<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/NCT04507581</url>
  </required_header>
  <id_info>
    <org_study_id>2020-01421</org_study_id>
    <nct_id>NCT04507581</nct_id>
  </id_info>
  <brief_title>Evaluation of Atelectasis Formation With Electrical Impedance Tomography During Anesthesia for MRI in Children</brief_title>
  <acronym>ATLANTIS</acronym>
  <official_title>Evaluation of Atelectasis Formation With Electrical Impedance Tomography During Anesthesia for MRI in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      This study investigates under controlled conditions the variation of poorly ventilated lung&#xD;
      units (silent spaces) in children between 1 and 6 years of age measured by electrical&#xD;
      impedance tomography during intravenous anaesthesia in a day-hospital setting and before&#xD;
      discharge to help further raise safety standards in paediatric anaesthesia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible, children, with parental written informed consent, scheduled for a cerebral magnetic&#xD;
      resonance image (MRI) will receive an intravenous anaesthesia using a Propofol infusion of 10&#xD;
      mg/kg/h. At the Bern Children's Hospital all children will be premedicated with Midazolam&#xD;
      rectal/oral 0.5 mg/kg or Dexmedetomidine nasal 2 mcg/kg 20 minutes before the beginning of&#xD;
      the procedure Eligible children will be prepared for procedure according to the local SOPs of&#xD;
      the paediatric anaesthesia departments. Mandatory monitoring will consist of: SpO2, HR, NIBP.&#xD;
      An iv-line for drugs injection will be placed.&#xD;
&#xD;
      Induction of anaesthesia: after iv-line placement a bolus of Propofol of 2 mg/kg followed by&#xD;
      a continuous infusion of 10 mg/kg/h will be applied. Administration of low-flow oxygen for&#xD;
      all children (0.3 l/kg/min) via Microstream® Smart CapnoLine® paediatric cannula (Philips&#xD;
      Healthcare, Amsterdam, Netherlands). This cannula allows to measure the etCO2.&#xD;
&#xD;
      In case of extremely agitated child an inhalative induction may be performed. This technique&#xD;
      represent the actual standard of care and is not associated with increased risks because of&#xD;
      the study.&#xD;
&#xD;
      Before induction of the anaesthesia, before the radiological procedure when the induction is&#xD;
      terminated, after the termination of the radiological procedure, before transport to the Post&#xD;
      anaesthesia Care Unite (PACU), and before the discharge from the PACU after 2 hours of&#xD;
      monitoring ventilation distribution changes by thoracic electrical impedance tomography are&#xD;
      measured (each measurement will last 1 min).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 30, 2020</start_date>
  <completion_date type="Actual">October 19, 2021</completion_date>
  <primary_completion_date type="Actual">October 19, 2021</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>Changes in poorly ventilated lung areas at 2 Hours after intervention</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes in poorly ventilated lung areas (silent spaces) by using electrical impedance tomography (EIT) 2 hours after the end of anaesthesia before discharge at home, which will help quantify the degree of atelectasis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2 min after Anesthesia induction</measure>
    <time_frame>2 minutes after the end of anaesthesia induction</time_frame>
    <description>Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT) 2 minutes after the end of induction, before the radiological procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>end of the radiological procedure.</measure>
    <time_frame>2 minutes after the end of radiological procedure</time_frame>
    <description>Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT) at the end of the radiological procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2 minutes after the end of anaesthesia</measure>
    <time_frame>2 minutes after the end of anaesthesia, before the transport in Post Anaesthesia Care Unit</time_frame>
    <description>Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT) 2 minutes after the end of anaesthesia, before the transport in PACU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of radiological procedure.</measure>
    <time_frame>minutes</time_frame>
    <description>Duration of radiological procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of anaesthesia</measure>
    <time_frame>minutes</time_frame>
    <description>Duration of anaesthesia</description>
  </secondary_outcome>
  <enrollment type="Actual">30</enrollment>
  <condition>Anesthesia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>electrical impedance tomography during anaesthesia</intervention_name>
    <description>Before induction of the anaesthesia, before the radiological procedure when the induction is terminated, after the termination of the radiological procedure, before transport to the Post anaesthesia Care Unite (PACU), and before the discharge from the PACU after 2 hours of monitoring ventilation distribution changes by thoracic electrical impedance tomography are measured (each measurement will last 1 min). For this, resulting potential differences are measured, and impedance distribution sampled at 30 Hz will be calculated by an automated linearized Newton-Raphson reconstruction algorithm (9). Relative change in poorly ventilated lung regions (silent spaces) and end-expiratory lung impedance (EELI) and measures of ventilation inhomogeneity such as the global inhomogeneity index will be calculated as described previously, using customised software (Matlab R2013a, The MathWorks, Nattick, Massachusetts, USA)(10-12).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will include paediatric patients undergoing radiological procedures requiring&#xD;
        intravenous anaesthesia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA physical status 1 to 3,&#xD;
&#xD;
          -  1 to 6 years of age with legal guardians providing written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria are necessity to intubate the child,&#xD;
&#xD;
          -  contraindication for propofol administration,&#xD;
&#xD;
          -  congenital heart or lung disease with oxygen&#xD;
&#xD;
          -  dependency and high aspiration risk (requiring rapid sequence induction intubation).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas H Riva, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Insel Gruppe AG, University Hospital Bern</investigator_affiliation>
    <investigator_full_name>Thomas Riva</investigator_full_name>
    <investigator_title>Dr.med</investigator_title>
  </responsible_party>
  <keyword>children</keyword>
  <keyword>electrical impedance tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Atelectasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04507581
org study id: 2020-01421
nct id: NCT04507581
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates under controlled conditions the variation of poorly ventilated lung
      units (silent spaces) in children between 1 and 6 years of age measured by electrical
      impedance tomography during intravenous anaesthesia in a day-hospital setting and before
      discharge to help further raise safety standards in paediatric anaesthesia
Eligible, children, with parental written informed consent, scheduled for a cerebral magnetic
      resonance image (MRI) will receive an intravenous anaesthesia using a Propofol infusion of 10
      mg/kg/h. At the Bern Children's Hospital all children will be premedicated with Midazolam
      rectal/oral 0.5 mg/kg or Dexmedetomidine nasal 2 mcg/kg 20 minutes before the beginning of
      the procedure Eligible children will be prepared for procedure according to the local SOPs of
      the paediatric anaesthesia departments. Mandatory monitoring will consist of: SpO2, HR, NIBP.
      An iv-line for drugs injection will be placed.

      Induction of anaesthesia: after iv-line placement a bolus of Propofol of 2 mg/kg followed by
      a continuous infusion of 10 mg/kg/h will be applied. Administration of low-flow oxygen for
      all children (0.3 l/kg/min) via Microstream® Smart CapnoLine® paediatric cannula (Philips
      Healthcare, Amsterdam, Netherlands). This cannula allows to measure the etCO2.

      In case of extremely agitated child an inhalative induction may be performed. This technique
      represent the actual standard of care and is not associated with increased risks because of
      the study.

      Before induction of the anaesthesia, before the radiological procedure when the induction is
      terminated, after the termination of the radiological procedure, before transport to the Post
      anaesthesia Care Unite (PACU), and before the discharge from the PACU after 2 hours of
      monitoring ventilation distribution changes by thoracic electrical impedance tomography are
      measured (each measurement will last 1 min).
observational model: Other
time perspective: Prospective
measure: Changes in poorly ventilated lung areas at 2 Hours after intervention
time frame: 2 hours
description: Changes in poorly ventilated lung areas (silent spaces) by using electrical impedance tomography (EIT) 2 hours after the end of anaesthesia before discharge at home, which will help quantify the degree of atelectasis
measure: 2 min after Anesthesia induction
time frame: 2 minutes after the end of anaesthesia induction
description: Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT) 2 minutes after the end of induction, before the radiological procedure.
measure: end of the radiological procedure.
time frame: 2 minutes after the end of radiological procedure
description: Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT) at the end of the radiological procedure
measure: 2 minutes after the end of anaesthesia
time frame: 2 minutes after the end of anaesthesia, before the transport in Post Anaesthesia Care Unit
description: Changes in silent spaces and end-expiratory lung impedance (EELI) by using electrical impedance tomography (EIT) 2 minutes after the end of anaesthesia, before the transport in PACU.
measure: Duration of radiological procedure.
time frame: minutes
description: Duration of radiological procedure.
measure: Duration of anaesthesia
time frame: minutes
description: Duration of anaesthesia
intervention type: Other
intervention name: electrical impedance tomography during anaesthesia
description: Before induction of the anaesthesia, before the radiological procedure when the induction is terminated, after the termination of the radiological procedure, before transport to the Post anaesthesia Care Unite (PACU), and before the discharge from the PACU after 2 hours of monitoring ventilation distribution changes by thoracic electrical impedance tomography are measured (each measurement will last 1 min). For this, resulting potential differences are measured, and impedance distribution sampled at 30 Hz will be calculated by an automated linearized Newton-Raphson reconstruction algorithm (9). Relative change in poorly ventilated lung regions (silent spaces) and end-expiratory lung impedance (EELI) and measures of ventilation inhomogeneity such as the global inhomogeneity index will be calculated as described previously, using customised software (Matlab R2013a, The MathWorks, Nattick, Massachusetts, USA)(10-12).
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas H Riva, MD
role: Principal Investigator
affiliation: University of Bern
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Insel Gruppe AG, University Hospital Bern
investigator full name: Thomas Riva
investigator title: Dr.med
mesh term: Pulmonary Atelectasis
mesh term: Anesthetics
sharing ipd: No