<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/NCT03017742</url>
  </required_header>
  <id_info>
    <org_study_id>SUNE0002</org_study_id>
    <nct_id>NCT03017742</nct_id>
  </id_info>
  <brief_title>Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in the Emergency Department</brief_title>
  <official_title>A Multi-Center Study on the Utility of Non-invasive Carboxyhemoglobin and Total Hemoglobin Measurement in Emergency Department Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Masimo Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Masimo Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the clinical utility of triage screening for anemia&#xD;
      and carbon monoxide poisoning (COP) in the ED setting.This is a prospective, nonrandomized,&#xD;
      multi-center study of the performance of simultaneous non-invasive testing for two common&#xD;
      disorders (COP and anemia). We will determine the limits of agreement and performance&#xD;
      characteristics of non-invasive carboxyhemoglobin (SpCO) and hemoglobin (SpHb) values&#xD;
      compared to standard blood tests for measurement of carboxyhemoglobin and hemoglobin, in the&#xD;
      emergency department setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 11, 2017</completion_date>
  <primary_completion_date type="Actual">December 11, 2017</primary_completion_date>
  <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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference Between SpCO and COHb</measure>
    <time_frame>Up to 3 hours</time_frame>
    <description>Measure the difference between noninvasive carboxyhemoglobin (SpCO) and carboxyhemoglobin determined by co-oximeter measurement of blood (COHb) as calculated in terms of standard deviation.&#xD;
The average difference between paired Masimo noninvasive carboxyhemoglobin (SpCO) and reference carboxyhemoglobin (COHb) determined by co-oximeter measurement of blood represented as mean bias.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SpCO Detection of Carbon Monoxide Poisoning (COP)</measure>
    <time_frame>up to 3 hours</time_frame>
    <description>Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning</measure>
    <time_frame>up to 3 hours</time_frame>
    <description>Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration</measure>
    <time_frame>up to 3 hours</time_frame>
    <description>CO elimination will be evaluated as a function of administered oxygen.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity of SpHb in Detecting Anemia.</measure>
    <time_frame>up to 3 hours</time_frame>
    <description>Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensitivity of SpHb Detection of Anemia.</measure>
    <time_frame>up to 3 hours</time_frame>
    <description>Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SpHb Utility for Screening Anemia</measure>
    <time_frame>up to 3 hours</time_frame>
    <description>Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">813</enrollment>
  <condition>Carbon Monoxide Poisoning</condition>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Test Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects enrolled in the test group will receive the pulse oximeter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulse Oximeter</intervention_name>
    <arm_group_label>Test Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 1 year or older.&#xD;
&#xD;
          -  At least one digit has acceptable width as measured by study-provided digit gauge.&#xD;
&#xD;
          -  Presenting to emergency department for any complaint.&#xD;
&#xD;
          -  Potential for IV catheter and/or blood draw for CBC as standard of care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to consent for any reason&#xD;
&#xD;
          -  Patients with fingernail polish, discoloration or trauma to fingers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tepecik Training and Research Hospital IEC</name>
      <address>
        <city>Izmir</city>
        <zip>468</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <results_first_submitted>August 30, 2021</results_first_submitted>
  <results_first_submitted_qc>June 14, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 8, 2022</results_first_posted>
  <disposition_first_submitted>January 10, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>January 10, 2019</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 8, 2022</disposition_first_posted>
  <last_update_submitted>June 14, 2022</last_update_submitted>
  <last_update_submitted_qc>June 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 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>Emergencies</mesh_term>
    <mesh_term>Poisoning</mesh_term>
    <mesh_term>Carbon Monoxide Poisoning</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 19, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03017742/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Test Group</title>
          <description>The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="813"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="740"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Test Group</title>
          <description>The subjects enrolled in the test group will receive the pulse oximeter&#xD;
Pulse Oximeter</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="740"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="559"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="129"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="399"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="740"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="740"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Difference Between SpCO and COHb</title>
        <description>Measure the difference between noninvasive carboxyhemoglobin (SpCO) and carboxyhemoglobin determined by co-oximeter measurement of blood (COHb) as calculated in terms of standard deviation.&#xD;
The average difference between paired Masimo noninvasive carboxyhemoglobin (SpCO) and reference carboxyhemoglobin (COHb) determined by co-oximeter measurement of blood represented as mean bias.</description>
        <time_frame>Up to 3 hours</time_frame>
        <population>140 subjects excluded due to: 35 subjects: no valid reference COHb measurements available 17 subjects: no SpCO measurements available 65 subjects: COHb sample more than 10 minutes from the SpCO measurement. 22 subjects: low SpCO confidence value&#xD;
1 subject: invalid reference measurement (COHb) Target subject sample size of 3000 was not met to evaluate difference between SpCO and COHb. The results are reported in terms of standard deviation.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Group</title>
            <description>The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between SpCO and COHb</title>
          <description>Measure the difference between noninvasive carboxyhemoglobin (SpCO) and carboxyhemoglobin determined by co-oximeter measurement of blood (COHb) as calculated in terms of standard deviation.&#xD;
The average difference between paired Masimo noninvasive carboxyhemoglobin (SpCO) and reference carboxyhemoglobin (COHb) determined by co-oximeter measurement of blood represented as mean bias.</description>
          <population>140 subjects excluded due to: 35 subjects: no valid reference COHb measurements available 17 subjects: no SpCO measurements available 65 subjects: COHb sample more than 10 minutes from the SpCO measurement. 22 subjects: low SpCO confidence value&#xD;
1 subject: invalid reference measurement (COHb) Target subject sample size of 3000 was not met to evaluate difference between SpCO and COHb. The results are reported in terms of standard deviation.</population>
          <units>percent</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="600"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.01" spread="2.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>SpCO Detection of Carbon Monoxide Poisoning (COP)</title>
        <description>Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb.</description>
        <time_frame>up to 3 hours</time_frame>
        <population>Out of the 600 subjects that were analyzed from all that were enrolled, only 26 subjects met the criteria for carbon monoxide poisoning.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Group</title>
            <description>The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters</description>
          </group>
        </group_list>
        <measure>
          <title>SpCO Detection of Carbon Monoxide Poisoning (COP)</title>
          <description>Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb.</description>
          <population>Out of the 600 subjects that were analyzed from all that were enrolled, only 26 subjects met the criteria for carbon monoxide poisoning.</population>
          <units>percentage</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="600"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sensitivity of COP Detection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specificity of COP Detection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning</title>
        <description>Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity</description>
        <time_frame>up to 3 hours</time_frame>
        <population>Clinician survey were not conducted or collected to perform data analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Group</title>
            <description>The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters</description>
          </group>
        </group_list>
        <measure>
          <title>Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning</title>
          <description>Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity</description>
          <population>Clinician survey were not conducted or collected to perform data analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration</title>
        <description>CO elimination will be evaluated as a function of administered oxygen.</description>
        <time_frame>up to 3 hours</time_frame>
        <population>No COHb elimination pharmacokinetics data was collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Group</title>
            <description>The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters</description>
          </group>
        </group_list>
        <measure>
          <title>Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration</title>
          <description>CO elimination will be evaluated as a function of administered oxygen.</description>
          <population>No COHb elimination pharmacokinetics data was collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Specificity of SpHb in Detecting Anemia.</title>
        <description>Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.</description>
        <time_frame>up to 3 hours</time_frame>
        <population>Excluded subjects are shown below:&#xD;
20 subjects: no valid blood reference results 73 subjects: time between the first valid SpHb reading and the venous blood draw exceeded 10 minutes.&#xD;
32 subjects: low Perfusion Index quality. 3 subjects: low signal stability 26 subjects: low SpHb confidence 18 subjects : no SpHb result displayed. 21 subjects: user error&#xD;
1 subject: pregnant</population>
        <group_list>
          <group group_id="O1">
            <title>Test Group</title>
            <description>The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters</description>
          </group>
        </group_list>
        <measure>
          <title>Specificity of SpHb in Detecting Anemia.</title>
          <description>Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.</description>
          <population>Excluded subjects are shown below:&#xD;
20 subjects: no valid blood reference results 73 subjects: time between the first valid SpHb reading and the venous blood draw exceeded 10 minutes.&#xD;
32 subjects: low Perfusion Index quality. 3 subjects: low signal stability 26 subjects: low SpHb confidence 18 subjects : no SpHb result displayed. 21 subjects: user error&#xD;
1 subject: pregnant</population>
          <units>percentage of true negative</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sensitivity of SpHb Detection of Anemia.</title>
        <description>Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.</description>
        <time_frame>up to 3 hours</time_frame>
        <population>Excluded subjects are shown below:&#xD;
20 subjects: no valid blood reference results 73 subjects: time between the first valid SpHb reading and the venous blood draw exceeded 10 minutes.&#xD;
32 subjects: low Perfusion Index quality. 3 subjects: low signal stability 26 subjects: low SpHb confidence 18 subjects : no SpHb result displayed. 21 subjects: user error&#xD;
1 subject: pregnant</population>
        <group_list>
          <group group_id="O1">
            <title>Test Group</title>
            <description>The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters</description>
          </group>
        </group_list>
        <measure>
          <title>Sensitivity of SpHb Detection of Anemia.</title>
          <description>Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.</description>
          <population>Excluded subjects are shown below:&#xD;
20 subjects: no valid blood reference results 73 subjects: time between the first valid SpHb reading and the venous blood draw exceeded 10 minutes.&#xD;
32 subjects: low Perfusion Index quality. 3 subjects: low signal stability 26 subjects: low SpHb confidence 18 subjects : no SpHb result displayed. 21 subjects: user error&#xD;
1 subject: pregnant</population>
          <units>percent of true positives</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="546"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>SpHb Utility for Screening Anemia</title>
        <description>Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia</description>
        <time_frame>up to 3 hours</time_frame>
        <population>The number of subjects requirement defined by the study protocol were not met in this study, thus the threshold that predicts the outcome of &quot;acute treatment of anemia&quot; cannot be determined nor validated.</population>
        <group_list>
          <group group_id="O1">
            <title>Test Group</title>
            <description>The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters</description>
          </group>
        </group_list>
        <measure>
          <title>SpHb Utility for Screening Anemia</title>
          <description>Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia</description>
          <population>The number of subjects requirement defined by the study protocol were not met in this study, thus the threshold that predicts the outcome of &quot;acute treatment of anemia&quot; cannot be determined nor validated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were monitored throughout study duration, which was up to three hours.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Test Group</title>
          <description>The subjects enrolled in the test group will receive the pulse oximeter for various physiological parameters</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="813"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="813"/>
              </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="0" subjects_at_risk="813"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Cristina Johnson</name_or_title>
      <organization>Masimo Corporation</organization>
      <phone>(949) 297-7000</phone>
      <email>clinicalresearchdept@masimo.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/NCT03017742
org study id: SUNE0002
nct id: NCT03017742
lead sponsor: 
has dmc: No
is unapproved device: Yes
The purpose of this study is to determine the clinical utility of triage screening for anemia
      and carbon monoxide poisoning (COP) in the ED setting.This is a prospective, nonrandomized,
      multi-center study of the performance of simultaneous non-invasive testing for two common
      disorders (COP and anemia). We will determine the limits of agreement and performance
      characteristics of non-invasive carboxyhemoglobin (SpCO) and hemoglobin (SpHb) values
      compared to standard blood tests for measurement of carboxyhemoglobin and hemoglobin, in the
      emergency department setting.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Difference Between SpCO and COHb
time frame: Up to 3 hours
description: Measure the difference between noninvasive carboxyhemoglobin (SpCO) and carboxyhemoglobin determined by co-oximeter measurement of blood (COHb) as calculated in terms of standard deviation.
The average difference between paired Masimo noninvasive carboxyhemoglobin (SpCO) and reference carboxyhemoglobin (COHb) determined by co-oximeter measurement of blood represented as mean bias.
measure: SpCO Detection of Carbon Monoxide Poisoning (COP)
time frame: up to 3 hours
description: Diagnostics performance of SpCO for detecting COP measured by sensitivity and specificity compared to COHb.
measure: Utility of SpCO as a Screening Tool for Carbon Monoxide Poisoning
time frame: up to 3 hours
description: Surveying healthcare providers whether SpCO screening lead to identification of occult toxicity
measure: Carbon Monoxide (CO) Elimination Pharmacokinetics in Relation to Oxygen Administration
time frame: up to 3 hours
description: CO elimination will be evaluated as a function of administered oxygen.
measure: Specificity of SpHb in Detecting Anemia.
time frame: up to 3 hours
description: Specificity in detecting true non-anemic subjects as determined by co-oximeter reference analyzer.
measure: Sensitivity of SpHb Detection of Anemia.
time frame: up to 3 hours
description: Sensitivity in detecting true anemic subjects as determined by co-oximeter reference analyzer.
measure: SpHb Utility for Screening Anemia
time frame: up to 3 hours
description: Establish SpHb threshold that predicts the clinical outcome for acute treatment of anemia
arm group label: Test Group
arm group type: Experimental
description: The subjects enrolled in the test group will receive the pulse oximeter
intervention type: Device
intervention name: Pulse Oximeter
arm group label: Test Group
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
country: United States
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Poisoning
mesh term: Carbon Monoxide Poisoning
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 