<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/NCT02247765</url>
  </required_header>
  <id_info>
    <org_study_id>COVMOPR0445</org_study_id>
    <nct_id>NCT02247765</nct_id>
  </id_info>
  <brief_title>Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion</brief_title>
  <official_title>Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion in Healthy, Well Perfused 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>
      To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject&#xD;
      population during motion over a specified saturation range.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Use an investigational oximetry system to evaluate the triggering of the &quot;sensor off&quot; status&#xD;
      with marketed, off-the-shelf sensors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SpO2 Accuracy During Motion Conditions - MaxA Sensor</measure>
    <time_frame>up to 6 months</time_frame>
    <description>For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SpO2 Accuracy During Motion Conditions - MaxN Sensor</measure>
    <time_frame>up to 6 months</time_frame>
    <description>For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Healthy</condition>
  <condition>Hypoxia</condition>
  <arm_group>
    <arm_group_label>Arterial Line</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CO-Oximetry value obtained as a comparator. Obtained during motion conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Motion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subject has to perform motions during the procedure. This is to verify that device is able to read through motion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Arterial line</intervention_name>
    <description>Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601</description>
    <arm_group_label>Arterial Line</arm_group_label>
    <other_name>CO-Oximeter SaO2 value</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Motion</intervention_name>
    <description>The subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure.</description>
    <arm_group_label>Motion</arm_group_label>
  </intervention>
  <eligibility>
    <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;
          -  A room-air baseline % modulation &lt; 1.5% on all four fingers on the test hand&#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;
          -  Ventricular premature complexes (VPC's) 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;
             sites 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 or sleep&#xD;
             apnea&#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 or artificial nails from test&#xD;
             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;
&#xD;
          -  History of bleeding disorders or personal history of prolonged bleeding from injury.&#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 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>
    <facility>
      <name>Covidien RMS</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>March 2017</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>February 15, 2016</results_first_submitted>
  <results_first_submitted_qc>March 21, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 5, 2017</results_first_posted>
  <last_update_submitted>March 21, 2017</last_update_submitted>
  <last_update_submitted_qc>March 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2017</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>USB Pulse Oximetry Monitor Interface Cable</title>
          <description>Additional interventions include the following: Radial Arterial Line placement involves introduction of a standard arterial catheter or angiocath into the radial artery. Since the arterial catheter is placed into the artery using a needle, there will be mild to moderate discomfort. The total amount of blood drawn during the procedure is less than 100cc.&#xD;
Additionally, subjects are asked to perform motions with their hand. Standard motions include tapping and rubbing at aperiodic intervals with amplitudes of 1-2 cm and 1-4 Hz with a random variation in frequency. The subject is instructed to tap (or rub) with finger tips to maintain consistency of area of effect on the pressure pad and to prevent resting hand on pressure pad between motions so that only qualified taps are recorded by the pressure pad system. Each plateau will have both an interval of tapping and rubbing.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>no Treatment</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.67" spread="8.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>SpO2 Accuracy During Motion Conditions - MaxA Sensor</title>
        <description>For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.</description>
        <time_frame>up to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>no Treatment</title>
          </group>
        </group_list>
        <measure>
          <title>SpO2 Accuracy During Motion Conditions - MaxA Sensor</title>
          <description>For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.</description>
          <units>Accuracy Root Mean Square</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>SpO2 Accuracy During Motion Conditions - MaxN Sensor</title>
        <description>For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.</description>
        <time_frame>up to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>no Treatment</title>
          </group>
        </group_list>
        <measure>
          <title>SpO2 Accuracy During Motion Conditions - MaxN Sensor</title>
          <description>For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.</description>
          <units>Accuracy Root Mean Square</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>no Treatment</title>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>mild IV infiltration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Michael Luna-Victoria</name_or_title>
      <organization>Medtronic</organization>
      <phone>3034068955</phone>
      <email>michael.luna-victoria@medtronic.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02247765
org study id: COVMOPR0445
nct id: NCT02247765
lead sponsor: 
has dmc: No
To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject
      population during motion over a specified saturation range.
Use an investigational oximetry system to evaluate the triggering of the "sensor off" status
      with marketed, off-the-shelf sensors.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: SpO2 Accuracy During Motion Conditions - MaxA Sensor
time frame: up to 6 months
description: For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit.
measure: SpO2 Accuracy During Motion Conditions - MaxN Sensor
time frame: up to 6 months
description: For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit.
arm group label: Arterial Line
arm group type: Experimental
description: CO-Oximetry value obtained as a comparator. Obtained during motion conditions.
arm group label: Motion
arm group type: Experimental
description: The subject has to perform motions during the procedure. This is to verify that device is able to read through motion.
intervention type: Device
intervention name: Arterial line
description: Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601
arm group label: Arterial Line
other name: CO-Oximeter SaO2 value
intervention type: Device
intervention name: Motion
description: The subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure.
arm group label: Motion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Heyer, MD
role: Principal Investigator
affiliation: Medtronic - MITG
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypoxia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 