<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/NCT03812354</url>
  </required_header>
  <id_info>
    <org_study_id>Riva2018</org_study_id>
    <nct_id>NCT03812354</nct_id>
  </id_info>
  <brief_title>THRIVE in Children at Different Flow Rates</brief_title>
  <official_title>THRIVE (Transnasal Humidified Rapid Insufflation Ventilatory Exchange) in Children at Different Flow Rates</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 circumstances the concept of THRIVE to improve the&#xD;
      ventilation and the carbon dioxide elimination, to prolong the apnoea time without&#xD;
      deoxygenation and to improve safety of airway management in pediatric patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible, consented children will be prepared for general anaesthesia in the usual way. After&#xD;
      start of anesthesia (=&quot;induction&quot;), adequate face-mask ventilation will be established. The&#xD;
      sealed envelope for randomisation will then be opened. Standard anesthesia will be continued,&#xD;
      either using sevoflurane or propofol (anesthesia depth controlled by Narcotrend, to measure&#xD;
      anesthesia depth using processed EEG waves). They will receive additional non-invasive&#xD;
      monitoring for this study, such as transcutaneous measurement of tcCO2 and O2, NIRS, and&#xD;
      thoracic electrical impedance tomography (EIT, PulmoVista® 500, Draeger, Luebeck, Germany)&#xD;
      All patients will receive neuromuscular blockade medication of 2 x ED95 (standard intubation&#xD;
      dose) to facilitate airway management and total intravenous anesthesia will be installed&#xD;
      (continuous application of i.v. anesthesia medication). Up to two minutes of bag-mask&#xD;
      ventilation with 100% oxygen and flow rates of 6-8L/min will be applied until an expired&#xD;
      oxygen concentration of &gt;90% is reached, as well as an SpO2 of 100% and an transcutaneous CO2&#xD;
      of 30-40mmHg.&#xD;
&#xD;
      For the study intervention, the bag-mask ventilation will be discontinued, and the child will&#xD;
      be left apnoeic (the same happens always during intubation) until the saturation drops to&#xD;
      95%, which is still a low normal value. According randomization, any of the two study&#xD;
      intervention s will be applied (THRIVE therapy with 100% O2 2l/kg/min, THRIVE therapy with&#xD;
      100% O2 4l/kg/min, all via nasal cannulas) while simultaneously guaranteeing an open airway&#xD;
      by using Esmarch's procedure (jaw thrust) and an oral airway (Guedel tube). ECG,&#xD;
      pulse-oximetry, blood pressure, Narcotrend, NIRS, thoracic EIT, PtcO2, PtcCO2 will be&#xD;
      measured continuously over the study period. The time until desaturation from SpO2 100% to&#xD;
      SpO2 95% will be also measured. A chest ultrasound at the end of the intervention will prove&#xD;
      that no pneumothorax developed during the procedure. The study intervention will end at the&#xD;
      time the saturation reaches SpO2 95% or when any other break-up criteria are reached. Bag&#xD;
      mask ventilation will then be re-applied until SpO2 reaches again 100% and the patient will&#xD;
      be treated according to the attending anaesthesiologist to ultimately establish a patent&#xD;
      airway. Break-up criteria during apnoea are: SpO2 below 95%, transcutaneous CO2 above 70&#xD;
      mmHg, or time of apnoea &gt;10 minutes. Drop of NIRS &gt; 30% from baseline. A postmedication&#xD;
      interview will be performed before PACU discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of tcCO2 in mmHg/min</measure>
    <time_frame>10 minutes</time_frame>
    <description>mean tcCO2 increase in mmHg/min during apnoea time, measured transcutaneously.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>desaturation from SpO2 100% to 95%</measure>
    <time_frame>10 minutes</time_frame>
    <description>time (in seconds) until desaturation from SpO2 100% to 95%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tcO2 in mmHg/min</measure>
    <time_frame>10 minutes</time_frame>
    <description>Changes in tcO2 in mmHg/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIRS</measure>
    <time_frame>10 minutes</time_frame>
    <description>changes in brain oxygenation (measured by near infrared spectroscopy (NIRS)) during apnoea time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrical impedance tomography</measure>
    <time_frame>10 minutes</time_frame>
    <description>changes in electrical impedance tomography (EIT) to validate ventilatory effect</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Apnea</condition>
  <condition>Ventilation Therapy; Complications</condition>
  <arm_group>
    <arm_group_label>THRIVE 2L/kg/min using OptiFlow</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>High-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher&amp;Paykel, Auckland, New Zealand.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>THRIVE 4L/kg/min using OptiFlow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After apnea sets in and mask ventilation is successfully established, randomization envelopes are opened and according to group allocation, the following oxygen delivery system is applied.&#xD;
High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher&amp;Paykel, Auckland, New Zealand.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>THRIVE 4L/kg/min</intervention_name>
    <description>High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher&amp;Paykel, Auckland, New Zealand.</description>
    <arm_group_label>THRIVE 4L/kg/min using OptiFlow</arm_group_label>
    <other_name>Optiflow</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>THRIVE 2L/kg/min</intervention_name>
    <description>High-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher&amp;Paykel, Auckland, New Zealand.</description>
    <arm_group_label>THRIVE 2L/kg/min using OptiFlow</arm_group_label>
    <other_name>Optifloe</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  paediatric patients undergoing elective surgery requiring general anesthesia with&#xD;
             intubation at the University Hospital - Inselspital in Bern.&#xD;
&#xD;
          -  ASA physical status 1&amp;2&#xD;
&#xD;
          -  10-15kg&#xD;
&#xD;
          -  legal guardians providing written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known or suspected difficult intubation&#xD;
&#xD;
          -  oxygen dependency&#xD;
&#xD;
          -  congenital heart or lung disease&#xD;
&#xD;
          -  obesity BMI&gt;20kg/m2&#xD;
&#xD;
          -  high aspiration risk (requiring rapid sequence induction intubation).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>4 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Greif, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anesthesia, University Hospital Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inselspital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <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>August 2020</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</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>Consultant Anaesthesia, MD, Principal investigator</investigator_title>
  </responsible_party>
  <keyword>infant</keyword>
  <keyword>airway management</keyword>
  <keyword>apneic oxygenation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</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/NCT03812354
org study id: Riva2018
nct id: NCT03812354
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates under controlled circumstances the concept of THRIVE to improve the
      ventilation and the carbon dioxide elimination, to prolong the apnoea time without
      deoxygenation and to improve safety of airway management in pediatric patients.
Eligible, consented children will be prepared for general anaesthesia in the usual way. After
      start of anesthesia (="induction"), adequate face-mask ventilation will be established. The
      sealed envelope for randomisation will then be opened. Standard anesthesia will be continued,
      either using sevoflurane or propofol (anesthesia depth controlled by Narcotrend, to measure
      anesthesia depth using processed EEG waves). They will receive additional non-invasive
      monitoring for this study, such as transcutaneous measurement of tcCO2 and O2, NIRS, and
      thoracic electrical impedance tomography (EIT, PulmoVista® 500, Draeger, Luebeck, Germany)
      All patients will receive neuromuscular blockade medication of 2 x ED95 (standard intubation
      dose) to facilitate airway management and total intravenous anesthesia will be installed
      (continuous application of i.v. anesthesia medication). Up to two minutes of bag-mask
      ventilation with 100% oxygen and flow rates of 6-8L/min will be applied until an expired
      oxygen concentration of >90% is reached, as well as an SpO2 of 100% and an transcutaneous CO2
      of 30-40mmHg.

      For the study intervention, the bag-mask ventilation will be discontinued, and the child will
      be left apnoeic (the same happens always during intubation) until the saturation drops to
      95%, which is still a low normal value. According randomization, any of the two study
      intervention s will be applied (THRIVE therapy with 100% O2 2l/kg/min, THRIVE therapy with
      100% O2 4l/kg/min, all via nasal cannulas) while simultaneously guaranteeing an open airway
      by using Esmarch's procedure (jaw thrust) and an oral airway (Guedel tube). ECG,
      pulse-oximetry, blood pressure, Narcotrend, NIRS, thoracic EIT, PtcO2, PtcCO2 will be
      measured continuously over the study period. The time until desaturation from SpO2 100% to
      SpO2 95% will be also measured. A chest ultrasound at the end of the intervention will prove
      that no pneumothorax developed during the procedure. The study intervention will end at the
      time the saturation reaches SpO2 95% or when any other break-up criteria are reached. Bag
      mask ventilation will then be re-applied until SpO2 reaches again 100% and the patient will
      be treated according to the attending anaesthesiologist to ultimately establish a patent
      airway. Break-up criteria during apnoea are: SpO2 below 95%, transcutaneous CO2 above 70
      mmHg, or time of apnoea >10 minutes. Drop of NIRS > 30% from baseline. A postmedication
      interview will be performed before PACU discharge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Change of tcCO2 in mmHg/min
time frame: 10 minutes
description: mean tcCO2 increase in mmHg/min during apnoea time, measured transcutaneously.
measure: desaturation from SpO2 100% to 95%
time frame: 10 minutes
description: time (in seconds) until desaturation from SpO2 100% to 95%
measure: tcO2 in mmHg/min
time frame: 10 minutes
description: Changes in tcO2 in mmHg/min
measure: NIRS
time frame: 10 minutes
description: changes in brain oxygenation (measured by near infrared spectroscopy (NIRS)) during apnoea time
measure: Electrical impedance tomography
time frame: 10 minutes
description: changes in electrical impedance tomography (EIT) to validate ventilatory effect
arm group label: THRIVE 2L/kg/min using OptiFlow
arm group type: Active Comparator
description: High-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher&Paykel, Auckland, New Zealand.
arm group label: THRIVE 4L/kg/min using OptiFlow
arm group type: Experimental
description: After apnea sets in and mask ventilation is successfully established, randomization envelopes are opened and according to group allocation, the following oxygen delivery system is applied.
High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher&Paykel, Auckland, New Zealand.
intervention type: Other
intervention name: THRIVE 4L/kg/min
description: High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher&Paykel, Auckland, New Zealand.
arm group label: THRIVE 4L/kg/min using OptiFlow
other name: Optiflow
intervention type: Other
intervention name: THRIVE 2L/kg/min
description: High-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher&Paykel, Auckland, New Zealand.
arm group label: THRIVE 2L/kg/min using OptiFlow
other name: Optifloe
criteria: 
gender: All
minimum age: 1 Year
maximum age: 4 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Greif, MD
role: Study Chair
affiliation: Department of Anesthesia, University Hospital Bern
facility: 
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Insel Gruppe AG, University Hospital Bern
investigator full name: Thomas Riva
investigator title: Consultant Anaesthesia, MD, Principal investigator
mesh term: Nicotine
sharing ipd: No