<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/NCT02973243</url>
  </required_header>
  <id_info>
    <org_study_id>YGB-816-VITALIII</org_study_id>
    <nct_id>NCT02973243</nct_id>
  </id_info>
  <brief_title>The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III</brief_title>
  <official_title>The Vital Signs to Identify, Target, and Assess Level (VITAL) Care Study III</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Healthcare</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effect of automated recording on frequency of recorded scores, number of&#xD;
      automated notifications and serious events.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The frequency of EWS scores, number of automated notifications and serious events performed&#xD;
      on a general ward is contingent on the quality and frequency of vital signs measurement like&#xD;
      respiratory rate. This is due to the EWS escalation schemes of hospitals with an acute&#xD;
      intervention team. Obtained sub-score trigger levels of vital signs contribute to higher and&#xD;
      more frequent scoring.&#xD;
&#xD;
      We examine the influence of different respiration rate sensor concepts and measurements on&#xD;
      scoring (NEWS and CREWS) and workflow in a typical UK gastroenterology and respiratory ward.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2016</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 2017</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>Number of NEWS Scores</measure>
    <time_frame>8-12 Weeks</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">446</enrollment>
  <condition>Cardiac Arrest</condition>
  <condition>Renal Failure</condition>
  <condition>Respiration Failure</condition>
  <condition>Myocardial Infarction</condition>
  <condition>Severe Sepsis</condition>
  <arm_group>
    <arm_group_label>Manual Respiration Rate Measurement</arm_group_label>
    <description>Patients with manually measured respiratory rate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Automatic Respiration Rate Measurement</arm_group_label>
    <description>Patients with automatically measured respiratory rate</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Automatic RR Measurement</intervention_name>
    <description>Different newly developed respiration rate sensors are applied at the bedside during the intervention phase which send data to the IntelliVue Guardian System.</description>
    <arm_group_label>Automatic Respiration Rate Measurement</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators plan to observe a non-probability, convenience sample of patients which&#xD;
        will consist primarily of acutely ill hospitalized adult patients (at least 18 years of&#xD;
        age). Study participants will be recruited from all eligible patients during the enrollment&#xD;
        period who are having vital signs monitoring performed as Standard of Care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients admitted to the study units during the period of data collection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  palliative patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian P Subbe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ysbyty Gwynedd Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ysbyty Gwynedd Hospital</name>
      <address>
        <city>Bangor</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <last_update_submitted>April 11, 2017</last_update_submitted>
  <last_update_submitted_qc>April 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>early warning scoring</keyword>
  <keyword>respiration rate</keyword>
  <keyword>acute care teams</keyword>
  <keyword>NEWS</keyword>
  <keyword>CREWS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <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/NCT02973243
org study id: YGB-816-VITALIII
nct id: NCT02973243
lead sponsor: 
has dmc: Yes
To evaluate the effect of automated recording on frequency of recorded scores, number of
      automated notifications and serious events.
The frequency of EWS scores, number of automated notifications and serious events performed
      on a general ward is contingent on the quality and frequency of vital signs measurement like
      respiratory rate. This is due to the EWS escalation schemes of hospitals with an acute
      intervention team. Obtained sub-score trigger levels of vital signs contribute to higher and
      more frequent scoring.

      We examine the influence of different respiration rate sensor concepts and measurements on
      scoring (NEWS and CREWS) and workflow in a typical UK gastroenterology and respiratory ward.
observational model: Cohort
time perspective: Prospective
measure: Number of NEWS Scores
time frame: 8-12 Weeks
arm group label: Manual Respiration Rate Measurement
description: Patients with manually measured respiratory rate
arm group label: Automatic Respiration Rate Measurement
description: Patients with automatically measured respiratory rate
intervention type: Device
intervention name: Automatic RR Measurement
description: Different newly developed respiration rate sensors are applied at the bedside during the intervention phase which send data to the IntelliVue Guardian System.
arm group label: Automatic Respiration Rate Measurement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christian P Subbe, MD
role: Principal Investigator
affiliation: Ysbyty Gwynedd Hospital
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Respiratory Insufficiency
mesh term: Myocardial Infarction
mesh term: Infarction
sharing ipd: No