<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/NCT03265756</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00072555</org_study_id>
    <nct_id>NCT03265756</nct_id>
  </id_info>
  <brief_title>Multimometer - Vital Signs Device for Diagnosis of Pneumonia</brief_title>
  <official_title>Multimometer - Vital Signs Device for Diagnosis of Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Grand Challenges Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</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>
      Pneumonia is a major cause of illness in young children. The investigators are developing and&#xD;
      testing a new thermometer like device called Multimometer, to measure the respiration rate&#xD;
      (RR), temperature, heart rate (HR) and the degree of blood oxygenation (SpO2) of children who&#xD;
      may suffer from pneumonia. These are called vital signs and their measurements greatly help&#xD;
      to diagnose pneumonia.&#xD;
&#xD;
      In the first part of the study, and in order to optimize and better align the size of the&#xD;
      device with the face, the investigators will measure the average size and dimensions of young&#xD;
      children's face. In the second part of the study, the investigators will compare the vital&#xD;
      signs measurements with measurements obtained by other commonly used devices in ill children&#xD;
      who are suspected to suffer from pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A. Improve the universality of the mouth-interface using facial anthropometry techniques.&#xD;
&#xD;
      For this first part of the study, the investigators will use a portable 3D camera (as&#xD;
      previously used by our group) to acquire 250 3D facial images of healthy children under 5yrs&#xD;
      of age in the DRC. While in hospital/clinic, the investigators will use a three-dimension&#xD;
      (3D) special camera to obtain an image of the child's face. The child can sit on the lap of&#xD;
      the parent and we will take the image. The image acquisition takes less than 30 seconds.&#xD;
      There are no specific requirements from the child, and the image can be taken if the child is&#xD;
      asleep or awake, cry or settled. No medical or identifying information will be collected.&#xD;
&#xD;
      All the computerized images will be cluster analyzed (using previously established&#xD;
      methodologies from the Technion, Israel) and three 3D average faces of all small, medium and&#xD;
      large faces will be constructed. The investigators will use these &quot;faces&quot; to design better&#xD;
      Multimometers with improved mouth-interface for this population.&#xD;
&#xD;
      B. Integrate into the current device a reflexive pulse oximeter sensor which will allow&#xD;
      measurements of oxygen saturation and heart rate.&#xD;
&#xD;
      For the addition of HR and SpO2 measurements, the investigators will integrate a reflective&#xD;
      pulse oximetry chip into the probe. Together with the manufacturer (RespiDx Inc., Israel) the&#xD;
      investigators will design and manufacture optimal prototype devices suitable for performing&#xD;
      clinical trials on this population.&#xD;
&#xD;
      C. Compare vital signs measurements by Multimometer® to simultaneous vital signs measurement&#xD;
      using conventional devices.&#xD;
&#xD;
      For this part of the study, repeated (x5 times) measurements of the 4 vital signs in 50 young&#xD;
      children (under 5 yrs) in hospital/clinics in Butembo DRC with suspected pneumonia, will be&#xD;
      recorded using the Multimometer. These signs will also be measured at the same time, by&#xD;
      conventional methods (regular thermometers for temperature, observed respiratory rate using&#xD;
      recorded chest movements and end-tidal carbon dioxide (CO2) for respiratory rate, standard&#xD;
      pulse oximeters for oxygen saturation and heart rate). All these measurements take less than&#xD;
      5 minutes. The investigators will repeat these sets approximately 5 times during the same day&#xD;
      in the hospital or during a clinic visit. The vital signs will be compared between the two&#xD;
      methods using Pearson's correlation coefficient and using Bland-Altman plots for agreement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2017</start_date>
  <completion_date type="Actual">September 30, 2018</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Vital Signs Comparison</measure>
    <time_frame>2018</time_frame>
    <description>Measurements of respiration rate, temperature, heart rate and the degree of blood oxygenation of children</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>3D facial images</measure>
    <time_frame>2017-2018</time_frame>
    <description>Measurements of facial dimensions and contour</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">350</enrollment>
  <condition>Pneumonia</condition>
  <arm_group>
    <arm_group_label>Healthy children</arm_group_label>
    <description>250 3D facial images of healthy children under 5yrs of age in the Democratic Republic of Congo (DRC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Suspected Pneumonia</arm_group_label>
    <description>50 young children (under 5 yrs) in hospital/clinics in Butembo DRC with suspected pneumonia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Multimometer</intervention_name>
    <description>A device for measuring respiration rate, temperature, heart rate and the degree of blood oxygenation of children</description>
    <arm_group_label>Suspected Pneumonia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children under 5y of age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For the first part of the study (3D facial images):&#xD;
&#xD;
        • Healthy children under 5y of age&#xD;
&#xD;
        For the second phase of the study (Comparison of vital signs):&#xD;
&#xD;
        • Children under 5y of age with suspected pneumonia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Children older than 5y of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Israel Amirav</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G2C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AHFIA (Association for Health Innovation in Africa)</name>
      <address>
        <city>Butembo</city>
        <state>North Kivu</state>
        <country>Congo, The Democratic Republic of the</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Congo, The Democratic Republic of the</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>August 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>November 19, 2018</last_update_submitted>
  <last_update_submitted_qc>November 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alberta</investigator_affiliation>
    <investigator_full_name>Israel Amirav</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03265756
org study id: Pro00072555
nct id: NCT03265756
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pneumonia is a major cause of illness in young children. The investigators are developing and
      testing a new thermometer like device called Multimometer, to measure the respiration rate
      (RR), temperature, heart rate (HR) and the degree of blood oxygenation (SpO2) of children who
      may suffer from pneumonia. These are called vital signs and their measurements greatly help
      to diagnose pneumonia.

      In the first part of the study, and in order to optimize and better align the size of the
      device with the face, the investigators will measure the average size and dimensions of young
      children's face. In the second part of the study, the investigators will compare the vital
      signs measurements with measurements obtained by other commonly used devices in ill children
      who are suspected to suffer from pneumonia.
A. Improve the universality of the mouth-interface using facial anthropometry techniques.

      For this first part of the study, the investigators will use a portable 3D camera (as
      previously used by our group) to acquire 250 3D facial images of healthy children under 5yrs
      of age in the DRC. While in hospital/clinic, the investigators will use a three-dimension
      (3D) special camera to obtain an image of the child's face. The child can sit on the lap of
      the parent and we will take the image. The image acquisition takes less than 30 seconds.
      There are no specific requirements from the child, and the image can be taken if the child is
      asleep or awake, cry or settled. No medical or identifying information will be collected.

      All the computerized images will be cluster analyzed (using previously established
      methodologies from the Technion, Israel) and three 3D average faces of all small, medium and
      large faces will be constructed. The investigators will use these "faces" to design better
      Multimometers with improved mouth-interface for this population.

      B. Integrate into the current device a reflexive pulse oximeter sensor which will allow
      measurements of oxygen saturation and heart rate.

      For the addition of HR and SpO2 measurements, the investigators will integrate a reflective
      pulse oximetry chip into the probe. Together with the manufacturer (RespiDx Inc., Israel) the
      investigators will design and manufacture optimal prototype devices suitable for performing
      clinical trials on this population.

      C. Compare vital signs measurements by Multimometer® to simultaneous vital signs measurement
      using conventional devices.

      For this part of the study, repeated (x5 times) measurements of the 4 vital signs in 50 young
      children (under 5 yrs) in hospital/clinics in Butembo DRC with suspected pneumonia, will be
      recorded using the Multimometer. These signs will also be measured at the same time, by
      conventional methods (regular thermometers for temperature, observed respiratory rate using
      recorded chest movements and end-tidal carbon dioxide (CO2) for respiratory rate, standard
      pulse oximeters for oxygen saturation and heart rate). All these measurements take less than
      5 minutes. The investigators will repeat these sets approximately 5 times during the same day
      in the hospital or during a clinic visit. The vital signs will be compared between the two
      methods using Pearson's correlation coefficient and using Bland-Altman plots for agreement.
observational model: Cohort
time perspective: Prospective
measure: Vital Signs Comparison
time frame: 2018
description: Measurements of respiration rate, temperature, heart rate and the degree of blood oxygenation of children
measure: 3D facial images
time frame: 2017-2018
description: Measurements of facial dimensions and contour
arm group label: Healthy children
description: 250 3D facial images of healthy children under 5yrs of age in the Democratic Republic of Congo (DRC).
arm group label: Suspected Pneumonia
description: 50 young children (under 5 yrs) in hospital/clinics in Butembo DRC with suspected pneumonia
intervention type: Device
intervention name: Multimometer
description: A device for measuring respiration rate, temperature, heart rate and the degree of blood oxygenation of children
arm group label: Suspected Pneumonia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Israel Amirav
role: Principal Investigator
affiliation: University of Alberta
facility: 
facility: 
country: Canada
country: Congo, The Democratic Republic of the
responsible party type: Principal Investigator
investigator affiliation: University of Alberta
investigator full name: Israel Amirav
investigator title: MD
mesh term: Pneumonia
sharing ipd: Undecided