Research, Inc.</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44132</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Richard Kaplan, Ph.D.</last_name>
        <phone>216-289-2331</phone>
        <email>kaplan@cri-systems.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>November 30, 2022</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Hypoxia</keyword>
    <keyword>Pulse oximetry</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypoxia</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06022523
  org study id: 21-344376
  nct id: NCT06022523
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  The goal of this clinical trial is the acquisition of photoplethysmography signals during
        periods of profound hypoxia. The study is designed in accordance with ISO 80601-
        2-61,2ed:2017-12 & 2018-02.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Saturation level measurement
  time frame: Within 12 months of subject recruitment
  description: Induction of hypoxia by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide to allow measurement of oxyhemoglobin saturation between 70-100%. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable
  arm group label: Acquisition
  arm group type: Experimental
  description: Subjects will undergo profound hypoxia with stable plateaus.
  intervention type: Diagnostic Test
  intervention name: Data acquisition using DT-400 pulse oximetry system
  description: Acquisition of photopleth data during profound hypoxia using a Consolidated Research DT-400 pulse oximetry system.
  arm group label: Acquisition
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Hypoxia