xml: <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/NCT06037915</url>
    </required_header>
    <id_info>
      <org_study_id>003125</org_study_id>
      <nct_id>NCT06037915</nct_id>
    </id_info>
    <brief_title>Airway Interventions During Intravenous Anesthesia in Children Undergoing Direct Laryngoscopy for Surgical Procedures Using High Flow Nasal Versus Low Flow Oxygen. A Pilot Study.(Flowkid)</brief_title>
    <official_title>Airway Interventions During Intravenous Anesthesia in Children Undergoing Direct Laryngoscopy for Surgical Procedures Using High Flow Nasal Versus Low Flow Oxygen. A Pilot Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Antwerp</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Antwerp</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>
        The goal of this clinical trial is to evaluate possible differences in airway responses and&#xD;
        interventions during intravenous anesthesia for direct laryngoscopy in children when&#xD;
        comparing two oxygenation methods (conventional low flow oxygen supplementation via&#xD;
        nasopharyngeal tube versus Nasal High Flow Therapy with the OptiflowTM system ).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Surgical procedures during direct laryngoscopy is performed under general anesthesia with&#xD;
        spontaneous or controlled ventilation. These therapeutic procedures, such as the&#xD;
        supraglottoplasty, are a challenge for both the surgeon and the anesthesiologist. While the&#xD;
        airway should be freely accessible for the surgeon, the main concern of the anesthesiologist&#xD;
        is adequate sedation, preservation of the free airway and oxygenation. Prevention of under-or&#xD;
        over-sedation, with careful titration of sedation according to patient needs and preservation&#xD;
        of spontaneous ventilation are challenging, especially in children.Traditionally low flow&#xD;
        oxygen supplementation via nasopharyngeal tube was used for oxygenation during the surgery.&#xD;
        However, it is known that 'in adults', the reported safe apnea time can be extended by using&#xD;
        high flow nasal oxygen and this method is therefore increasingly used for oxygenation.&#xD;
        Previous studies have already reported that the application of high-flow 100 percent(%)&#xD;
        oxygen in children allowed for an apnea time of more than 7 minutes without desaturation.&#xD;
        Interestingly, time to desaturation was not lowered when low-flow 100% oxygen via nasal&#xD;
        cannula was used, compared to high flow oxygen.&#xD;
  &#xD;
        The OptiflowTM Nasal High Flow (NHF) Therapy system (Fisher and Paykel Healthcare - Auckland&#xD;
        New Zealand) is a form of non-invasive respiratory therapy (Fig.1). This system can deliver&#xD;
        high levels of oxygen (FiO2 21% up to 100%). The higher flow rates provide a reduction of&#xD;
        dead space and a dynamic, positive airway pressure, both of which can increase alveolar&#xD;
        ventilation. A critical distinctive element of NHF therapy is airway hydration, i.e., heated&#xD;
        humidification. Heating and humidifying not only makes high gas flows tolerable for patients&#xD;
        but also prevents desiccation of the airway epithelium and maintains and improves mucociliary&#xD;
        clearance.The Fisher &amp; Paykel Healthcare Optiflow Junior 2 Nasal Interface is a non-sealing&#xD;
        nasal interface specifically designed for the flow requirements and anatomical features of&#xD;
        neonates, infants and children on NHF therapy.&#xD;
  &#xD;
        In this trial, minor participants scheduled for elective direct laryngoscopy with surgical&#xD;
        intervention will be enrolled, provided that they comply with in-and exclusioncriteria and&#xD;
        that an informed consent was given by the parent or legal guardian. All included children&#xD;
        will be premedicated with midazolam 0.05 mg/kg. Standard monitoring including 3-lead&#xD;
        electrocardiography, non-invasive blood pressure, peripheral pulse-oximetry, respiratory rate&#xD;
        and rectal temperature will be continuously monitored and recorded. To evaluate the depth of&#xD;
        sedation, the NeuroSENSE ® monitor will be installed previous to anesthesia induction. After&#xD;
        induction of anesthesia a 24 Gauge intravenous catheter is placed in a peripheral vein.&#xD;
        Baseline parameters of heart rate and blood pressure will be noted at this timepoint.&#xD;
        Induction of anesthesia will be carried out with sevoflurane and a bolus of dexmedetomidine&#xD;
        of 4mcg/kg will be administered. Maintenance of anesthesia will be accomplished with&#xD;
        dexmedetomidine infused at 2mcg/kg/h and adjusted to clinical needs with top up rate&#xD;
        dexmedetomedine of 0.5 mcg/kg/h. Remifentanil will be infused at 0.3 mcg/kg/min and adjusted&#xD;
        to clinical needs to 0.5 mcg/kg/min.Guidance of the titration of dexmedetomidine/remifentanil&#xD;
        according to clinical signs, is standard of care. Before start of surgery, on visualizing the&#xD;
        vocal cords, one spray of 10% Lidocaïne is delivered to anesthetize the vocal cords. The&#xD;
        included participants will be randomized into two groups: low flow oxygen vs high flow nasal&#xD;
        therapy. The REDCap randomization module will be used to randomize patients. According to&#xD;
        randomization, children will receive Optiflow nasal prongs or nasal pharyngeal tube for&#xD;
        oxygen supplementation. Spontaneous ventilation will be maintained. In case of laryngospasm&#xD;
        and desaturation, propofol will be used as rescue medication. After surgery all children will&#xD;
        be monitored on intensive care or PACU (Post Anesthetic Care Unit) as standard of care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">May 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>Phase 4</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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the incidence of airway interventions</measure>
      <time_frame>during surgery</time_frame>
      <description>defined as the need to interrupt the procedure in order to maintain adequate oxygenation with mask ventilation, introduction of a nasopharyngeal airway or intubation with endotracheal tube</description>
    </primary_outcome>
    <primary_outcome>
      <measure>incidence of desaturation</measure>
      <time_frame>during surgery</time_frame>
      <description>defined as pulse oxygen saturation(SpO2) lower than 90% for more than 30 seconds</description>
    </primary_outcome>
    <primary_outcome>
      <measure>incidence of bradycardia</measure>
      <time_frame>during surgery</time_frame>
      <description>defined as a change of 30 percent beyond the baseline of heart rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>incidence of tachycardia</measure>
      <time_frame>during surgery</time_frame>
      <description>defined as a change of 30 percent beyond the baseline of heart rate</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Comparison of the oropharyngeal mucosa before and after the procedure</measure>
      <time_frame>before induction of anesthesia and at end of surgery</time_frame>
      <description>1= good quality, humid mucosa; 2= acceptable quality; 3= dry mucosa)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Laryngoscopy</condition>
    <condition>Child</condition>
    <condition>Oxygen Therapy</condition>
    <arm_group>
      <arm_group_label>low flow oxygen</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>high flow oxygen</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>low flow oxygen with nasopharyngeal tube</intervention_name>
      <description>low flow oxygen with nasopharyngeal tube</description>
      <arm_group_label>low flow oxygen</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>high flow oxygen with OptiflowTM Nasal High Flow</intervention_name>
      <description>high flow oxygen with OptiflowTM Nasal High Flow</description>
      <arm_group_label>high flow oxygen</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  scheduled for elective direct laryngoscopy with surgical intervention&#xD;
  &#xD;
            -  written informed consent of the parents or legal guardian&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  refusal of informed consent&#xD;
  &#xD;
            -  known allergy for dexmedetomidine&#xD;
  &#xD;
            -  known allergy for remifentanil&#xD;
  &#xD;
            -  pulse oxygen saturation (SpO2) is lower than 85%, at induction of anesthesia&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Month</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vera Saldien, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Antwerp</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vera Saldien, MD</last_name>
      <phone>38214788</phone>
      <phone_ext>+32</phone_ext>
      <email>vera.saldien@uza.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Joke De Wachter</last_name>
      <phone>38213042</phone>
      <phone_ext>+32</phone_ext>
      <email>joke.dewachter@uza.be</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
      <investigator_full_name>Vera Saldien</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037915
  org study id: 003125
  nct id: NCT06037915
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate possible differences in airway responses and
        interventions during intravenous anesthesia for direct laryngoscopy in children when
        comparing two oxygenation methods (conventional low flow oxygen supplementation via
        nasopharyngeal tube versus Nasal High Flow Therapy with the OptiflowTM system ).
  Surgical procedures during direct laryngoscopy is performed under general anesthesia with
        spontaneous or controlled ventilation. These therapeutic procedures, such as the
        supraglottoplasty, are a challenge for both the surgeon and the anesthesiologist. While the
        airway should be freely accessible for the surgeon, the main concern of the anesthesiologist
        is adequate sedation, preservation of the free airway and oxygenation. Prevention of under-or
        over-sedation, with careful titration of sedation according to patient needs and preservation
        of spontaneous ventilation are challenging, especially in children.Traditionally low flow
        oxygen supplementation via nasopharyngeal tube was used for oxygenation during the surgery.
        However, it is known that 'in adults', the reported safe apnea time can be extended by using
        high flow nasal oxygen and this method is therefore increasingly used for oxygenation.
        Previous studies have already reported that the application of high-flow 100 percent(%)
        oxygen in children allowed for an apnea time of more than 7 minutes without desaturation.
        Interestingly, time to desaturation was not lowered when low-flow 100% oxygen via nasal
        cannula was used, compared to high flow oxygen.
  
        The OptiflowTM Nasal High Flow (NHF) Therapy system (Fisher and Paykel Healthcare - Auckland
        New Zealand) is a form of non-invasive respiratory therapy (Fig.1). This system can deliver
        high levels of oxygen (FiO2 21% up to 100%). The higher flow rates provide a reduction of
        dead space and a dynamic, positive airway pressure, both of which can increase alveolar
        ventilation. A critical distinctive element of NHF therapy is airway hydration, i.e., heated
        humidification. Heating and humidifying not only makes high gas flows tolerable for patients
        but also prevents desiccation of the airway epithelium and maintains and improves mucociliary
        clearance.The Fisher & Paykel Healthcare Optiflow Junior 2 Nasal Interface is a non-sealing
        nasal interface specifically designed for the flow requirements and anatomical features of
        neonates, infants and children on NHF therapy.
  
        In this trial, minor participants scheduled for elective direct laryngoscopy with surgical
        intervention will be enrolled, provided that they comply with in-and exclusioncriteria and
        that an informed consent was given by the parent or legal guardian. All included children
        will be premedicated with midazolam 0.05 mg/kg. Standard monitoring including 3-lead
        electrocardiography, non-invasive blood pressure, peripheral pulse-oximetry, respiratory rate
        and rectal temperature will be continuously monitored and recorded. To evaluate the depth of
        sedation, the NeuroSENSE ® monitor will be installed previous to anesthesia induction. After
        induction of anesthesia a 24 Gauge intravenous catheter is placed in a peripheral vein.
        Baseline parameters of heart rate and blood pressure will be noted at this timepoint.
        Induction of anesthesia will be carried out with sevoflurane and a bolus of dexmedetomidine
        of 4mcg/kg will be administered. Maintenance of anesthesia will be accomplished with
        dexmedetomidine infused at 2mcg/kg/h and adjusted to clinical needs with top up rate
        dexmedetomedine of 0.5 mcg/kg/h. Remifentanil will be infused at 0.3 mcg/kg/min and adjusted
        to clinical needs to 0.5 mcg/kg/min.Guidance of the titration of dexmedetomidine/remifentanil
        according to clinical signs, is standard of care. Before start of surgery, on visualizing the
        vocal cords, one spray of 10% Lidocaïne is delivered to anesthetize the vocal cords. The
        included participants will be randomized into two groups: low flow oxygen vs high flow nasal
        therapy. The REDCap randomization module will be used to randomize patients. According to
        randomization, children will receive Optiflow nasal prongs or nasal pharyngeal tube for
        oxygen supplementation. Spontaneous ventilation will be maintained. In case of laryngospasm
        and desaturation, propofol will be used as rescue medication. After surgery all children will
        be monitored on intensive care or PACU (Post Anesthetic Care Unit) as standard of care.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: the incidence of airway interventions
  time frame: during surgery
  description: defined as the need to interrupt the procedure in order to maintain adequate oxygenation with mask ventilation, introduction of a nasopharyngeal airway or intubation with endotracheal tube
  measure: incidence of desaturation
  time frame: during surgery
  description: defined as pulse oxygen saturation(SpO2) lower than 90% for more than 30 seconds
  measure: incidence of bradycardia
  time frame: during surgery
  description: defined as a change of 30 percent beyond the baseline of heart rate
  measure: incidence of tachycardia
  time frame: during surgery
  description: defined as a change of 30 percent beyond the baseline of heart rate
  measure: Comparison of the oropharyngeal mucosa before and after the procedure
  time frame: before induction of anesthesia and at end of surgery
  description: 1= good quality, humid mucosa; 2= acceptable quality; 3= dry mucosa)
  arm group label: low flow oxygen
  arm group type: Active Comparator
  arm group label: high flow oxygen
  arm group type: Active Comparator
  intervention type: Device
  intervention name: low flow oxygen with nasopharyngeal tube
  description: low flow oxygen with nasopharyngeal tube
  arm group label: low flow oxygen
  intervention type: Device
  intervention name: high flow oxygen with OptiflowTM Nasal High Flow
  description: high flow oxygen with OptiflowTM Nasal High Flow
  arm group label: high flow oxygen
  criteria: 
  gender: All
  minimum age: 1 Month
  maximum age: 10 Years
  healthy volunteers: No
  last name: Vera Saldien, MD
  role: Principal Investigator
  affiliation: University Hospital, Antwerp
  last name: Vera Saldien, MD
  phone: 38214788
  phone ext: +32
  email: vera.saldien@uza.be
  last name: Joke De Wachter
  phone: 38213042
  phone ext: +32
  email: joke.dewachter@uza.be
  responsible party type: Principal Investigator
  investigator affiliation: University Hospital, Antwerp
  investigator full name: Vera Saldien
  investigator title: Principal investigator
  sharing ipd: No