<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/NCT03298217</url>
  </required_header>
  <id_info>
    <org_study_id>UF9868</org_study_id>
    <nct_id>NCT03298217</nct_id>
  </id_info>
  <brief_title>Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis</brief_title>
  <acronym>DEBIB</acronym>
  <official_title>Peak Tidal Inspiratory Flow in Infants With Moderate to Severe Acute Viral Bronchiolitis: a Physiologic Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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 aim of this study is to measure the peak tidal inspiratory flow (PTIF), using&#xD;
      spirometry, in young infants with moderate to severe acute viral bronchiolitis (AVB).&#xD;
&#xD;
      PTIF is important to consider for the management of AVB with High Flow Nasal Cannulae (HFNC).&#xD;
      Indeed, efficiency with HFNC is optimal provided that the settled flow is equal or higher&#xD;
      than the patient's PTIF. However, PTIF values in infants with AVB have never been determined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      HFNC allows the administration of a heated and humidified mixture of air and oxygen at high&#xD;
      flows. This device has been widely adopted in pediatric intensive care units (PICUs) and for&#xD;
      interhospital transport of critically ill children, as the system is easily set up and is&#xD;
      well tolerated by patients. In the context of AVB, retrospective audits and observational&#xD;
      studies have suggested promising outcomes on both physiological and clinical variables.&#xD;
      However, in less than 6 months old infants with moderate to severe AVB, the failure rate with&#xD;
      this device - defined as worsening of respiratory failure or the occurrence of discomfort or&#xD;
      severe apnea - remains high, from 30% to 50% in key studies.&#xD;
&#xD;
      HFNC flow setting remains empiric, 2 L/kg/min being used by most teams. A potential&#xD;
      explanation for this high failure rate is that the flow usually used is lower than the&#xD;
      patient's inspiratory flow. The aim of this study is to determine peak tidal inspiratory flow&#xD;
      (PTIF) values in infants up to 6 months old with moderate to severe AVB.&#xD;
&#xD;
      PTIF will be evaluated with a spirometer connected to a face mask during 20 cycles of&#xD;
      spontaneous ventilation. The measurements will be performed within the first 24 hours of&#xD;
      hospitalization in the department of Neonatal and Pediatric Intensive Care of Arnaud de&#xD;
      Villeneuve University Hospital at Montpellier (France).&#xD;
&#xD;
      Statistical analysis Relation between the DIP and Silverman score, mWCAS, RR, LOS will be&#xD;
      expressed with parametric and non-parametric correlation coefficients according to the&#xD;
      distribution of the data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 21, 2017</start_date>
  <completion_date type="Actual">January 16, 2019</completion_date>
  <primary_completion_date type="Actual">January 16, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of peak or peak inspiration flow (PTIF=peak tidal inspiratory flow)</measure>
    <time_frame>1 day but within 24 hours of patient admission</time_frame>
    <description>Measurement of peak or peak inspiratory flow will be performed by spirometry using a spirometer within 24 hours of patient admission. Evaluation will take place within the first 24 hours of hospitalization in the department of Neonatal and Pediatric Intensive Care among patients with moderate to severe AVB.&#xD;
Description: Application of the spirometer for the recording of 20 consecutives spontaneous respiratory cycles for PTIF (l/kg/min) measurements.&#xD;
Primary outcome: average (+/-SD) of 20 consecutives PTIF.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with a spontaneous PTIF higher than 2 L/kg/min</measure>
    <time_frame>1 day but within 24 hours of patient admission</time_frame>
    <description>Proportion of patients with a spontaneous PTIF higher than 2 L/kg/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between PTIF and Silverman score</measure>
    <time_frame>1 day but within 24 hours of patient admission</time_frame>
    <description>Correlation between PTIF (l/kg/min) and Silverman score (0 to 10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between PTIF and modified Wood's clinical asthma score</measure>
    <time_frame>1 day but within 24 hours of patient admission</time_frame>
    <description>Correlation between PTIF (l/kg/min) and modified Wood's clinical asthma score(m-WCAS) (0 to 10)&#xD;
Correlation between PTIF (l/kg/min) and respiratory rate (FR) (breath/min)&#xD;
Correlation between PTIF (l/kg/min) and carbon dioxide (CO2) (mmHg) measured by capillary blood gases or with transcutaneous electrodes, duration of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between PTIF and respiratory rate (FR)</measure>
    <time_frame>1 day but within 24 hours of patient admission</time_frame>
    <description>Correlation between PTIF (l/kg/min) and respiratory rate (FR) (breath/min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between PTIF and carbon dioxide (CO2)</measure>
    <time_frame>1 day</time_frame>
    <description>Correlation between PTIF (l/kg/min) and carbon dioxide (CO2) (mmHg) measured by capillary blood gases or with transcutaneous electrodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization</measure>
    <time_frame>1 day at the end of the hospitalization</time_frame>
    <description>Duration of hospitalization</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>Bronchiolitis patients sverity</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In patients with bronchiolitis mWCAS / 3-5 : Measurement of the peak tidal inspiratory flow (PTIF)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Measurement of the peak tidal inspiratory flow (PTIF)</intervention_name>
    <description>In patients with bronchiolitis sverity mWCAS / 3-5 :&#xD;
Nasopharyngeal aspiration and comfortable placement of the infant upon admission; Clinical evaluation: respiratory rate, respiratory distress scores rating (Silverman and m-WCAS); If the patient is eligible: information and collection of parental consent; If signed parental consent obtained: progressive (on at least 10 min) withdrawal of HFNC support and maintenance if necessary of conventional oxygen therapy (maximum 1 L/min); Application of the spirometer for the recording of 20 consecutive spontaneous respiratory cycles for PTIF measurements; Respiratory support with HFNC; flow adapted to the need of the patients (equal to the measured PTIF).</description>
    <arm_group_label>Bronchiolitis patients sverity</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants up to 6 months old, with AVB according to conventional clinical criteria;&#xD;
&#xD;
          -  Admitted to the department of Neonatal and Pediatric Intensive Care at Arnaud de&#xD;
             Villeneuve University Hospital in Montpellier (France);&#xD;
&#xD;
          -  Supported with HFNC, according to the department's protocol (2 &lt; m-WCAS &lt; 5);&#xD;
&#xD;
          -  Not requiring immediate intubation for invasive ventilation;&#xD;
&#xD;
          -  Signed parental consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infant with heart disease, cystic fibrosis or neuromuscular disorder;&#xD;
&#xD;
          -  Infant requiring ventilatory support with nasal continuous positive pressure (nCPAP)&#xD;
             or with HFNC and without possibility of weaning, including for a few minutes;&#xD;
&#xD;
          -  Intolerance of the spirometry mask.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christophe MILESI, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>December 23, 2021</last_update_submitted>
  <last_update_submitted_qc>December 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inspiratory flow</keyword>
  <keyword>High flow nasal cannula, spirometry</keyword>
  <keyword>spirometry</keyword>
  <keyword>physiologic study</keyword>
  <keyword>Bronchiolitis patients sverity score mWCAS/ 3-5.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiolitis</mesh_term>
    <mesh_term>Bronchiolitis, Viral</mesh_term>
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT03298217
org study id: UF9868
nct id: NCT03298217
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This aim of this study is to measure the peak tidal inspiratory flow (PTIF), using
      spirometry, in young infants with moderate to severe acute viral bronchiolitis (AVB).

      PTIF is important to consider for the management of AVB with High Flow Nasal Cannulae (HFNC).
      Indeed, efficiency with HFNC is optimal provided that the settled flow is equal or higher
      than the patient's PTIF. However, PTIF values in infants with AVB have never been determined.
HFNC allows the administration of a heated and humidified mixture of air and oxygen at high
      flows. This device has been widely adopted in pediatric intensive care units (PICUs) and for
      interhospital transport of critically ill children, as the system is easily set up and is
      well tolerated by patients. In the context of AVB, retrospective audits and observational
      studies have suggested promising outcomes on both physiological and clinical variables.
      However, in less than 6 months old infants with moderate to severe AVB, the failure rate with
      this device - defined as worsening of respiratory failure or the occurrence of discomfort or
      severe apnea - remains high, from 30% to 50% in key studies.

      HFNC flow setting remains empiric, 2 L/kg/min being used by most teams. A potential
      explanation for this high failure rate is that the flow usually used is lower than the
      patient's inspiratory flow. The aim of this study is to determine peak tidal inspiratory flow
      (PTIF) values in infants up to 6 months old with moderate to severe AVB.

      PTIF will be evaluated with a spirometer connected to a face mask during 20 cycles of
      spontaneous ventilation. The measurements will be performed within the first 24 hours of
      hospitalization in the department of Neonatal and Pediatric Intensive Care of Arnaud de
      Villeneuve University Hospital at Montpellier (France).

      Statistical analysis Relation between the DIP and Silverman score, mWCAS, RR, LOS will be
      expressed with parametric and non-parametric correlation coefficients according to the
      distribution of the data.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Measurement of peak or peak inspiration flow (PTIF=peak tidal inspiratory flow)
time frame: 1 day but within 24 hours of patient admission
description: Measurement of peak or peak inspiratory flow will be performed by spirometry using a spirometer within 24 hours of patient admission. Evaluation will take place within the first 24 hours of hospitalization in the department of Neonatal and Pediatric Intensive Care among patients with moderate to severe AVB.
Description: Application of the spirometer for the recording of 20 consecutives spontaneous respiratory cycles for PTIF (l/kg/min) measurements.
Primary outcome: average (+/-SD) of 20 consecutives PTIF.
measure: Proportion of patients with a spontaneous PTIF higher than 2 L/kg/min
time frame: 1 day but within 24 hours of patient admission
description: Proportion of patients with a spontaneous PTIF higher than 2 L/kg/min
measure: Correlation between PTIF and Silverman score
time frame: 1 day but within 24 hours of patient admission
description: Correlation between PTIF (l/kg/min) and Silverman score (0 to 10)
measure: Correlation between PTIF and modified Wood's clinical asthma score
time frame: 1 day but within 24 hours of patient admission
description: Correlation between PTIF (l/kg/min) and modified Wood's clinical asthma score(m-WCAS) (0 to 10)
Correlation between PTIF (l/kg/min) and respiratory rate (FR) (breath/min)
Correlation between PTIF (l/kg/min) and carbon dioxide (CO2) (mmHg) measured by capillary blood gases or with transcutaneous electrodes, duration of hospitalization
measure: Correlation between PTIF and respiratory rate (FR)
time frame: 1 day but within 24 hours of patient admission
description: Correlation between PTIF (l/kg/min) and respiratory rate (FR) (breath/min)
measure: Correlation between PTIF and carbon dioxide (CO2)
time frame: 1 day
description: Correlation between PTIF (l/kg/min) and carbon dioxide (CO2) (mmHg) measured by capillary blood gases or with transcutaneous electrodes
measure: Duration of hospitalization
time frame: 1 day at the end of the hospitalization
description: Duration of hospitalization
arm group label: Bronchiolitis patients sverity
arm group type: Other
description: In patients with bronchiolitis mWCAS / 3-5 : Measurement of the peak tidal inspiratory flow (PTIF)
intervention type: Device
intervention name: Measurement of the peak tidal inspiratory flow (PTIF)
description: In patients with bronchiolitis sverity mWCAS / 3-5 :
Nasopharyngeal aspiration and comfortable placement of the infant upon admission; Clinical evaluation: respiratory rate, respiratory distress scores rating (Silverman and m-WCAS); If the patient is eligible: information and collection of parental consent; If signed parental consent obtained: progressive (on at least 10 min) withdrawal of HFNC support and maintenance if necessary of conventional oxygen therapy (maximum 1 L/min); Application of the spirometer for the recording of 20 consecutive spontaneous respiratory cycles for PTIF measurements; Respiratory support with HFNC; flow adapted to the need of the patients (equal to the measured PTIF).
arm group label: Bronchiolitis patients sverity
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: No
last name: Christophe MILESI, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Bronchiolitis
mesh term: Bronchiolitis, Viral
mesh term: Respiratory Aspiration
sharing ipd: Undecided
ipd description: NC