<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/NCT02986581</url>
  </required_header>
  <id_info>
    <org_study_id>SAFER_20161101</org_study_id>
    <nct_id>NCT02986581</nct_id>
  </id_info>
  <brief_title>Prospective Cohort Study of Rapid Response Team</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to collect data of rapid response team activated patients&#xD;
      prospectively&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      acutely deteriorating patients including sudden cardiac arrest in general ward who are&#xD;
      monitored and intervened by rapid response team&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2026</completion_date>
  <primary_completion_date type="Anticipated">November 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>mortality or ICU admission of rapid response team activated patient</measure>
    <time_frame>an average of 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of preventable cardiac arrest</measure>
    <time_frame>an average of 1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of triggerring criteria(1) for activation of rapid response team</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>SBP &lt;90mmHg(mABP 60mmHg) +- clinically correlated symptom or sign</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of triggerring criteria(2) for activation of rapid response team</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>HR: &lt;50/min or &gt;140/min or symptomatic arrythmia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of triggerring criteria(3) for activation of rapid response team</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>RR: &lt;10/min or &gt;30/min or stridor(sign of airway obstruction) or accessary muscle use</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of triggerring criteria(4) for activation of rapid response team</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>Oxygenation: SaO2 &lt;90% in room air or FM 8L/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of triggerring criteria(5) for activation of rapid response team</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>Metabolic acidosis: Lactic acid&lt;2.5 , TCO2 &lt;15</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of triggerring criteria(6) for activation of rapid response team</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>ABGA abnormality : PaCO2&gt;50 or pH&lt;7.3 or PaO2&lt;60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of triggerring criteria(7) for activation of rapid response team</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>ABGA abnormality : PaCO2&gt;50 or pH&lt;7.3 or PaO2&lt;60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of triggerring criteria(8) for activation of rapid response team</measure>
    <time_frame>an average of 1 year</time_frame>
    <description>Any serious concern about overall deterioration detected by doctor, nurse and caregiver at bedside</description>
  </secondary_outcome>
  <enrollment type="Anticipated">79800</enrollment>
  <condition>Hospital Medical Emergency Team</condition>
  <condition>Medicine, Emergency</condition>
  <condition>Hospital Rapid Response Team</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to general ward in Seoul National University Bundang Hospital and&#xD;
        monitored by in-hospital rapid response system.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients admitted to general ward in Seoul National University Bundang Hospital and&#xD;
        monitored by in-hospital rapid response system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients admitted to pediatric wards&#xD;
&#xD;
          -  patients in emergency room, intensive care unit, and operating room&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yeon Joo Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yeon Joo Lee, MD</last_name>
    <email>yjlee1117@snubh.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yeon Joo Lee, MD</last_name>
      <phone>+82317877082</phone>
      <email>yjlee1117@snubh.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>November 4, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>June 27, 2021</last_update_submitted>
  <last_update_submitted_qc>June 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2021</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>Emergencies</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/NCT02986581
org study id: SAFER_20161101
nct id: NCT02986581
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to collect data of rapid response team activated patients
      prospectively
acutely deteriorating patients including sudden cardiac arrest in general ward who are
      monitored and intervened by rapid response team
observational model: Cohort
time perspective: Prospective
measure: mortality or ICU admission of rapid response team activated patient
time frame: an average of 1 year
measure: incidence of preventable cardiac arrest
time frame: an average of 1 year
measure: Frequency of triggerring criteria(1) for activation of rapid response team
time frame: an average of 1 year
description: SBP <90mmHg(mABP 60mmHg) +- clinically correlated symptom or sign
measure: Frequency of triggerring criteria(2) for activation of rapid response team
time frame: an average of 1 year
description: HR: <50/min or >140/min or symptomatic arrythmia
measure: Frequency of triggerring criteria(3) for activation of rapid response team
time frame: an average of 1 year
description: RR: <10/min or >30/min or stridor(sign of airway obstruction) or accessary muscle use
measure: Frequency of triggerring criteria(4) for activation of rapid response team
time frame: an average of 1 year
description: Oxygenation: SaO2 <90% in room air or FM 8L/min
measure: Frequency of triggerring criteria(5) for activation of rapid response team
time frame: an average of 1 year
description: Metabolic acidosis: Lactic acid<2.5 , TCO2 <15
measure: Frequency of triggerring criteria(6) for activation of rapid response team
time frame: an average of 1 year
description: ABGA abnormality : PaCO2>50 or pH<7.3 or PaO2<60
measure: Frequency of triggerring criteria(7) for activation of rapid response team
time frame: an average of 1 year
description: ABGA abnormality : PaCO2>50 or pH<7.3 or PaO2<60
measure: Frequency of triggerring criteria(8) for activation of rapid response team
time frame: an average of 1 year
description: Any serious concern about overall deterioration detected by doctor, nurse and caregiver at bedside
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Yeon Joo Lee, MD
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: Yeon Joo Lee, MD
email: yjlee1117@snubh.org
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Emergencies