<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/NCT03750318</url>
  </required_header>
  <id_info>
    <org_study_id>2018/2223 (Women)</org_study_id>
    <nct_id>NCT03750318</nct_id>
  </id_info>
  <brief_title>Validation Study on RENEW's Aingeal at KK Women's and Children's Hospital</brief_title>
  <acronym>RENEW</acronym>
  <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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance&#xD;
      Monitoring system within an adult in-patient setting 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: a patient-worn&#xD;
      wireless vital signs monitor (Aingeal) that transmits data over Wi-Fi to a central station&#xD;
      software platform (Surveillance Station). The Aingeal device measures single lead ECG, heart&#xD;
      rate, respiration waveform and rate, and skin temperature. A snapshot of data is transmitted&#xD;
      by the devices intermittently to the Surveillance Station, enabling vital signs trends to be&#xD;
      plotted. If any heart, respiration rate or skin temperature values move outside of&#xD;
      pre-defined high and low limits (individually set for each patient) an alert is raised. ECG&#xD;
      arrhythmia detection algorithms automatically record and send ECG data if the patient is&#xD;
      suspected to be experiencing an arrhythmia event (Asystole, Ventricular Fibrillation,&#xD;
      Tachycardia or Bradycardia). This proposal describes the evaluation of RENEW's Aingeal device&#xD;
      within an adult in-patient setting KK Women's and Children's Hospital (&quot;KKH&quot;), the main&#xD;
      tertiary women and children hospital in Singapore. User acceptance of Aingeal and the&#xD;
      Surveillance System will be considered within the clinical settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Actual">May 5, 2019</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 as part of an integrated monitoring with opioid delivery system at ward setting.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Respiratory alarm rate per patient per day</measure>
    <time_frame>3-4 days (upon admission till 1-3 days after surgery)</time_frame>
    <description>De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day derived.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Cardiac alarm rate per patient per day</measure>
    <time_frame>3-4 days (upon admission till 1-3 days after surgery)</time_frame>
    <description>De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of cardiac alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether cardiac alarms are defined as True or False, with an overall Alarm Rate per patient per day derived.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>False positive Respiratory alarm rate per patient per day</measure>
    <time_frame>3-4 days (upon admission till 1-3 days after surgery)</time_frame>
    <description>De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with False Positive Alarm Rate per patient per day derived.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>False positive Cardiac alarm rate per patient per day</measure>
    <time_frame>3-4 days (upon admission till 1-3 days after surgery)</time_frame>
    <description>De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of cardiac alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether cardiac alarms are defined as True or False, with False Positive Alarm Rate per patient per day derived.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">39</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 patients will wear the Aingeal device as part of the vital sign monitoring with opioid delivery system at ward setting.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vital sign monitoring</intervention_name>
    <description>Each patient will be set up for monitoring on admission. Duration of opioid therapy for post-operative in-patients may range from 1-3 days. Once opioid therapy is no longer required, Aingeal monitoring will be ended and each patient would be encouraged to have at least 1 day Aingeal monitoring to be recorded during the study. De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of alarms raised during monitoring. A sample of the data will be reviewed to determine whether cardiac and respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day and False Positive Alarm Rate per patient per day derived. Vital sign trend graphs for each patient will be produced.</description>
    <arm_group_label>Aingeal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult female patients, aged 21 years or over&#xD;
&#xD;
          -  Patients admitted to post-operative gynaecological ward at KKH Women's and Children's&#xD;
             Hospital, Singapore&#xD;
&#xD;
          -  Patients receiving opioid therapy via patient controlled analgesia (PCA)&#xD;
&#xD;
          -  Patients that are on electronic nursing charting&#xD;
&#xD;
          -  Patients that are on acute pain service monitoring&#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 (Heart Rate detection algorithm has not been designed to&#xD;
             reject foetal heart rate)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only women receiving gynaecological surgery in the mentioned hospital will be recruited.</gender_description>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ban Leong Sng, FANZCA</last_name>
    <role>Study Director</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 2023</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</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>Sng Ban Leong</investigator_full_name>
    <investigator_title>Head and Senior Consultant, Dept of Women's Anaesthesia</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/18/NCT03750318/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/NCT03750318
org study id: 2018/2223 (Women)
nct id: NCT03750318
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This proposal describes the evaluation of a CE-marked, FDA cleared vital signs Surveillance
      Monitoring system within an adult in-patient setting 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. If any heart, respiration rate or skin temperature values move outside of
      pre-defined high and low limits (individually set for each patient) an alert is raised. ECG
      arrhythmia detection algorithms automatically record and send ECG data if the patient is
      suspected to be experiencing an arrhythmia event (Asystole, Ventricular Fibrillation,
      Tachycardia or Bradycardia). This proposal describes the evaluation of RENEW's Aingeal device
      within an adult in-patient setting 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.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All patients recruited will be wearing the Aingeal device as part of an integrated monitoring with opioid delivery system at ward setting.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Overall Respiratory alarm rate per patient per day
time frame: 3-4 days (upon admission till 1-3 days after surgery)
description: De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day derived.
measure: Overall Cardiac alarm rate per patient per day
time frame: 3-4 days (upon admission till 1-3 days after surgery)
description: De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of cardiac alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether cardiac alarms are defined as True or False, with an overall Alarm Rate per patient per day derived.
measure: False positive Respiratory alarm rate per patient per day
time frame: 3-4 days (upon admission till 1-3 days after surgery)
description: De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of respiratory alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether respiratory alarms are defined as True or False, with False Positive Alarm Rate per patient per day derived.
measure: False positive Cardiac alarm rate per patient per day
time frame: 3-4 days (upon admission till 1-3 days after surgery)
description: De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of cardiac alarms raised during monitoring. A sample of the data will be reviewed against the nursing chart to determine whether cardiac alarms are defined as True or False, with False Positive Alarm Rate per patient per day derived.
arm group label: Aingeal
arm group type: Experimental
description: All patients will wear the Aingeal device as part of the vital sign monitoring with opioid delivery system at ward setting.
intervention type: Device
intervention name: Vital sign monitoring
description: Each patient will be set up for monitoring on admission. Duration of opioid therapy for post-operative in-patients may range from 1-3 days. Once opioid therapy is no longer required, Aingeal monitoring will be ended and each patient would be encouraged to have at least 1 day Aingeal monitoring to be recorded during the study. De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of alarms raised during monitoring. A sample of the data will be reviewed to determine whether cardiac and respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day and False Positive Alarm Rate per patient per day derived. Vital sign trend graphs for each patient will be produced.
arm group label: Aingeal
criteria: 
gender: Female
gender based: Yes
gender description: Only women receiving gynaecological surgery in the mentioned hospital will be recruited.
minimum age: 21 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ban Leong Sng, FANZCA
role: Study Director
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: Sng Ban Leong
investigator title: Head and Senior Consultant, Dept of Women's Anaesthesia
sharing ipd: No
provided document: 