<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/NCT03271216</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00066847</org_study_id>
    <nct_id>NCT03271216</nct_id>
  </id_info>
  <brief_title>Surveillance Monitoring on General Wards</brief_title>
  <official_title>Surveillance Monitoring on General Wards</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Masimo Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to determine if surveillance monitoring of general ward patients can reduce&#xD;
      cardio-pulmonary arrest while maintaining an acceptable false alarms rate for nursing&#xD;
      workload.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators placed a wired monitoring system (pulse oximetry, heart rate and&#xD;
      respiratory rate) on every patient who arrived on a subject general post surgical ward who&#xD;
      assented to wear the system. this was the Masimo PSNET system using the Radical 87 monitor&#xD;
      and an acoustic respiratory sensor along with a Masimo pulse oximetry probe. Patients were&#xD;
      monitored for a minimum of 48 hrs. Heart Rate (HR) parameters were set between 45-130,&#xD;
      Respiratory rate was set between 6-20 and pulse oximetrry was 85-100%. Nurses documented in&#xD;
      the Electronic Medical Record (EMR) any alarms they responded to as to whether they were&#xD;
      false (vital sign not out of range when rechecked) or true and what the response was.&#xD;
      Responses ranged from nurse managed to notification of primary service to Rapid Response&#xD;
      Activation to Code team activation as well as transfer to a higher level of care (operating&#xD;
      room or Intensive Care Unit (ICU)/IMC. Patient and Nursing satisfaction surveys were&#xD;
      collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>positive predictive value (PPV)</measure>
    <time_frame>6 months</time_frame>
    <description>The PPV of the wired monitoring system (pulse oximetry, heart rate and respiratory rate) will be determined based on change in vital signs (HR&lt;45 or &gt;130, RR&lt;6 or &gt;20 and pulse oximetry &lt;85) indicating clinical deterioration</description>
  </primary_outcome>
  <enrollment type="Actual">422</enrollment>
  <condition>Cardiac Arrest</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>no intervention</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Post-surgical patients on a general hospital ward&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all post-surgical patients admitted to a post-operative general hospital ward&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to understand English or provide verbal consent for data analysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>April 8, 2015</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <!-- 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/NCT03271216
org study id: IRB00066847
nct id: NCT03271216
lead sponsor: 
collaborator: 
has dmc: Yes
This is a study to determine if surveillance monitoring of general ward patients can reduce
      cardio-pulmonary arrest while maintaining an acceptable false alarms rate for nursing
      workload.
The investigators placed a wired monitoring system (pulse oximetry, heart rate and
      respiratory rate) on every patient who arrived on a subject general post surgical ward who
      assented to wear the system. this was the Masimo PSNET system using the Radical 87 monitor
      and an acoustic respiratory sensor along with a Masimo pulse oximetry probe. Patients were
      monitored for a minimum of 48 hrs. Heart Rate (HR) parameters were set between 45-130,
      Respiratory rate was set between 6-20 and pulse oximetrry was 85-100%. Nurses documented in
      the Electronic Medical Record (EMR) any alarms they responded to as to whether they were
      false (vital sign not out of range when rechecked) or true and what the response was.
      Responses ranged from nurse managed to notification of primary service to Rapid Response
      Activation to Code team activation as well as transfer to a higher level of care (operating
      room or Intensive Care Unit (ICU)/IMC. Patient and Nursing satisfaction surveys were
      collected.
observational model: Cohort
time perspective: Retrospective
measure: positive predictive value (PPV)
time frame: 6 months
description: The PPV of the wired monitoring system (pulse oximetry, heart rate and respiratory rate) will be determined based on change in vital signs (HR<45 or >130, RR<6 or >20 and pulse oximetry <85) indicating clinical deterioration
intervention type: Device
intervention name: No intervention
description: no intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Heart Arrest