<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/NCT02209870</url>
  </required_header>
  <id_info>
    <org_study_id>201106044RC</org_study_id>
    <nct_id>NCT02209870</nct_id>
  </id_info>
  <brief_title>The Impact of Resuscitation Quality of CPR Team by Implantation of Electronic Checklist and Alarming System Through Video-recording Analyses</brief_title>
  <official_title>The Impact of Resuscitation Quality of CPR Team by Implantation of Electronic Checklist and Alarming System Through Video-recording Analyses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The quality of cardiopulmonary resuscitation (CPR) has been identified as an important&#xD;
      determinants for patient survival, yet many studies revealed poor CPR guidelines compliance&#xD;
      in real-life practice for both health care providers and lay persons. Common shortcomings&#xD;
      identified include an insufficient number of chest compression, too rapid lung inflations,&#xD;
      and too much hands-off time. The poor quality of CPR is associated with lower survival rate.&#xD;
      Besides, some other problems could be found during resuscitation, such as prolonged&#xD;
      intubation time, delayed first shock delivery or unsteady drug delivery interval. These&#xD;
      problems can't be blamed on the only person but the teamwork. Certain measurements could&#xD;
      improve the performance of the resuscitation team, such as audio prompt or checklist.&#xD;
&#xD;
      Methods proposed and improvised to improve the quality of CPR have included CPR assisted&#xD;
      devices, automatic driven devices or audio prompt system. However, some of these methods are&#xD;
      hardly incorporate with the original resuscitation process since it could be an extra&#xD;
      workload. Therefore, the investigators try to provide an digitized checklist combined with&#xD;
      visual and audio alarming system, which could not only minimize the workload of chart&#xD;
      recording but also remind the team to perform essential procedures in time.&#xD;
&#xD;
      Information gained from a video-recording evaluation system had been employed to improve the&#xD;
      resuscitation skills. The improvement of resuscitation quality also could be found through&#xD;
      video-recording after certain intervention. It can also avoid the interference of the&#xD;
      resuscitation and find out other harmful factors to CPR quality.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2011</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</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>return of spontaneous circulation</measure>
    <time_frame>60 minutes</time_frame>
    <description>return of spontaneous circulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical skill of CPR team</measure>
    <time_frame>30 minutes</time_frame>
    <description>including time to first shockable rhythm, no-flow time, frequency of chest compression, successful rate of rhythm conversion, Time to first shock</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-technical skill of CPR team</measure>
    <time_frame>30 minutes</time_frame>
    <description>Team structure and leadership, situation monitoring, workload management, communication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>survival for 2 hours</measure>
    <time_frame>2 hours</time_frame>
    <description>maintained spontaneous circulation for up to 2 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>survival to admission</measure>
    <time_frame>1 day</time_frame>
    <description>Survival to admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival to discharge</measure>
    <time_frame>60 days</time_frame>
    <description>Survival to discharge from hospital</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cardiopulmonary Arrest</condition>
  <arm_group>
    <arm_group_label>E-checklist group</arm_group_label>
    <description>The patients after CPR team using E-checklist system</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>E-checklist Group</intervention_name>
    <description>The patient group after E-checklist system deployed</description>
    <arm_group_label>E-checklist group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Emergency Department patient Out-of-Hospital cardiac arrest patient receive CPR in NTUH&#xD;
        Emergency Department Age &gt; 18 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Out-of-Hospital cardiac arrest patient present to NTUH ED&#xD;
&#xD;
          -  Age &gt; 18 years old&#xD;
&#xD;
          -  E-checklist system applied&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  E-Checklist system not applied&#xD;
&#xD;
          -  Video not been recorded&#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>Hui-Chih Wang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>May 31, 2013</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>April 1, 2015</last_update_submitted>
  <last_update_submitted_qc>April 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiopulmonary resuscitation</keyword>
  <keyword>Teamwork</keyword>
  <keyword>electronic checklist</keyword>
  <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/NCT02209870
org study id: 201106044RC
nct id: NCT02209870
lead sponsor: 
has dmc: No
The quality of cardiopulmonary resuscitation (CPR) has been identified as an important
      determinants for patient survival, yet many studies revealed poor CPR guidelines compliance
      in real-life practice for both health care providers and lay persons. Common shortcomings
      identified include an insufficient number of chest compression, too rapid lung inflations,
      and too much hands-off time. The poor quality of CPR is associated with lower survival rate.
      Besides, some other problems could be found during resuscitation, such as prolonged
      intubation time, delayed first shock delivery or unsteady drug delivery interval. These
      problems can't be blamed on the only person but the teamwork. Certain measurements could
      improve the performance of the resuscitation team, such as audio prompt or checklist.

      Methods proposed and improvised to improve the quality of CPR have included CPR assisted
      devices, automatic driven devices or audio prompt system. However, some of these methods are
      hardly incorporate with the original resuscitation process since it could be an extra
      workload. Therefore, the investigators try to provide an digitized checklist combined with
      visual and audio alarming system, which could not only minimize the workload of chart
      recording but also remind the team to perform essential procedures in time.

      Information gained from a video-recording evaluation system had been employed to improve the
      resuscitation skills. The improvement of resuscitation quality also could be found through
      video-recording after certain intervention. It can also avoid the interference of the
      resuscitation and find out other harmful factors to CPR quality.
observational model: Cohort
time perspective: Prospective
measure: return of spontaneous circulation
time frame: 60 minutes
description: return of spontaneous circulation
measure: Technical skill of CPR team
time frame: 30 minutes
description: including time to first shockable rhythm, no-flow time, frequency of chest compression, successful rate of rhythm conversion, Time to first shock
measure: Non-technical skill of CPR team
time frame: 30 minutes
description: Team structure and leadership, situation monitoring, workload management, communication
measure: survival for 2 hours
time frame: 2 hours
description: maintained spontaneous circulation for up to 2 hours
measure: survival to admission
time frame: 1 day
description: Survival to admission
measure: Survival to discharge
time frame: 60 days
description: Survival to discharge from hospital
arm group label: E-checklist group
description: The patients after CPR team using E-checklist system
intervention type: Behavioral
intervention name: E-checklist Group
description: The patient group after E-checklist system deployed
arm group label: E-checklist group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hui-Chih Wang, MD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Heart Arrest