<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/NCT02216344</url>
  </required_header>
  <id_info>
    <org_study_id>COVMOPR0440</org_study_id>
    <nct_id>NCT02216344</nct_id>
  </id_info>
  <brief_title>Controlled Acute Hypoxia Study - Abbreviated Sensor Line</brief_title>
  <official_title>Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples Using the Abbreviated Sensor Line in Healthy Subjects With the USB Pulse Oximetry Monitor Interface Cable</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic - MITG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to validate the proposed claims for the OxiCable&#xD;
      device, for pulse rate and saturation accuracy in a diverse subject population over a&#xD;
      specified saturation range.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The general procedure of invasive controlled hypoxia clinical studies is to directly compare&#xD;
      test pulse oximeter measurements to saturation measurements made by a multi-wavelength&#xD;
      CO-oximeter taken from arterial blood samples from healthy human subjects. Following arterial&#xD;
      cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject&#xD;
      breathes while simultaneous measurements are recorded from the test pulse oximeters and&#xD;
      arterial blood samples at targeted levels of saturation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Pulse oximetry measurements of saturation from the test device will be compared to CO-Oximetry measurements of arterial oxygen saturation to demonstrate that the test sensor meets the oxygen saturation accuracy specifications for SpO2.</measure>
    <time_frame>up to 6 months</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">13</enrollment>
  <condition>Healthy</condition>
  <condition>Hypoxia</condition>
  <arm_group>
    <arm_group_label>Pulse Oximeter (the device)</arm_group_label>
    <description>The pulse oximetry devices were placed on subjects per the protocol. The subjects underwent gradual hypoxia and the output of the devices under test was compared to the SaO2 value as measured by a CO-Oximeter (the reference value), as outlined by ISO 80601, to ensure that the devices meet the specified performance claims.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Up to 20 subjects recruited from the Clinical Laboratory subject data base.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female of any race&#xD;
&#xD;
          -  18-50 years old, inclusive&#xD;
&#xD;
          -  Females: negative urine pregnancy test on the day of study participation (prior to&#xD;
             exposure to hypoxia)&#xD;
&#xD;
          -  Completed within the last year: physical exam by a licensed physician, physician&#xD;
             assistant (PA), or advanced practice nurse; including a 12 lead ECG, a medical&#xD;
             history, and blood test (complete blood count and sickle cell trait/disease screening)&#xD;
&#xD;
          -  Meets specific demographic requirements for the monitoring device under study&#xD;
&#xD;
          -  Willing and able to provide written informed consent&#xD;
&#xD;
          -  Able to participate for the duration of the evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years or over 50 years of age&#xD;
&#xD;
          -  Pregnant and/or lactating women&#xD;
&#xD;
          -  Hypertension: on three consecutive readings, systolic pressure greater than 145 mm Hg&#xD;
             or diastolic pressure greater than 90 mm Hg&#xD;
&#xD;
          -  Premature ventricular contractions (PVCs) that are symptomatic or occur at a rate of&#xD;
             more than four per minute&#xD;
&#xD;
          -  History of seizures (except childhood febrile seizures) or epilepsy&#xD;
&#xD;
          -  History of unexplained syncope&#xD;
&#xD;
          -  Daily or more frequent use of anxiolytic drugs (benzodiazepines) for treatment of&#xD;
             anxiety disorder&#xD;
&#xD;
          -  Recent history of frequent migraine headaches: average of two or more per month over&#xD;
             the last year&#xD;
&#xD;
          -  Compromised circulation, injury, or physical malformation of fingers, toes, hands,&#xD;
             ears or forehead/skull or other sensor sites which would limit the ability to test&#xD;
             site needed for the study. (Note: Certain malformations may still allow subjects to&#xD;
             participate if the condition is noted and would not affect the particular sites&#xD;
             utilized.)&#xD;
&#xD;
          -  History of acute altitude sickness at or below moderate elevation (up to 5,000-10,000&#xD;
             feet) defined as three or more of the following symptoms: moderate to severe headache,&#xD;
             general malaise, dizziness/lightheadedness, nausea/vomiting, fatigue/weakness,&#xD;
             shortness of breath, nosebleed, persistent rapid pulse, or peripheral edema&#xD;
&#xD;
          -  History of significant respiratory disease such as severe asthma or emphysema&#xD;
&#xD;
          -  Sickle cell disease or trait&#xD;
&#xD;
          -  Clinically significant abnormal finding on medical history, physical examination,&#xD;
             clinical laboratory test or ECG. Clinical significance will be assessed by the&#xD;
             principal investigator or study physician as designated.&#xD;
&#xD;
          -  History of stroke, transient ischemic attack or carotid artery disease&#xD;
&#xD;
          -  History of myocardial ischemia, angina, myocardial infarction, congestive heart&#xD;
             failure or cardiomyopathy&#xD;
&#xD;
          -  History of chronic renal impairment&#xD;
&#xD;
          -  Severe contact allergies to standard adhesives, latex or other materials found in&#xD;
             pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other&#xD;
             medical sensors&#xD;
&#xD;
          -  Unwillingness or inability to remove colored nail polish from test digit(s)&#xD;
&#xD;
          -  Unwillingness or inability to give informed consent&#xD;
&#xD;
          -  Prior or known allergies to: lidocaine (or similar pharmacological agents, e.g.,&#xD;
             Novocain) or heparin&#xD;
&#xD;
          -  Recent arterial cannulation (i.e., less than 30 days prior to study date)&#xD;
&#xD;
          -  Six or more arterial cannulations of each (right &amp; left) radial artery&#xD;
&#xD;
          -  History of clinically significant complications from previous arterial cannulation&#xD;
&#xD;
          -  Current use of blood thinners: prescription or daily aspirin use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric T Heyer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medtronic - MITG</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boulder Clinical Laboratory</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>September 28, 2016</last_update_submitted>
  <last_update_submitted_qc>September 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patient safety monitors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <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/NCT02216344
org study id: COVMOPR0440
nct id: NCT02216344
lead sponsor: 
has dmc: No
The primary objective of the study is to validate the proposed claims for the OxiCable
      device, for pulse rate and saturation accuracy in a diverse subject population over a
      specified saturation range.
The general procedure of invasive controlled hypoxia clinical studies is to directly compare
      test pulse oximeter measurements to saturation measurements made by a multi-wavelength
      CO-oximeter taken from arterial blood samples from healthy human subjects. Following arterial
      cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject
      breathes while simultaneous measurements are recorded from the test pulse oximeters and
      arterial blood samples at targeted levels of saturation.
observational model: Case-Only
measure: Pulse oximetry measurements of saturation from the test device will be compared to CO-Oximetry measurements of arterial oxygen saturation to demonstrate that the test sensor meets the oxygen saturation accuracy specifications for SpO2.
time frame: up to 6 months
arm group label: Pulse Oximeter (the device)
description: The pulse oximetry devices were placed on subjects per the protocol. The subjects underwent gradual hypoxia and the output of the devices under test was compared to the SaO2 value as measured by a CO-Oximeter (the reference value), as outlined by ISO 80601, to ensure that the devices meet the specified performance claims.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric T Heyer, MD
role: Principal Investigator
affiliation: Medtronic - MITG
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypoxia
sharing ipd: No