<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/NCT03754231</url>
  </required_header>
  <id_info>
    <org_study_id>2018/2223 (Paediatric)</org_study_id>
    <nct_id>NCT03754231</nct_id>
  </id_info>
  <brief_title>Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital</brief_title>
  <official_title>Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KK Women's and Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Renew Group</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>KK Women's and Children's Hospital</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>
      This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance&#xD;
      Monitoring system in a paediatric outpatient population in KK Women's and Children's Hospital&#xD;
      (&quot;KKH&quot;), the main tertiary women and children hospital in Singapore. User acceptance of&#xD;
      Aingeal and the Surveillance System will be considered within the clinical settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      RENEW's Surveillance Monitoring system is made up of two main components:&#xD;
&#xD;
      a patient-worn wireless vital signs monitor (Aingeal) that transmits data over Wi-Fi to a&#xD;
      central station software platform (Surveillance Station). The Aingeal device measures single&#xD;
      lead ECG, heart rate, respiration waveform and rate, and skin temperature. A snapshot of data&#xD;
      is transmitted by the devices intermittently to the Surveillance Station, enabling vital&#xD;
      signs trends to be plotted. This proposal describes the evaluation of RENEW's Aingeal device&#xD;
      in a paediatric outpatient population in KK Women's and Children's Hospital (&quot;KKH&quot;), the main&#xD;
      tertiary women and children hospital in Singapore. In the paediatric population, assessment&#xD;
      of RENEW's Aingeal device will include the accuracy of the device at deriving heart rate from&#xD;
      single lead ECG and at deriving respiratory rate when compared against a commonly used vital&#xD;
      signs monitor. User acceptance of Aingeal and the Surveillance System will be considered&#xD;
      within the clinical settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2018</start_date>
  <completion_date type="Actual">December 1, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <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>
    <intervention_model_description>All patients recruited will be wearing the Aingeal device at a paediatric outpatient clinic setting.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart rate comparison</measure>
    <time_frame>15 minutes</time_frame>
    <description>Heart rate is calculated manually via ECG waveform and compared against the Aingeal device using Bland Altman approach</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory rate comparison</measure>
    <time_frame>15 minutes</time_frame>
    <description>Repiratory rate measurement is compared between Aingeal device and Capnostream device using Bland Altman approach.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Vital Sign</condition>
  <condition>Heart Rate</condition>
  <condition>Respiratory Rate</condition>
  <arm_group>
    <arm_group_label>Aingeal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All recruited patients will wear the Aingeal device as a form of heart rate monitoring and respiratory rate monitoring in a paediatric outpatient clinic setting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Heart rate monitoring</intervention_name>
    <description>The heart rate of recruited patients will be monitored for 15 minutes over 2 phases:&#xD;
i) 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing</description>
    <arm_group_label>Aingeal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Respiratory rate monitoring</intervention_name>
    <description>The heart rate of recruited patients will be monitored for 15 minutes over 2 phases:&#xD;
i) 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing</description>
    <arm_group_label>Aingeal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female paediatric patients, aged between 3 and 17 years&#xD;
&#xD;
          -  Patients attending outpatient care at KK Women's and Children's Hospital, Singapore&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with active, implantable devices (such as a pacemaker or ICD)&#xD;
&#xD;
          -  Patients with any skin condition or injury affecting the electrode placement site&#xD;
&#xD;
          -  Patients that are pregnant&#xD;
&#xD;
          -  Those patients who, in the opinion of the clinic staff, are not suitable to&#xD;
             participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bao Bei Kelly Low</last_name>
    <role>Principal Investigator</role>
    <affiliation>KK Women's and Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KK Women's and Children's Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>229899</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KK Women's and Children's Hospital</investigator_affiliation>
    <investigator_full_name>Low Bao Bei Kelly</investigator_full_name>
    <investigator_title>Associate Consultant, Department of Paediatrics</investigator_title>
  </responsible_party>
  <keyword>Vital sign monitoring</keyword>
  <keyword>Heart rate</keyword>
  <keyword>Respiratory rate</keyword>
  <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>April 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03754231/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03754231
org study id: 2018/2223 (Paediatric)
nct id: NCT03754231
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance
      Monitoring system in a paediatric outpatient population in KK Women's and Children's Hospital
      ("KKH"), the main tertiary women and children hospital in Singapore. User acceptance of
      Aingeal and the Surveillance System will be considered within the clinical settings.
RENEW's Surveillance Monitoring system is made up of two main components:

      a patient-worn wireless vital signs monitor (Aingeal) that transmits data over Wi-Fi to a
      central station software platform (Surveillance Station). The Aingeal device measures single
      lead ECG, heart rate, respiration waveform and rate, and skin temperature. A snapshot of data
      is transmitted by the devices intermittently to the Surveillance Station, enabling vital
      signs trends to be plotted. This proposal describes the evaluation of RENEW's Aingeal device
      in a paediatric outpatient population in KK Women's and Children's Hospital ("KKH"), the main
      tertiary women and children hospital in Singapore. In the paediatric population, assessment
      of RENEW's Aingeal device will include the accuracy of the device at deriving heart rate from
      single lead ECG and at deriving respiratory rate when compared against a commonly used vital
      signs monitor. User acceptance of Aingeal and the Surveillance System will be considered
      within the clinical settings.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All patients recruited will be wearing the Aingeal device at a paediatric outpatient clinic setting.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Heart rate comparison
time frame: 15 minutes
description: Heart rate is calculated manually via ECG waveform and compared against the Aingeal device using Bland Altman approach
measure: Respiratory rate comparison
time frame: 15 minutes
description: Repiratory rate measurement is compared between Aingeal device and Capnostream device using Bland Altman approach.
arm group label: Aingeal
arm group type: Experimental
description: All recruited patients will wear the Aingeal device as a form of heart rate monitoring and respiratory rate monitoring in a paediatric outpatient clinic setting.
intervention type: Other
intervention name: Heart rate monitoring
description: The heart rate of recruited patients will be monitored for 15 minutes over 2 phases:
i) 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing
arm group label: Aingeal
intervention type: Other
intervention name: Respiratory rate monitoring
description: The heart rate of recruited patients will be monitored for 15 minutes over 2 phases:
i) 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing
arm group label: Aingeal
criteria: 
gender: All
minimum age: 3 Years
maximum age: 17 Years
healthy volunteers: No
last name: Bao Bei Kelly Low
role: Principal Investigator
affiliation: KK Women's and Children's Hospital
facility: 
country: Singapore
responsible party type: Principal Investigator
investigator affiliation: KK Women's and Children's Hospital
investigator full name: Low Bao Bei Kelly
investigator title: Associate Consultant, Department of Paediatrics
sharing ipd: No
provided document: 