<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/NCT02979067</url>
  </required_header>
  <id_info>
    <org_study_id>2016-01516</org_study_id>
    <nct_id>NCT02979067</nct_id>
  </id_info>
  <brief_title>Improvement of Oxygenation During Apnoea by i-THRIVE</brief_title>
  <acronym>i-Thrive</acronym>
  <official_title>Improvement of Oxygenation During Apnoea by i-THRIVE (Infant Transnasal Humidified Rapid Insufflation Ventilatory Exchange): A Single-centre Prospective Randomized Controlled Trial.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Improvement of oxygenation during apnoea by i-THRIVE Infant Transnasal Humidified Rapid&#xD;
      Insufflation Ventilatory Exchange A single-centre prospective randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      High-Flow nasal cannula therapy is the administration of heated, humidified and blended&#xD;
      air/oxygen via nasal cannula at rates of at least 2 L/kg bodyweight /min. This high-flow&#xD;
      nasal cannula therapy was developed in neonatal intensive care unit for preterm babies with&#xD;
      respiratory pauses as an alternative to continuous pressure support (CPAP). Due to its ease&#xD;
      of use and safety to apply to a wide range of indication, this oxygen delivery therapy is&#xD;
      increasingly gaining interest for providing respiratory support in paediatric and adult&#xD;
      patients with respiratory failure in the ICU. High-flow nasal cannula therapy is applied in&#xD;
      preterm infant with respiratory distress syndrome, apnoea of prematurity or a respiratory&#xD;
      support after extubation. In the adult population the use of HFNCT focuses on hypoxemic&#xD;
      respiratory failure and improvement reduction of hypoxemia during intubation in the&#xD;
      anesthesia environment. A new application for high-flow nasal cannula therapy in adults is&#xD;
      the extension of apnoea time in patients with difficult airways who are undergoing general&#xD;
      anesthesia. In this environment a new term for this kind of oxygen therapy was created:&#xD;
      THRIVE transnasal humidified rapid-insufflation ventilatory exchange. To distinguish this&#xD;
      kind of high-flow nasal cannula therapy in apnoeic patients from the one in the paediatric&#xD;
      ICU or ward the investigators use the term i-THRIVE for infant transnasal humidified rapid&#xD;
      insufflation ventilation exchange.&#xD;
&#xD;
      Due to the increased oxygen consumption and the reduced functional residual capacity,&#xD;
      neonates, infants, and small children have a reduced apnoea tolerance compared to adults.&#xD;
      Furthermore infants and small children have a greater closing capacity, which increases the&#xD;
      airway collapse under general anesthesia and muscle paralysis. A direct consequence is that&#xD;
      hypoxemia is very likely to occur after cessation of spontaneous or assisted ventilation&#xD;
      during induction of anesthesia. Apnoea without supplemental oxygen leads to hypoxemia in a&#xD;
      1-year-old infant without preoxygenation within seconds. All paediatric (and adult) patients&#xD;
      undergoing general anesthesia have at least a brief period of apnoea during intubation&#xD;
      between the time the face-mask is removed from the patient and the tube is placed in the&#xD;
      trachea. Therefore, at least short phases of deoxygenation may occur.&#xD;
&#xD;
      However if anesthesia needs to be provided in emergency situations or in the presence of a&#xD;
      difficult airway, the rate of complication increases rapidly. In these circumstances methods&#xD;
      that reduce desaturation incidents during prolonged difficult intubation are desirable. Due&#xD;
      to oxygen toxicity in neonates or small children, prevention of hypoxemia with oxygen&#xD;
      concentration below 60% would be favourable in this setting. Despite promising pilot results&#xD;
      with high-flow nasal cannula therapy, it is unknown whether this technique is superior to&#xD;
      low-flow oxygenation with high concentration and whether it is necessary to apply high-flow&#xD;
      nasal cannula therapy with high (80-100%) versus low (30-50%) concentration oxygen.&#xD;
&#xD;
      This study investigates under controlled circumstances the concept of i-THRIVE to prolong the&#xD;
      apnoea time without deoxygenation and to improve safety of airway management in paediatric&#xD;
      patients. Furthermore, this study enables to quantify the effects of different oxygen&#xD;
      concentrations with high-flow nasal cannula therapy and distinguishes it better from&#xD;
      conventional low-flow apnoeic oxygenation methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time until desaturation from SpO2 100% to 95% measured by pulse oxymetry</measure>
    <time_frame>up to ten minutes during intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>TcCO2mmHg level</measure>
    <time_frame>study intervention, around 15 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TcO2mmHg level</measure>
    <time_frame>study intervention, around 15 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Preoxygenation</condition>
  <arm_group>
    <arm_group_label>High-flow 100% oxygen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nasal oxygen flow</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-flow 100% oxygen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nasal oxygen flow</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-flow 30% oxygen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nasal oxygen flow</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nasal oxygen flow</intervention_name>
    <description>Nasal oxygen flow during apnoea</description>
    <arm_group_label>High-flow 100% oxygen</arm_group_label>
    <arm_group_label>High-flow 30% oxygen</arm_group_label>
    <arm_group_label>Low-flow 100% oxygen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  10-20 kg&#xD;
&#xD;
          -  ASA 1+2&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Speaking German&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Difficult intubation&#xD;
&#xD;
          -  Oxygen dependency&#xD;
&#xD;
          -  Congenital heart or lung disease&#xD;
&#xD;
          -  BMI &gt;30g/m2&#xD;
&#xD;
          -  High aspiration risk&#xD;
&#xD;
          -  nasal obstruction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Greif, MD MME FERC</last_name>
    <role>Study Chair</role>
    <affiliation>University hospital Bern and University of Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bern University Hospital and University of Bern</name>
      <address>
        <city>Bern</city>
        <zip>3011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>May 11, 2017</last_update_submitted>
  <last_update_submitted_qc>May 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Apnoea time, preoxygenation, difficult airway, emergency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
  </condition_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/NCT02979067
org study id: 2016-01516
nct id: NCT02979067
lead sponsor: 
has dmc: No
Improvement of oxygenation during apnoea by i-THRIVE Infant Transnasal Humidified Rapid
      Insufflation Ventilatory Exchange A single-centre prospective randomized controlled trial.
High-Flow nasal cannula therapy is the administration of heated, humidified and blended
      air/oxygen via nasal cannula at rates of at least 2 L/kg bodyweight /min. This high-flow
      nasal cannula therapy was developed in neonatal intensive care unit for preterm babies with
      respiratory pauses as an alternative to continuous pressure support (CPAP). Due to its ease
      of use and safety to apply to a wide range of indication, this oxygen delivery therapy is
      increasingly gaining interest for providing respiratory support in paediatric and adult
      patients with respiratory failure in the ICU. High-flow nasal cannula therapy is applied in
      preterm infant with respiratory distress syndrome, apnoea of prematurity or a respiratory
      support after extubation. In the adult population the use of HFNCT focuses on hypoxemic
      respiratory failure and improvement reduction of hypoxemia during intubation in the
      anesthesia environment. A new application for high-flow nasal cannula therapy in adults is
      the extension of apnoea time in patients with difficult airways who are undergoing general
      anesthesia. In this environment a new term for this kind of oxygen therapy was created:
      THRIVE transnasal humidified rapid-insufflation ventilatory exchange. To distinguish this
      kind of high-flow nasal cannula therapy in apnoeic patients from the one in the paediatric
      ICU or ward the investigators use the term i-THRIVE for infant transnasal humidified rapid
      insufflation ventilation exchange.

      Due to the increased oxygen consumption and the reduced functional residual capacity,
      neonates, infants, and small children have a reduced apnoea tolerance compared to adults.
      Furthermore infants and small children have a greater closing capacity, which increases the
      airway collapse under general anesthesia and muscle paralysis. A direct consequence is that
      hypoxemia is very likely to occur after cessation of spontaneous or assisted ventilation
      during induction of anesthesia. Apnoea without supplemental oxygen leads to hypoxemia in a
      1-year-old infant without preoxygenation within seconds. All paediatric (and adult) patients
      undergoing general anesthesia have at least a brief period of apnoea during intubation
      between the time the face-mask is removed from the patient and the tube is placed in the
      trachea. Therefore, at least short phases of deoxygenation may occur.

      However if anesthesia needs to be provided in emergency situations or in the presence of a
      difficult airway, the rate of complication increases rapidly. In these circumstances methods
      that reduce desaturation incidents during prolonged difficult intubation are desirable. Due
      to oxygen toxicity in neonates or small children, prevention of hypoxemia with oxygen
      concentration below 60% would be favourable in this setting. Despite promising pilot results
      with high-flow nasal cannula therapy, it is unknown whether this technique is superior to
      low-flow oxygenation with high concentration and whether it is necessary to apply high-flow
      nasal cannula therapy with high (80-100%) versus low (30-50%) concentration oxygen.

      This study investigates under controlled circumstances the concept of i-THRIVE to prolong the
      apnoea time without deoxygenation and to improve safety of airway management in paediatric
      patients. Furthermore, this study enables to quantify the effects of different oxygen
      concentrations with high-flow nasal cannula therapy and distinguishes it better from
      conventional low-flow apnoeic oxygenation methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Time until desaturation from SpO2 100% to 95% measured by pulse oxymetry
time frame: up to ten minutes during intervention
measure: TcCO2mmHg level
time frame: study intervention, around 15 minutes
measure: TcO2mmHg level
time frame: study intervention, around 15 minutes
arm group label: High-flow 100% oxygen
arm group type: Active Comparator
description: Nasal oxygen flow
arm group label: Low-flow 100% oxygen
arm group type: Active Comparator
description: Nasal oxygen flow
arm group label: High-flow 30% oxygen
arm group type: Active Comparator
description: Nasal oxygen flow
intervention type: Procedure
intervention name: Nasal oxygen flow
description: Nasal oxygen flow during apnoea
arm group label: High-flow 100% oxygen
arm group label: High-flow 30% oxygen
arm group label: Low-flow 100% oxygen
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Robert Greif, MD MME FERC
role: Study Chair
affiliation: University hospital Bern and University of Bern
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Apnea
sharing ipd: No