<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/NCT04429906</url>
  </required_header>
  <id_info>
    <org_study_id>2020114-0604</org_study_id>
    <nct_id>NCT04429906</nct_id>
  </id_info>
  <brief_title>Diagnostic Study of Huami Smart Wearable Device</brief_title>
  <acronym>DSHWD</acronym>
  <official_title>Evaluation of Accuracy of Blood Oxygen Saturation Detection Function of Huami Smart Wearable Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Anhui Huami Information Technology Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a cross-sectional diagnostic study. In this study, wrist oxygen saturation (SwO2)&#xD;
      will be measured by Huami smart wearable device, SpO2 of pulse oxygen saturation monitor with&#xD;
      medical device registration certificate and SaO2 of arterial blood gas analysis will be used&#xD;
      as reference values. A total of 180 group data will be measured in 30~50 patients with SaO2/&#xD;
      SpO2 between 80%∽100%. The investigators aim to evaluate the accuracy of blood oxygen&#xD;
      saturation detection function of huami smart wearable device.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cross-sectional diagnostic study. 30~50 inpatient aged 18～85y with SaO2/ SpO2&#xD;
      between 80%∽100% will be recruited from the Department of Respiratory and Critical Care of&#xD;
      Peking University First Hospital. 180 group data ( 37 of SaO2/ SpO2 between 80%∽90%, 143 of&#xD;
      SaO2/ SpO2 between 90%∽100%) will be measured, with an average of 4-6 groups per patient.&#xD;
      Some clinical information such as demographic data, laboratory tests, comorbidity, smoking&#xD;
      habit and will be collected. Patients have their pulse oximetry measured multiple times using&#xD;
      a pulse oximeter/tabletop electrocardiograph with a medical device registration certificate,&#xD;
      and arterial blood gas analysis will be performed if required. While monitoring the pulse&#xD;
      oximetry, a Huami smart wearable device is worn on the ipsilateral wrist to determine blood&#xD;
      oxygen saturation. Primary outcome is the wearable device oximetry accuracy Arms (root mean&#xD;
      square value of the SwO2-RefSpO2 difference) using a medical device registration certificate&#xD;
      pulse oximetry monitor/tabletop ECG monitor as a reference..&#xD;
&#xD;
      The study protocol has been approved by the Peking University First Hospital Institutional&#xD;
      Review Board (IRB) (2020-114). Any protocol modifications will be submitted for the IRB&#xD;
      review and approval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Wearable device oximetry accuracy Arms</measure>
    <time_frame>30mins</time_frame>
    <description>Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.&#xD;
Pulse oximetry monitor/desktop ECG monitor with a medical device registration certificate was selected as reference device A. The mean value of qualified pulse oximetry measured by pulse oximetry monitor/desktop ECG monitor was used as control group A measurement.&#xD;
Wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wearable device blood oxygen saturation accuracy Arms</measure>
    <time_frame>30mins</time_frame>
    <description>Record the pulse oximetry and pulse rate values measured by the Huami Smart Wearable Pulse Oximetry Device. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.A carbon monoxide blood gas analyzer (CO-oximeter) was selected as reference device B. Arterial blood was sampled and arterial oxygen saturation (SaO2) was obtained from the blood gas analyzer as a control group B measurement.Wearable device blood oxygen saturation accuracy Arms (expressed as root mean square value of the SwO2-SaO2 difference) using a carbon monoxide - blood gas analyzer (CO-oximeter) as reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 90%-100%.</measure>
    <time_frame>30mins</time_frame>
    <description>When SpO2/SaO2 is at 90%-100%,wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference;wearable device blood oxygen saturation accuracy Arms (expressed as root mean square value of the SwO2-SaO2 difference) using a carbon monoxide - blood gas analyzer (CO-oximeter) as reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 80%-89%.</measure>
    <time_frame>30mins</time_frame>
    <description>when SpO2/SaO2 is at 80%-89%,wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference;wearable device blood oxygen saturation accuracy Arms (expressed as root mean square value of the SwO2-SaO2 difference) using a carbon monoxide - blood gas analyzer (CO-oximeter) as reference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation analysis of parameters that have an impact on the accuracy of blood oxygen saturation of wearable devices.</measure>
    <time_frame>30mins</time_frame>
    <description>When the test result is negative, evaluate the parameters that have an impact on the accuracy of blood oxygen saturation of wearable devices.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The variability of blood oxygen saturation of wearable devices tested three times.</measure>
    <time_frame>30mins</time_frame>
    <description>Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. Evaluate the variability of blood oxygen saturation of wearable devices tested three times.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Oxygen Saturation</condition>
  <arm_group>
    <arm_group_label>test group</arm_group_label>
    <description>Wear the pulse-oxygen monitoring finger set of the medical monitor while wearing the Huami Smart Wearable device on the ipsilateral wrist according to the instructions for use. The medical monitor displays a steady pulse oximetry level for at least 30 seconds, starts the first measurement, slides the main dial page of the wearable device to the &quot;Oxygen Saturation&quot; measurement interface, clicks the measurement button to start the single measurement of blood oxygen saturation. Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group A</arm_group_label>
    <description>Pulse oximetry monitor/desktop ECG monitor with a medical device registration certificate was selected as reference device A. The mean value of qualified pulse oximetry measured by pulse oximetry monitor/desktop ECG monitor within 2 minutes of each successive measurement of the Huami Smart Wearable Device was used as control group A measurement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group B</arm_group_label>
    <description>A carbon monoxide blood gas analyzer (CO-oximeter) was selected as reference device B. Arterial blood was sampled and arterial oxygen saturation (SaO2) was obtained from the blood gas analyzer as a control group B measurement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Huami smart wearable device</intervention_name>
    <description>Wear the pulse-oxygen monitoring finger set of the medical monitor while wearing the Huami Smart Wearable device on the ipsilateral wrist according to the instructions for use. The medical monitor displays a steady pulse oximetry level for at least 30 seconds, starts the first measurement, slides the main dial page of the wearable device to the &quot;Oxygen Saturation&quot; measurement interface, clicks the measurement button to start the single measurement of blood oxygen saturation. Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.</description>
    <arm_group_label>test group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inpatients in the Department of Respiratory and Critical Care at Peking University First&#xD;
        Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Inpatients in the Department of Respiratory and Critical Care at Peking University&#xD;
             First Hospital&#xD;
&#xD;
          2. Oxygen intake or no oxygen intake when enrolled: 80%≤SaO2/SpO2≤100%&#xD;
&#xD;
          3. Age between 18 and 85 years, either gender&#xD;
&#xD;
          4. COHb&lt;3%, MetHb&lt;2%;&#xD;
&#xD;
          5. Sign an informed consent or sign an informed consent by a legally authorized&#xD;
             representative;&#xD;
&#xD;
          6. Be willing and able to follow the research program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. current smokers or those exposed to high levels of carbon monoxide.&#xD;
&#xD;
          2. critically ill patients who are in a state of shock, resulting in peripheral&#xD;
             circulation disorders.&#xD;
&#xD;
          3. Patients with hypothermia below 35°C.&#xD;
&#xD;
          4. Patients with bilateral wrist and hand oedema, soft tissue damage to the wrist, skin&#xD;
             incomplete and unable to wear a watch/ bracelet.&#xD;
&#xD;
          5. Vascular blood supply abnormalities of both upper limbs (occlusion, thrombosis,&#xD;
             post-trauma, etc.), which affects the test results&#xD;
&#xD;
          6. Patients with bilateral upper extremity pigmentation affecting the test results;&#xD;
&#xD;
          7. Patients with limb mobility impairment due to severe cerebrovascular disease sequelae.&#xD;
&#xD;
          8. Patients with severe mental system disease that makes it impossible to cooperate with&#xD;
             the researchers.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guangfa Wang, MD.</last_name>
      <phone>13810644029</phone>
      <email>wangguangfa@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Jiping Liao, PhD.</last_name>
      <phone>13521714181</phone>
      <email>colorfulwing01@163.com</email>
    </contact_backup>
    <investigator>
      <last_name>Chunbo Zhang</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Zhu Tian</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Guangfa Wang</investigator_full_name>
    <investigator_title>Professor &amp; MD.</investigator_title>
  </responsible_party>
  <keyword>Oxygen saturation Smart wearable device Accuracy</keyword>
  <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/NCT04429906
org study id: 2020114-0604
nct id: NCT04429906
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a cross-sectional diagnostic study. In this study, wrist oxygen saturation (SwO2)
      will be measured by Huami smart wearable device, SpO2 of pulse oxygen saturation monitor with
      medical device registration certificate and SaO2 of arterial blood gas analysis will be used
      as reference values. A total of 180 group data will be measured in 30~50 patients with SaO2/
      SpO2 between 80%∽100%. The investigators aim to evaluate the accuracy of blood oxygen
      saturation detection function of huami smart wearable device.
This is a cross-sectional diagnostic study. 30~50 inpatient aged 18～85y with SaO2/ SpO2
      between 80%∽100% will be recruited from the Department of Respiratory and Critical Care of
      Peking University First Hospital. 180 group data ( 37 of SaO2/ SpO2 between 80%∽90%, 143 of
      SaO2/ SpO2 between 90%∽100%) will be measured, with an average of 4-6 groups per patient.
      Some clinical information such as demographic data, laboratory tests, comorbidity, smoking
      habit and will be collected. Patients have their pulse oximetry measured multiple times using
      a pulse oximeter/tabletop electrocardiograph with a medical device registration certificate,
      and arterial blood gas analysis will be performed if required. While monitoring the pulse
      oximetry, a Huami smart wearable device is worn on the ipsilateral wrist to determine blood
      oxygen saturation. Primary outcome is the wearable device oximetry accuracy Arms (root mean
      square value of the SwO2-RefSpO2 difference) using a medical device registration certificate
      pulse oximetry monitor/tabletop ECG monitor as a reference..

      The study protocol has been approved by the Peking University First Hospital Institutional
      Review Board (IRB) (2020-114). Any protocol modifications will be submitted for the IRB
      review and approval.
observational model: Other
time perspective: Cross-Sectional
measure: Wearable device oximetry accuracy Arms
time frame: 30mins
description: Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.
Pulse oximetry monitor/desktop ECG monitor with a medical device registration certificate was selected as reference device A. The mean value of qualified pulse oximetry measured by pulse oximetry monitor/desktop ECG monitor was used as control group A measurement.
Wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference.
measure: Wearable device blood oxygen saturation accuracy Arms
time frame: 30mins
description: Record the pulse oximetry and pulse rate values measured by the Huami Smart Wearable Pulse Oximetry Device. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.A carbon monoxide blood gas analyzer (CO-oximeter) was selected as reference device B. Arterial blood was sampled and arterial oxygen saturation (SaO2) was obtained from the blood gas analyzer as a control group B measurement.Wearable device blood oxygen saturation accuracy Arms (expressed as root mean square value of the SwO2-SaO2 difference) using a carbon monoxide - blood gas analyzer (CO-oximeter) as reference.
measure: Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 90%-100%.
time frame: 30mins
description: When SpO2/SaO2 is at 90%-100%,wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference;wearable device blood oxygen saturation accuracy Arms (expressed as root mean square value of the SwO2-SaO2 difference) using a carbon monoxide - blood gas analyzer (CO-oximeter) as reference.
measure: Accuracy of blood oxygen saturation of wearable devices when SpO2/SaO2 is at 80%-89%.
time frame: 30mins
description: when SpO2/SaO2 is at 80%-89%,wearable device oximetry accuracy Arms (root mean square value of the SwO2-RefSpO2 difference) using a medical device registration certificate pulse oximetry monitor/tabletop ECG monitor as a reference;wearable device blood oxygen saturation accuracy Arms (expressed as root mean square value of the SwO2-SaO2 difference) using a carbon monoxide - blood gas analyzer (CO-oximeter) as reference.
measure: Correlation analysis of parameters that have an impact on the accuracy of blood oxygen saturation of wearable devices.
time frame: 30mins
description: When the test result is negative, evaluate the parameters that have an impact on the accuracy of blood oxygen saturation of wearable devices.
measure: The variability of blood oxygen saturation of wearable devices tested three times.
time frame: 30mins
description: Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. Evaluate the variability of blood oxygen saturation of wearable devices tested three times.
arm group label: test group
description: Wear the pulse-oxygen monitoring finger set of the medical monitor while wearing the Huami Smart Wearable device on the ipsilateral wrist according to the instructions for use. The medical monitor displays a steady pulse oximetry level for at least 30 seconds, starts the first measurement, slides the main dial page of the wearable device to the "Oxygen Saturation" measurement interface, clicks the measurement button to start the single measurement of blood oxygen saturation. Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.
arm group label: control group A
description: Pulse oximetry monitor/desktop ECG monitor with a medical device registration certificate was selected as reference device A. The mean value of qualified pulse oximetry measured by pulse oximetry monitor/desktop ECG monitor within 2 minutes of each successive measurement of the Huami Smart Wearable Device was used as control group A measurement.
arm group label: control group B
description: A carbon monoxide blood gas analyzer (CO-oximeter) was selected as reference device B. Arterial blood was sampled and arterial oxygen saturation (SaO2) was obtained from the blood gas analyzer as a control group B measurement.
intervention type: Device
intervention name: Huami smart wearable device
description: Wear the pulse-oxygen monitoring finger set of the medical monitor while wearing the Huami Smart Wearable device on the ipsilateral wrist according to the instructions for use. The medical monitor displays a steady pulse oximetry level for at least 30 seconds, starts the first measurement, slides the main dial page of the wearable device to the "Oxygen Saturation" measurement interface, clicks the measurement button to start the single measurement of blood oxygen saturation. Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group.
arm group label: test group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Guangfa Wang
investigator title: Professor & MD.
sharing ipd: No