<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/NCT02248623</url>
  </required_header>
  <id_info>
    <org_study_id>ConsCIOUS</org_study_id>
    <nct_id>NCT02248623</nct_id>
  </id_info>
  <brief_title>Intraoperative Anaesthesia Awareness Following Induction of Anaesthesia</brief_title>
  <acronym>ConsCIOUS</acronym>
  <official_title>An International Multi-Centre Cohort Study of the Incidence of Anaesthesia Awareness Following Laryngoscopy and Intubation: The CONSciousness, Connectedness and IntraOperative Unresponsiveness Study (ConsCIOUS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Groningen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centre Hospitalier Régional de la Citadelle</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RWTH Aachen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Auckland, New Zealand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Witten/Herdecke</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College London Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A primary aim of anaesthesia is to prevent awareness of surgery; ablation of the experience&#xD;
      of surgery is the most secure way to prevent awareness with recall. Fortunately the incidence&#xD;
      of awareness with recall (the patient can spontaneously remember the intraoperative event) is&#xD;
      very rare (0.1-0.2%). However the investigators systematic review suggests that consciousness&#xD;
      of intraoperative events may occur in approximately 37% of patients in experimental studies&#xD;
      (as identified by the validated clinical procedure the isolated forearm test that does not&#xD;
      require postoperative recall of the event). In this international cohort study, recruiting a&#xD;
      minimum sample of 200 patients, the investigators will investigate the incidence of&#xD;
      anaesthesia awareness (as identified by the isolated forearm test) following the induction of&#xD;
      anaesthesia and before surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of isolated forearm test responsiveness following laryngoscopy and intubation</measure>
    <time_frame>The test will occur within one minute of securing the airway (laryngoscopy and intubation).</time_frame>
    <description>Following induction of anaesthesia, and securing the airway (laryngoscopy and intubation) the patient will be asked to squeeze the anaesthetist's hand as a surrogate of awareness under anaesthesia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of isolated forearm test responsiveness before laryngoscopy and intubation</measure>
    <time_frame>The test will occur in the minute prior to securing the airway (laryngoscopy and intubation).</time_frame>
    <description>Following induction of anaesthesia, and prior to securing the airway (before laryngoscopy and intubation) if safe to do so, the patient will be asked to squeeze the anaesthetist's hand as a surrogate of anaesthesia awareness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of anaesthesia awareness with recall</measure>
    <time_frame>Within 24 hours of the operation</time_frame>
    <description>After the operation and emergence from anaesthesia, and within 24 hours of the operation, the patient will be asked, using the structured Modified Brice questionnaire, about recall of intraoperative events (anaesthesia awareness).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction questionnaire</measure>
    <time_frame>Within 24 hours of the operation and emergence from anaesthesia</time_frame>
    <description>Within 24 hours of the operation and emergence from anaesthesia, the patient will be asked to complete a patient satisfaction questionnaire rating the anaesthetic care they received. This will cover the preoperative information they were given, their emergence from anaesthesia, their pain control, experience of nausea and vomiting and their general experience. They will be asked to rate their care from four options: very satisfied, satisfied, dissatisfied and very dissatisfied.</description>
  </secondary_outcome>
  <enrollment type="Actual">260</enrollment>
  <condition>Anaesthesia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients undergoing anaesthesia requiring intubation and layngoscopy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients clinically requiring intubation will be included in this cohort.&#xD;
&#xD;
          -  Patients must be able to follow the isolated forearm technique commands when awake and&#xD;
             prior to their operation will be included in this cohort.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to isolated forearm technique test such as unable to have tourniquet&#xD;
             on arm for the isolated forearm technique (e.g. lymphedema or operative site).&#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>Robert D Sanders, MBBS PhD FRCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Auckland</name>
      <address>
        <city>Hamilton</city>
        <state>Waikato</state>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>April 4, 2016</last_update_submitted>
  <last_update_submitted_qc>April 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anaesthesia</keyword>
  <keyword>Isolated forearm test</keyword>
  <keyword>Responsiveness</keyword>
  <keyword>Laryngoscopy</keyword>
  <keyword>Intubation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intraoperative Awareness</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/NCT02248623
org study id: ConsCIOUS
nct id: NCT02248623
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
A primary aim of anaesthesia is to prevent awareness of surgery; ablation of the experience
      of surgery is the most secure way to prevent awareness with recall. Fortunately the incidence
      of awareness with recall (the patient can spontaneously remember the intraoperative event) is
      very rare (0.1-0.2%). However the investigators systematic review suggests that consciousness
      of intraoperative events may occur in approximately 37% of patients in experimental studies
      (as identified by the validated clinical procedure the isolated forearm test that does not
      require postoperative recall of the event). In this international cohort study, recruiting a
      minimum sample of 200 patients, the investigators will investigate the incidence of
      anaesthesia awareness (as identified by the isolated forearm test) following the induction of
      anaesthesia and before surgery.
observational model: Cohort
time perspective: Prospective
measure: Incidence of isolated forearm test responsiveness following laryngoscopy and intubation
time frame: The test will occur within one minute of securing the airway (laryngoscopy and intubation).
description: Following induction of anaesthesia, and securing the airway (laryngoscopy and intubation) the patient will be asked to squeeze the anaesthetist's hand as a surrogate of awareness under anaesthesia.
measure: Incidence of isolated forearm test responsiveness before laryngoscopy and intubation
time frame: The test will occur in the minute prior to securing the airway (laryngoscopy and intubation).
description: Following induction of anaesthesia, and prior to securing the airway (before laryngoscopy and intubation) if safe to do so, the patient will be asked to squeeze the anaesthetist's hand as a surrogate of anaesthesia awareness.
measure: Incidence of anaesthesia awareness with recall
time frame: Within 24 hours of the operation
description: After the operation and emergence from anaesthesia, and within 24 hours of the operation, the patient will be asked, using the structured Modified Brice questionnaire, about recall of intraoperative events (anaesthesia awareness).
measure: Patient satisfaction questionnaire
time frame: Within 24 hours of the operation and emergence from anaesthesia
description: Within 24 hours of the operation and emergence from anaesthesia, the patient will be asked to complete a patient satisfaction questionnaire rating the anaesthetic care they received. This will cover the preoperative information they were given, their emergence from anaesthesia, their pain control, experience of nausea and vomiting and their general experience. They will be asked to rate their care from four options: very satisfied, satisfied, dissatisfied and very dissatisfied.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert D Sanders, MBBS PhD FRCA
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
facility: 
facility: 
country: New Zealand
country: United States
responsible party type: Sponsor
mesh term: Intraoperative Awareness