<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/NCT03039738</url>
  </required_header>
  <id_info>
    <org_study_id>COVMOPO0561</org_study_id>
    <nct_id>NCT03039738</nct_id>
  </id_info>
  <brief_title>Surveillance Monitoring as an Alternative to Telemetry</brief_title>
  <official_title>A Prospective Evaluation of Surveillance Monitoring as an Alternative to Telemetry in Patients Scheduled for Telemetry Without American Heart Association (AHA) Indication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic - MITG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the impact of surveillance monitoring versus&#xD;
      telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be single-center, prospective, pilot, pre/post implementation study to collect&#xD;
      post-market data on hospitalized subjects monitored via telemetry and surveillance monitoring&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Medtronic shift in strategic direction for study device&#xD;
  </why_stopped>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">January 4, 2018</completion_date>
  <primary_completion_date type="Actual">January 4, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Length of Stay (LOS) as Assessed by Review of Medical Records</measure>
    <time_frame>Baseline to end of hospital stay (or up to 30 day post enrollment)</time_frame>
    <description>LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Associated Health Care Costs (HCC) as Determined by Review of Billing Records</measure>
    <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
    <description>Health Care Costs will be determined by comparing HCC between the surveillance monitoring and telemetry monitoring arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records</measure>
    <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
    <description>Hospital Unit Transfers (HUT) will be determined by comparing the number of hospital unit transfers between monitoring arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Stay (LOS) in the ICU as Determined by Review of Medical Records</measure>
    <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
    <description>Length of Stay in the ICU will be determined by comparing numbers between monitoring arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records</measure>
    <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
    <description>CI include Rapid Response Team calls and Code Blue Activations. The Number of Clinical Interventions will be determined by comparing numbers between monitoring arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only</measure>
    <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
    <description>Time of Rapid Response Team (RRT) will be determined by comparing the number of RRT interventions between monitoring arms (only for surveillance monitoring arm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires</measure>
    <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
    <description>Clinical Team and Patient Satisfaction will be determined by comparing the Qualitative Questionnaire response between monitoring arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires</measure>
    <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
    <description>Number of clinicians &quot;very familiar&quot; and &quot;somewhat familiar&quot; with AHA guidelines was reported. The questionnaire was administered to all clinicians (e.g. ED physicians, nurses, critical care nurses, intensivists, and hospitalists) involved in the care of study participants at each hospital; it was not administered to study subjects.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">206</enrollment>
  <condition>Telemetry</condition>
  <condition>Patient Monitoring</condition>
  <arm_group>
    <arm_group_label>Telemetry Monitoring Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surveillance Monitoring Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vital Sync IM &amp; VPMP (Surveillance Monitoring)</intervention_name>
    <description>The Vital Sync™ Informatics Manager (IM) &amp; Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.</description>
    <arm_group_label>Surveillance Monitoring Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Telemetry Monitoring</intervention_name>
    <description>Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.</description>
    <arm_group_label>Telemetry Monitoring Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed and dated informed consent by subject&#xD;
&#xD;
          2. Male or female 18 years of age or older&#xD;
&#xD;
          3. Expected hospitalized admission on the general care floor or medical surgical unit for&#xD;
             at least one overnight stay and/or &gt; 12 hours&#xD;
&#xD;
          4. Scheduled for telemetry monitoring&#xD;
&#xD;
          5. Diagnosis indicates American Heart Association (AHA) telemetry Class III or none and&#xD;
             therefore not indicated for telemetry monitoring&#xD;
&#xD;
          6. For surveillance monitoring group subjects, treating provider who scheduled subject&#xD;
             for telemetry agrees to alternative monitoring plan of surveillance monitoring&#xD;
&#xD;
          7. Willingness to have study devices attached and hair shaved at sensor location as&#xD;
             needed during study participation&#xD;
&#xD;
          8. Willingness to participate in all aspects of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Implanted pacemaker or atrial defibrillator&#xD;
&#xD;
          2. Allergy or sensitivity to ECG leads or adhesives that are similar to ECG leads&#xD;
&#xD;
          3. Current AHA Class I or II indication/prescription for telemetry monitoring&#xD;
&#xD;
          4. Prescription for other continuous condition monitoring such as capnography or pulse&#xD;
             oximetry&#xD;
&#xD;
          5. Ongoing opioid therapy by patient-controlled analgesia (PCA), by epidural or&#xD;
             intrathecal infusions or by intravenous analgesia, per Investigator discretion&#xD;
&#xD;
          6. Ventilated or intubated patients at the time of enrollment&#xD;
&#xD;
          7. Female subject is pregnant, lactating, trying to get pregnant, or has a positive&#xD;
             pregnancy test for women with childbearing potential&#xD;
&#xD;
          8. Condition that, in the opinion of the investigator, may prevent completion of the&#xD;
             study or protocol requirements&#xD;
&#xD;
          9. Subject is considered as being morbidly obese (defined as BMI &gt;50.0)&#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>Stacey House, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University in Saint Louis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University in Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <results_first_submitted>December 7, 2018</results_first_submitted>
  <results_first_submitted_qc>April 3, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 29, 2019</results_first_posted>
  <last_update_submitted>April 29, 2019</last_update_submitted>
  <last_update_submitted_qc>April 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 9, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03039738/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT03039738/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Telemetry Monitoring Arm</title>
          <description>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.&#xD;
Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.</description>
        </group>
        <group group_id="P2">
          <title>Surveillance Monitoring Arm</title>
          <description>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.&#xD;
Vital Sync IM &amp; VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) &amp; Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="206"/>
                <participants group_id="P2" count="0">This arm did not initiate. The study was terminated following the completion of the telemetry phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="152"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Incomplete data sets</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Surveillance Monitoring Arm did not initiate as the study was terminated following the completion of the TM phase.</population>
      <group_list>
        <group group_id="B1">
          <title>Telemetry Monitoring Arm</title>
          <description>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.&#xD;
Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.</description>
        </group>
        <group group_id="B2">
          <title>Surveillance Monitoring Arm</title>
          <description>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.&#xD;
Vital Sync IM &amp; VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) &amp; Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="206"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="206"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.2" spread="15.6"/>
                    <measurement group_id="B3" value="55.3" spread="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B3" value="107"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="202"/>
                    <measurement group_id="B3" value="202"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="152"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.8" spread="9.2"/>
                    <measurement group_id="B3" value="28.8" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hospital Length of Stay (LOS) as Assessed by Review of Medical Records</title>
        <description>LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms.</description>
        <time_frame>Baseline to end of hospital stay (or up to 30 day post enrollment)</time_frame>
        <population>The study was prematurely terminated; no conclusion should be drawn from the reported data. Data for SM arm were not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Telemetry Monitoring (TM) Arm</title>
            <description>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.&#xD;
Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.</description>
          </group>
          <group group_id="O2">
            <title>Surveillance Monitoring (SM) Arm</title>
            <description>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.&#xD;
Vital Sync IM &amp; VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) &amp; Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay (LOS) as Assessed by Review of Medical Records</title>
          <description>LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms.</description>
          <population>The study was prematurely terminated; no conclusion should be drawn from the reported data. Data for SM arm were not collected.</population>
          <units>hrs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.9" spread="73.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Associated Health Care Costs (HCC) as Determined by Review of Billing Records</title>
        <description>Health Care Costs will be determined by comparing HCC between the surveillance monitoring and telemetry monitoring arms</description>
        <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
        <population>The study was prematurely terminated; the billing data for both TM and SM arms were not collected, and outcome measure analysis was not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Telemetry Monitoring (TM) Arm</title>
            <description>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.&#xD;
Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.</description>
          </group>
          <group group_id="O2">
            <title>Surveillance Monitoring (SM) Arm</title>
            <description>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.&#xD;
Vital Sync IM &amp; VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) &amp; Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Associated Health Care Costs (HCC) as Determined by Review of Billing Records</title>
          <description>Health Care Costs will be determined by comparing HCC between the surveillance monitoring and telemetry monitoring arms</description>
          <population>The study was prematurely terminated; the billing data for both TM and SM arms were not collected, and outcome measure analysis was not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records</title>
        <description>Hospital Unit Transfers (HUT) will be determined by comparing the number of hospital unit transfers between monitoring arms.</description>
        <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
        <population>The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data.</population>
        <group_list>
          <group group_id="O1">
            <title>Telemetry Monitoring (TM) Arm</title>
            <description>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.&#xD;
Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.</description>
          </group>
          <group group_id="O2">
            <title>Surveillance Monitoring (SM) Arm</title>
            <description>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.&#xD;
Vital Sync IM &amp; VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) &amp; Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records</title>
          <description>Hospital Unit Transfers (HUT) will be determined by comparing the number of hospital unit transfers between monitoring arms.</description>
          <population>The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Stay (LOS) in the ICU as Determined by Review of Medical Records</title>
        <description>Length of Stay in the ICU will be determined by comparing numbers between monitoring arms.</description>
        <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
        <population>The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data. Only participants who were admitted to ICU, were assessed for this Outcome.</population>
        <group_list>
          <group group_id="O1">
            <title>Telemetry Monitoring (TM) Arm</title>
            <description>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.&#xD;
Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.</description>
          </group>
          <group group_id="O2">
            <title>Surveillance Monitoring (SM) Arm</title>
            <description>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.&#xD;
Vital Sync IM &amp; VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) &amp; Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay (LOS) in the ICU as Determined by Review of Medical Records</title>
          <description>Length of Stay in the ICU will be determined by comparing numbers between monitoring arms.</description>
          <population>The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data. Only participants who were admitted to ICU, were assessed for this Outcome.</population>
          <units>hrs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records</title>
        <description>CI include Rapid Response Team calls and Code Blue Activations. The Number of Clinical Interventions will be determined by comparing numbers between monitoring arms.</description>
        <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
        <population>The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data.</population>
        <group_list>
          <group group_id="O1">
            <title>Telemetry Monitoring (TM) Arm</title>
            <description>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.&#xD;
Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.</description>
          </group>
          <group group_id="O2">
            <title>Surveillance Monitoring (SM) Arm</title>
            <description>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.&#xD;
Vital Sync IM &amp; VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) &amp; Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records</title>
          <description>CI include Rapid Response Team calls and Code Blue Activations. The Number of Clinical Interventions will be determined by comparing numbers between monitoring arms.</description>
          <population>The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="152"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only</title>
        <description>Time of Rapid Response Team (RRT) will be determined by comparing the number of RRT interventions between monitoring arms (only for surveillance monitoring arm)</description>
        <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
        <population>The study was prematurely terminated; this outcome was for Surveillance Monitoring arm only. The data were not collected, and no outcome measure analysis was performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Telemetry Monitoring (TM) Arm</title>
            <description>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.&#xD;
Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.</description>
          </group>
          <group group_id="O2">
            <title>Surveillance Monitoring (SM) Arm</title>
            <description>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.&#xD;
Vital Sync IM &amp; VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) &amp; Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only</title>
          <description>Time of Rapid Response Team (RRT) will be determined by comparing the number of RRT interventions between monitoring arms (only for surveillance monitoring arm)</description>
          <population>The study was prematurely terminated; this outcome was for Surveillance Monitoring arm only. The data were not collected, and no outcome measure analysis was performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires</title>
        <description>Clinical Team and Patient Satisfaction will be determined by comparing the Qualitative Questionnaire response between monitoring arms.</description>
        <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
        <population>The patient and clinical team satisfaction questionnaires were designed to be collected for the SM arm only. The study enrolled control arm only prior to termination. The questionnaires were not collected, and no outcome measure analyses were performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Telemetry Monitoring (TM) Arm</title>
            <description>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.&#xD;
Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.</description>
          </group>
          <group group_id="O2">
            <title>Surveillance Monitoring (SM) Arm</title>
            <description>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.&#xD;
Vital Sync IM &amp; VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) &amp; Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires</title>
          <description>Clinical Team and Patient Satisfaction will be determined by comparing the Qualitative Questionnaire response between monitoring arms.</description>
          <population>The patient and clinical team satisfaction questionnaires were designed to be collected for the SM arm only. The study enrolled control arm only prior to termination. The questionnaires were not collected, and no outcome measure analyses were performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires</title>
        <description>Number of clinicians &quot;very familiar&quot; and &quot;somewhat familiar&quot; with AHA guidelines was reported. The questionnaire was administered to all clinicians (e.g. ED physicians, nurses, critical care nurses, intensivists, and hospitalists) involved in the care of study participants at each hospital; it was not administered to study subjects.</description>
        <time_frame>Baseline to end of hospital stay (or up to 30 days post enrollment)</time_frame>
        <population>All clinicians (e.g. ED physicians, nurses, critical care nurses) involved in the care of study participants at each hospital (not study subjects.) The study was prematurely terminated; no conclusion should be drawn from the reported data. The data for SM Arm were not collected, and no outcome measure analyses were performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Telemetry Monitoring (TM) Arm</title>
            <description>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.&#xD;
Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.</description>
          </group>
          <group group_id="O2">
            <title>Surveillance Monitoring (SM) Arm</title>
            <description>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.&#xD;
Vital Sync IM &amp; VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) &amp; Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires</title>
          <description>Number of clinicians &quot;very familiar&quot; and &quot;somewhat familiar&quot; with AHA guidelines was reported. The questionnaire was administered to all clinicians (e.g. ED physicians, nurses, critical care nurses, intensivists, and hospitalists) involved in the care of study participants at each hospital; it was not administered to study subjects.</description>
          <population>All clinicians (e.g. ED physicians, nurses, critical care nurses) involved in the care of study participants at each hospital (not study subjects.) The study was prematurely terminated; no conclusion should be drawn from the reported data. The data for SM Arm were not collected, and no outcome measure analyses were performed.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="259"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The recording of adverse events for all enrolled subjects began after the telemetry devices were attached and ended with the subject completing study enrollment. Completion is defined by when a subject is discharged from the hospital, completes 30 day (± 2 days) enrollment period, or if the subject is withdrawn from the study for any reason.</time_frame>
      <desc>Only the following adverse events were collected for this study:&#xD;
Any adverse events noting mild or moderate physiological deterioration&#xD;
Any adverse event whose relationship to the study device is: possible, probable, definite, or unknown/ impossible to determine, regardless of what the event may be.&#xD;
All serious adverse event, of any relationship, meeting the protocol definitio</desc>
      <group_list>
        <group group_id="E1">
          <title>Telemetry Monitoring Arm</title>
          <description>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.&#xD;
Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.</description>
        </group>
        <group group_id="E2">
          <title>Surveillance Monitoring Arm</title>
          <description>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.&#xD;
Vital Sync IM &amp; VPMP (Surveillance Monitoring): The Vital Sync™ Informatics Manager (IM) &amp; Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>WORSENING ANEMIA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>CARDIAC ARREST</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>NEW ONSET ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>NEW ONSET ATRIAL FIBRILLATION/FLUTTER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>NON ST ELEVATION MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>NON STEMI</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>NON SUSTAINED VENTRICULAR TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>SUPRAVENTRICULAR TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>SYMPTOMATIC BRADYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING CONGESTIVE HEART FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING SINUS BRADYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING SINUS TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>GASTROINTESTINAL HEMORRHAGE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING GASTROINTESTINAL BLEED</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FACIAL EDEMA (CONCERN FOR ALLERGIC REACTION VS. ATYPICAL ANGIOEDEMA)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>WORSENING AV FISTULA INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING SEVERE SEPSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>WORSENING QT PROLONGATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERGLYCEMIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>HYPOGLYCEMIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>HYPOKALEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>RECURRENT HYPOGLYCEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>UNRESPONSIVENESS/HYPOGLYCEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING DIABETIC KETOACIDOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING HYERKALEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING HYPERGLYCEMIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING HYPERKALEMIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING HYPOKALEMIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING HYPONATREMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING METABOLIC ACIDOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>APHASIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>EXPRESSIVE APHASIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>LETHARGY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>AGITATED DELIRIUM</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>ALTERED MENTAL STATUS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>GROSS HEMATURIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ASPIRATION PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>HYPERCAPNIC RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>HYPERCARBIC RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>HYPOXEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>RESPIRATORY ARREST</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>TRANSFUSION-INDUCED PULMONARY EDEMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>UNRESPONSIVENESS/RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING COPD EXACERBATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HEMORRHAGIC SHOCK (GI BLEED SOURCE)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>WORSENING HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>VENTRICULAR TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CHEST PAIN</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>WORSENING LETHARGY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>AGITATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>INCREASED ALTERED MENTAL STATUS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="206"/>
                <counts group_id="E2" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This study was terminated early, no conclusions should be drawn from the data.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Anne Kinney</name_or_title>
      <organization>Medtronic</organization>
      <phone>+1-303-876-8904</phone>
      <email>anne.r.kinney@medtronic.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03039738
org study id: COVMOPO0561
nct id: NCT03039738
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of the study is to evaluate the impact of surveillance monitoring versus
      telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative
      outcomes.
This will be single-center, prospective, pilot, pre/post implementation study to collect
      post-market data on hospitalized subjects monitored via telemetry and surveillance monitoring
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Hospital Length of Stay (LOS) as Assessed by Review of Medical Records
time frame: Baseline to end of hospital stay (or up to 30 day post enrollment)
description: LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms.
measure: Associated Health Care Costs (HCC) as Determined by Review of Billing Records
time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
description: Health Care Costs will be determined by comparing HCC between the surveillance monitoring and telemetry monitoring arms
measure: Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records
time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
description: Hospital Unit Transfers (HUT) will be determined by comparing the number of hospital unit transfers between monitoring arms.
measure: Length of Stay (LOS) in the ICU as Determined by Review of Medical Records
time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
description: Length of Stay in the ICU will be determined by comparing numbers between monitoring arms.
measure: Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records
time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
description: CI include Rapid Response Team calls and Code Blue Activations. The Number of Clinical Interventions will be determined by comparing numbers between monitoring arms.
measure: Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only
time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
description: Time of Rapid Response Team (RRT) will be determined by comparing the number of RRT interventions between monitoring arms (only for surveillance monitoring arm)
measure: Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires
time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
description: Clinical Team and Patient Satisfaction will be determined by comparing the Qualitative Questionnaire response between monitoring arms.
measure: Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires
time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
description: Number of clinicians "very familiar" and "somewhat familiar" with AHA guidelines was reported. The questionnaire was administered to all clinicians (e.g. ED physicians, nurses, critical care nurses, intensivists, and hospitalists) involved in the care of study participants at each hospital; it was not administered to study subjects.
arm group label: Telemetry Monitoring Arm
arm group type: Active Comparator
description: The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.
arm group label: Surveillance Monitoring Arm
arm group type: Experimental
description: Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.
intervention type: Device
intervention name: Vital Sync IM & VPMP (Surveillance Monitoring)
description: The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.
arm group label: Surveillance Monitoring Arm
intervention type: Device
intervention name: Telemetry Monitoring
description: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.
arm group label: Telemetry Monitoring Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stacey House, MD, PhD
role: Principal Investigator
affiliation: Washington University in Saint Louis
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was terminated early, no conclusions should be drawn from the data.
point of contact: 