<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/NCT02985970</url>
  </required_header>
  <id_info>
    <org_study_id>RSI 2016CZ</org_study_id>
    <nct_id>NCT02985970</nct_id>
  </id_info>
  <brief_title>Rapid Sequence Induction Czech Republic: Survey</brief_title>
  <acronym>RSICZ</acronym>
  <official_title>Rapid Sequence Induction in Czech Republic: Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brno University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brno University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rapid sequence induction (RSI) is a common part of routine anesthesiology practice.However&#xD;
      several steps of RSI are not based on evidence based data (EBM) and are considered&#xD;
      controversial. In an electronic evaluation form that will be send to Czech society of&#xD;
      anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4&#xD;
      clinical scenarios in which RSI should be used. In the questionnaire the participants have to&#xD;
      choose RSI or no and they have to describe all the next steps on anesthesia induction process&#xD;
      in each single clinical scenario.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rapid sequence induction (RSI) is a common part of routine anesthesiology practice.However&#xD;
      several steps of RSI are not based on evidence based data (EBM) and are considered&#xD;
      controversial. In an electronic evaluation form that will be send to Czech society of&#xD;
      anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4&#xD;
      clinical scenarios in which RSI should be used. In the questionnaire the participants have to&#xD;
      choose RSI or no and they have to describe all the next steps on anesthesia induction process&#xD;
      in each single clinical scenario.&#xD;
&#xD;
        -  1st. scenario - adult patient with acute abdomen in the OR to be anesthetized&#xD;
&#xD;
        -  2nd. scenario - 4 years old child with acute abdomen in the OR scheduled for an acute&#xD;
           surgery&#xD;
&#xD;
        -  3rd. scenario - pregnant women scheduled for an elective caesarean section in the OR&#xD;
&#xD;
        -  4th. scenario - geriatric patient with hiatal hernia scheduled for an elective&#xD;
           laparoscopic cholecystectomy.&#xD;
&#xD;
      In each scenario the several steps of the RSI sequence has to be answered:&#xD;
&#xD;
      Is RSI indicated? Y N&#xD;
&#xD;
      Peripheral vein line before induction? Y N&#xD;
&#xD;
      Nasogastric tube before/after induction or without?&#xD;
&#xD;
      Patients position: neutral, head-up, head-down?&#xD;
&#xD;
      Preoxygenation - 3/5minutes, breaths, (CPAP)/Positive end-expiratory pressure (PEEP)?&#xD;
&#xD;
      Sellick manoeuver? Y N&#xD;
&#xD;
      Drugs for induction (order with the number in the row) - propofol, etomidate, ketamine,&#xD;
      thiopental, midazolam, suxamethonium, rocuronium, cisatracurium, atracurium, vecuronium&#xD;
&#xD;
      Manual hand-bag ventilation after induction: with limited pressure/contraindicated&#xD;
&#xD;
      Airway: tracheal tube with the cuff/without cuff/laryngeal mask&#xD;
&#xD;
      Comments&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>RSI practice in Czech Republic - questionnaire</measure>
    <time_frame>one month</time_frame>
    <description>Evaluation of the clinical practice of the RSI in Czech Republic</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">164</enrollment>
  <condition>Rapid Sequence Induction</condition>
  <arm_group>
    <arm_group_label>ČSARIM - questionnaire</arm_group_label>
    <description>Members of Czech society of anesthesiology, resuscitation and intensive care will obtain the questionnaire</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>The questionnaire will be send to all members of ČSARIM with the selected 4 controversial clinical scenarios in which the RSI should be used</description>
    <arm_group_label>ČSARIM - questionnaire</arm_group_label>
    <other_name>survey</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Anesthesiologists - members of the ČSARIM and www.akutne.cz&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all members of ČSARIM and www.akutne.cz&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not members of ČSARIM and www.akutne.cz&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Petr Štourač, doc.MD.Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital Brno</affiliation>
  </overall_official>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>April 21, 2017</last_update_submitted>
  <last_update_submitted_qc>April 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brno University Hospital</investigator_affiliation>
    <investigator_full_name>Petr Štourač, MD</investigator_full_name>
    <investigator_title>Doc.MD.Ph.D</investigator_title>
  </responsible_party>
  <keyword>crush induction, RSI</keyword>
  <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/NCT02985970
org study id: RSI 2016CZ
nct id: NCT02985970
lead sponsor: 
has dmc: No
Rapid sequence induction (RSI) is a common part of routine anesthesiology practice.However
      several steps of RSI are not based on evidence based data (EBM) and are considered
      controversial. In an electronic evaluation form that will be send to Czech society of
      anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4
      clinical scenarios in which RSI should be used. In the questionnaire the participants have to
      choose RSI or no and they have to describe all the next steps on anesthesia induction process
      in each single clinical scenario.
Rapid sequence induction (RSI) is a common part of routine anesthesiology practice.However
      several steps of RSI are not based on evidence based data (EBM) and are considered
      controversial. In an electronic evaluation form that will be send to Czech society of
      anesthesiology, resuscitation and intensive care (ČSARIM) members, the investigators bring 4
      clinical scenarios in which RSI should be used. In the questionnaire the participants have to
      choose RSI or no and they have to describe all the next steps on anesthesia induction process
      in each single clinical scenario.

        -  1st. scenario - adult patient with acute abdomen in the OR to be anesthetized

        -  2nd. scenario - 4 years old child with acute abdomen in the OR scheduled for an acute
           surgery

        -  3rd. scenario - pregnant women scheduled for an elective caesarean section in the OR

        -  4th. scenario - geriatric patient with hiatal hernia scheduled for an elective
           laparoscopic cholecystectomy.

      In each scenario the several steps of the RSI sequence has to be answered:

      Is RSI indicated? Y N

      Peripheral vein line before induction? Y N

      Nasogastric tube before/after induction or without?

      Patients position: neutral, head-up, head-down?

      Preoxygenation - 3/5minutes, breaths, (CPAP)/Positive end-expiratory pressure (PEEP)?

      Sellick manoeuver? Y N

      Drugs for induction (order with the number in the row) - propofol, etomidate, ketamine,
      thiopental, midazolam, suxamethonium, rocuronium, cisatracurium, atracurium, vecuronium

      Manual hand-bag ventilation after induction: with limited pressure/contraindicated

      Airway: tracheal tube with the cuff/without cuff/laryngeal mask

      Comments
observational model: Other
time perspective: Prospective
measure: RSI practice in Czech Republic - questionnaire
time frame: one month
description: Evaluation of the clinical practice of the RSI in Czech Republic
arm group label: ČSARIM - questionnaire
description: Members of Czech society of anesthesiology, resuscitation and intensive care will obtain the questionnaire
intervention type: Other
intervention name: questionnaire
description: The questionnaire will be send to all members of ČSARIM with the selected 4 controversial clinical scenarios in which the RSI should be used
arm group label: ČSARIM - questionnaire
other name: survey
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Petr Štourač, doc.MD.Ph.D
role: Study Chair
affiliation: University Hospital Brno
responsible party type: Principal Investigator
investigator affiliation: Brno University Hospital
investigator full name: Petr Štourač, MD
investigator title: Doc.MD.Ph.D
sharing ipd: Undecided