<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/NCT01720355</url>
  </required_header>
  <id_info>
    <org_study_id>COVMOPR0377</org_study_id>
    <nct_id>NCT01720355</nct_id>
  </id_info>
  <brief_title>Pulse Oximetry- Performance During Severe Signal Interference</brief_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>
      Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse&#xD;
      subject population during severe signal interference over a specified saturation range.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>SpO2 Accuracy (percentage of blood oxygen saturation)</measure>
    <time_frame>1.5 hours per subject</time_frame>
  </primary_outcome>
  <enrollment type="Actual">17</enrollment>
  <condition>Healthy Subjects</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy, well perfused&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects between the ages of 18 to 50 years (inclusive).&#xD;
&#xD;
          2. Must undergo a physical examination by a licensed physician, advanced practice nurse&#xD;
             or physician assistant, including a 12 lead ECG, a medical history, and a blood test&#xD;
             checking complete blood count and screening for sickle cell trait or disease&#xD;
&#xD;
          3. All female volunteers must have a negative urine pregnancy test prior to&#xD;
             participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A room-air baseline % modulation &lt; 1.5% on all four fingers on the test hand&#xD;
&#xD;
          2. Pregnancy or lactating women&#xD;
&#xD;
          3. History of syncopal episodes&#xD;
&#xD;
          4. Hypertension (defined as a systolic pressure of &gt;145 mmHg or a diastolic pressure &gt;90&#xD;
             mm Hg on three consecutive readings)&#xD;
&#xD;
          5. Premature ventricular contractions (PVC's) that are symptomatic or occur at a rate of&#xD;
             more than 5/minute&#xD;
&#xD;
          6. History of seizures (except childhood febrile seizures) or epilepsy&#xD;
&#xD;
          7. Routine use of tranquilizers and/or excessive anxiety&#xD;
&#xD;
          8. History of frequent headaches or migraines&#xD;
&#xD;
          9. History of stroke&#xD;
&#xD;
         10. Previous injury or trauma to fingers or hands that may change blood flow or vascular&#xD;
             supply and affect our ability to test multiple sensors&#xD;
&#xD;
         11. History of &quot;altitude sickness&quot; defined as headaches, malaise or dizziness when in the&#xD;
             mountains or in an aircraft at altitude significantly above sea level for a prolonged&#xD;
             period of time (&gt; 1 hour)&#xD;
&#xD;
         12. History of significant respiratory disease, such as severe asthma, emphysema, etc.&#xD;
&#xD;
         13. Sickle cell disease or trait.&#xD;
&#xD;
         14. The use of medications, pre-existing medical conditions, treatment for a medical&#xD;
             condition or any other reason deemed relevant by the clinician conducting the study.&#xD;
&#xD;
         15. A 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 designee.&#xD;
&#xD;
         16. Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g.,&#xD;
             Novocain)&#xD;
&#xD;
         17. Prior or known allergies to heparin&#xD;
&#xD;
         18. History of transient ischemic attacks or carotid artery disease&#xD;
&#xD;
         19. History of myocardial ischemia, angina, myocardial infarction, congestive heart&#xD;
             failure or cardiomyopathy&#xD;
&#xD;
         20. History of chronic renal impairment&#xD;
&#xD;
         21. History of recent arterial cannulation (less than 1 month prior to study)&#xD;
&#xD;
         22. History of complications from previous arterial cannulation&#xD;
&#xD;
         23. Current use of blood thinners&#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>
  <location>
    <facility>
      <name>Covidien</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>February 2013</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>February 12, 2013</last_update_submitted>
  <last_update_submitted_qc>February 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 13, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01720355
org study id: COVMOPR0377
nct id: NCT01720355
lead sponsor: 
has dmc: No
Determine accuracy specifications and labeling claims of a pulse oximeter in a diverse
      subject population during severe signal interference over a specified saturation range.
time perspective: Prospective
measure: SpO2 Accuracy (percentage of blood oxygen saturation)
time frame: 1.5 hours per subject
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor