<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/NCT03253770</url>
  </required_header>
  <id_info>
    <org_study_id>SIMMAX2</org_study_id>
    <nct_id>NCT03253770</nct_id>
  </id_info>
  <brief_title>Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest.</brief_title>
  <acronym>SIMMAX2</acronym>
  <official_title>Use of a Hand-held Digital Cognitive Aid in Simulated Cardiac Arrest.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Claude Bernard University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Claude Bernard University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cardiac arrest is one of the most stressful situations to be managed. Our first study (MAX,&#xD;
      accepted for publication BJA) clearly showed that it could not be compared to other urgent&#xD;
      and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local&#xD;
      anesthetics, severe and symptomatic hyperkaliemia) whose management was significantly&#xD;
      improved with the help of a digital cognitive aid.&#xD;
&#xD;
      The present study exclusively deals with the management of cardiac arrest (recovery ward, or&#xD;
      in the delivery room.) with the second generation of our digital cognitive aid, and explores&#xD;
      new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand&#xD;
      of the leader.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &quot; Errare humanum est &quot;, to err is human. This Latin saying attributed to Seneca shows that&#xD;
      since the dawn of time, human beings are aware that managing complex situations will always&#xD;
      be an inexhaustible source of mistakes. This is particularly true in anesthesia and intensive&#xD;
      care in which situations are often complex and stressful, thus leading to mistakes or&#xD;
      inadequate management. Improvement might arise from the use of cognitive aids.&#xD;
&#xD;
      In a first study (MAX, accepted for publication BJA) the investigators designed a smartphone&#xD;
      application including 5 scenarios of anesthesia and intensive care crises (malignant&#xD;
      hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic&#xD;
      hyperkaliemia, ventricular fibrillation), designed to be used in the hand of the leader&#xD;
      managing the crises. Technical and non technical skills were improved in 4 out of 5&#xD;
      scenarios. Cardiac arrest (ventricular fibrillation) clearly happened to be a different&#xD;
      situation compared to other crises, and no improvement could be measured with our cognitive&#xD;
      aid.&#xD;
&#xD;
      The present study exclusively deals with the management of cardiac arrest (man in recovery&#xD;
      ward, pregnant woman in the delivery room) with the second generation of our digital&#xD;
      cognitive aid, and explores new insights on how to better manage cardiac arrest with a&#xD;
      digital cognitive aid in the hand of the leader.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">August 16, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Technical Performance as compared to a Reference Task List</measure>
    <time_frame>[ Time Frame: Time 0-30 min ]</time_frame>
    <description>Number of tasks successfully performed, rated on remote video review</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non technical skills performance</measure>
    <time_frame>[ Time Frame: Time 0-30 min ]</time_frame>
    <description>As measured by the Ottawa score, rated on remote video review</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Digital Cognitive Aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid in the hand of the leader during crises management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No digital aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No cognitive aid in the hand of the leader during crises management. Intervention : no cognitive aid in the hand of the leader during crises management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paper Cognitive Aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The paper cognitive aid is the document officially recommended to be used in case of crises by the French Society of Anaesthesia and Intensive Care.&#xD;
Intervention : paper cognitive aid in the hand of the leader during crises management.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SIMMAX2</intervention_name>
    <description>Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.</description>
    <arm_group_label>Digital Cognitive Aid</arm_group_label>
    <arm_group_label>No digital aid</arm_group_label>
    <arm_group_label>Paper Cognitive Aid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:•&#xD;
&#xD;
          -  Resident Physicians training in Anesthesia/Intensive care (same specialization in&#xD;
             France), year 1 to 5 (out of 5)&#xD;
&#xD;
          -  to be familiar with our simulation centre (at least passed once as a resident)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no experience in simulation training&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre Lyonnais d'Enseignement par la Simulation en Santé</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Claude Bernard University</investigator_affiliation>
    <investigator_full_name>CEJKA Jean-Christophe</investigator_full_name>
    <investigator_title>MD, PhD, MEng</investigator_title>
  </responsible_party>
  <keyword>Cognitive Aid</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03253770
org study id: SIMMAX2
nct id: NCT03253770
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiac arrest is one of the most stressful situations to be managed. Our first study (MAX,
      accepted for publication BJA) clearly showed that it could not be compared to other urgent
      and stressful situations (malignant hyperthermia, anaphylactic shock, acute toxicity of local
      anesthetics, severe and symptomatic hyperkaliemia) whose management was significantly
      improved with the help of a digital cognitive aid.

      The present study exclusively deals with the management of cardiac arrest (recovery ward, or
      in the delivery room.) with the second generation of our digital cognitive aid, and explores
      new insights on how to better manage cardiac arrest with a digital cognitive aid in the hand
      of the leader.
" Errare humanum est ", to err is human. This Latin saying attributed to Seneca shows that
      since the dawn of time, human beings are aware that managing complex situations will always
      be an inexhaustible source of mistakes. This is particularly true in anesthesia and intensive
      care in which situations are often complex and stressful, thus leading to mistakes or
      inadequate management. Improvement might arise from the use of cognitive aids.

      In a first study (MAX, accepted for publication BJA) the investigators designed a smartphone
      application including 5 scenarios of anesthesia and intensive care crises (malignant
      hyperthermia, anaphylactic shock, acute toxicity of local anesthetics, severe and symptomatic
      hyperkaliemia, ventricular fibrillation), designed to be used in the hand of the leader
      managing the crises. Technical and non technical skills were improved in 4 out of 5
      scenarios. Cardiac arrest (ventricular fibrillation) clearly happened to be a different
      situation compared to other crises, and no improvement could be measured with our cognitive
      aid.

      The present study exclusively deals with the management of cardiac arrest (man in recovery
      ward, pregnant woman in the delivery room) with the second generation of our digital
      cognitive aid, and explores new insights on how to better manage cardiac arrest with a
      digital cognitive aid in the hand of the leader.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Technical Performance as compared to a Reference Task List
time frame: [ Time Frame: Time 0-30 min ]
description: Number of tasks successfully performed, rated on remote video review
measure: Non technical skills performance
time frame: [ Time Frame: Time 0-30 min ]
description: As measured by the Ottawa score, rated on remote video review
arm group label: Digital Cognitive Aid
arm group type: Experimental
description: The digital cognitive aid is designed as a smartphone app. Intervention : cognitive aid in the hand of the leader during crises management.
arm group label: No digital aid
arm group type: Experimental
description: No cognitive aid in the hand of the leader during crises management. Intervention : no cognitive aid in the hand of the leader during crises management.
arm group label: Paper Cognitive Aid
arm group type: Experimental
description: The paper cognitive aid is the document officially recommended to be used in case of crises by the French Society of Anaesthesia and Intensive Care.
Intervention : paper cognitive aid in the hand of the leader during crises management.
intervention type: Device
intervention name: SIMMAX2
description: Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.
arm group label: Digital Cognitive Aid
arm group label: No digital aid
arm group label: Paper Cognitive Aid
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Claude Bernard University
investigator full name: CEJKA Jean-Christophe
investigator title: MD, PhD, MEng
mesh term: Heart Arrest
sharing ipd: Undecided