<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/NCT03835858</url>
  </required_header>
  <id_info>
    <org_study_id>6.0</org_study_id>
    <nct_id>NCT03835858</nct_id>
  </id_info>
  <brief_title>Safety of Airway Clearance in Non-hospitalized Infants With Acute Viral Bronchiolitis</brief_title>
  <official_title>Safety of Airway Clearance Combined With Bronchodilator and Hypertonic Saline in Non-hospitalized Infants With Acute Viral Bronchiolitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guadarrama Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fisiobronquial Clínicas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guadarrama Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Bronchiolitis is a disease that can occur in a mild form and moderate, and often does not&#xD;
      require hospitalization. The technique of prolonged slow expiration followed by cough caused&#xD;
      in children not hospitalized with mild and moderate bronchiolitis can improve clinical&#xD;
      severity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Once each patient legal guardians has signed the informed consent document and it has been&#xD;
      verified that the inclusion criteria are met, it will be assigned the same identification&#xD;
      number (ID) that is related to its Clinical History (CH) by simple coding; custody of the&#xD;
      file with the relationship of each ID with its CH will be the responsibility of the principal&#xD;
      investigator.&#xD;
&#xD;
      Before starting the treatment protocol, a blind evaluator treats the was assigned the patient&#xD;
      classifies the child according to the initial score of clinical severity proposed by Wang, in&#xD;
      addition to the measurement of SO2 and heart rate measured through a pulse oximeter.&#xD;
&#xD;
      The protocol consists of 20 minutes of FR based on nasal washes in sitting, prolonged slow&#xD;
      expiration: passive technique of expiratory help applied to the baby through a slow&#xD;
      thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing&#xD;
      to the residual volume. The physiotherapist through the provoked cough or stimulation of the&#xD;
      trachea achieves the expectoration of the sputum.&#xD;
&#xD;
      Care must be taken during the maneuvers of maintaining a position of the infant in supine&#xD;
      decubitus in 30 degrees of slope, to avoid episodes of gastroesophageal reflux and decrease&#xD;
      the risk of vomiting.&#xD;
&#xD;
      They are considered as criteria of cessation of the physiotherapeutic intervention,&#xD;
      alterations abrupt of the respiratory rhythm (brady or tachypnea), stare, ocular revulsion,&#xD;
      hiccups or hypertonia and changes in skin color (pallor or cyanosis). In addition to these&#xD;
      clinical manifestations, it establishes that if the father or legal guardian demands it, the&#xD;
      application of the protocol would be terminated.&#xD;
&#xD;
      In order to evaluate the immediate effect of the protocol, which is established as the effect&#xD;
      evaluated 10 minutes immediately after the intervention was applied, the doctor again&#xD;
      performs a measurement of SO2, heart rate and respiratory rate, and classify again according&#xD;
      to the criteria of Wang's clinical severity scale and anotate any adverse event. At 20&#xD;
      minutes the same medical evaluator performs the same assessment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">May 5, 2019</completion_date>
  <primary_completion_date type="Actual">May 5, 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>
    <intervention_model_description>Prospective, quasi-experimental study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wang clinical severity scale</measure>
    <time_frame>12 weeks</time_frame>
    <description>The clinical severity scale of Wang evaluates the respiratory rate, the presence of wheezing and intercostal retraction, and the patient's general condition, puncturing each dimension from 0 (the possible state) to 3 (values within normal), in addition to offer different cut points for children with more or less than 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>12 weeks</time_frame>
    <description>Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">265</enrollment>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>Respiratory physiotherapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The protocol consists of 20 minutes of FR based on nasal washes in sitting, prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing to the residual volume. The physiotherapist through the the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Respiratory physiotherapy</intervention_name>
    <description>The protocol consists of 20 minutes of FR based on nasal washes in sitting, prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing to the residual volume. The physiotherapist through the the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.</description>
    <arm_group_label>Respiratory physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must meet the following inclusion criteria:&#xD;
&#xD;
          -  Have an age between 2 months and 12 months.&#xD;
&#xD;
          -  Have medical diagnosis of first episode of BQ of maximum 48 hours of evolution.&#xD;
&#xD;
          -  Not previously received respiratory physiotherapy since its diagnosis.&#xD;
&#xD;
          -  Have the informed consent signed by the child's legal guardians.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The exclusion criteria are:&#xD;
&#xD;
          -  Acute BQ with score&gt; 9 according to the Wang clinical scale.&#xD;
&#xD;
          -  Pathology associated cardiac, neurological or traumatic.&#xD;
&#xD;
          -  Previous hospitalizations for wheezing.&#xD;
&#xD;
          -  Medical diagnosis of recurrent sibilant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J. Nicolas Cuenca Zaldivar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guadarrama Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>J.Nicolas Cuenca Zaldivar</name>
      <address>
        <city>Guadarrama</city>
        <state>Madrid</state>
        <zip>28440</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>May 11, 2020</last_update_submitted>
  <last_update_submitted_qc>May 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guadarrama Hospital</investigator_affiliation>
    <investigator_full_name>J. Nicolas Cuenca Zaldivar</investigator_full_name>
    <investigator_title>Rehabilitation Service Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Physical Therapy</keyword>
  <keyword>Respiratory</keyword>
  <keyword>Pediatric</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>
  </condition_browse>
  <!-- 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/NCT03835858
org study id: 6.0
nct id: NCT03835858
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Bronchiolitis is a disease that can occur in a mild form and moderate, and often does not
      require hospitalization. The technique of prolonged slow expiration followed by cough caused
      in children not hospitalized with mild and moderate bronchiolitis can improve clinical
      severity
Once each patient legal guardians has signed the informed consent document and it has been
      verified that the inclusion criteria are met, it will be assigned the same identification
      number (ID) that is related to its Clinical History (CH) by simple coding; custody of the
      file with the relationship of each ID with its CH will be the responsibility of the principal
      investigator.

      Before starting the treatment protocol, a blind evaluator treats the was assigned the patient
      classifies the child according to the initial score of clinical severity proposed by Wang, in
      addition to the measurement of SO2 and heart rate measured through a pulse oximeter.

      The protocol consists of 20 minutes of FR based on nasal washes in sitting, prolonged slow
      expiration: passive technique of expiratory help applied to the baby through a slow
      thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing
      to the residual volume. The physiotherapist through the provoked cough or stimulation of the
      trachea achieves the expectoration of the sputum.

      Care must be taken during the maneuvers of maintaining a position of the infant in supine
      decubitus in 30 degrees of slope, to avoid episodes of gastroesophageal reflux and decrease
      the risk of vomiting.

      They are considered as criteria of cessation of the physiotherapeutic intervention,
      alterations abrupt of the respiratory rhythm (brady or tachypnea), stare, ocular revulsion,
      hiccups or hypertonia and changes in skin color (pallor or cyanosis). In addition to these
      clinical manifestations, it establishes that if the father or legal guardian demands it, the
      application of the protocol would be terminated.

      In order to evaluate the immediate effect of the protocol, which is established as the effect
      evaluated 10 minutes immediately after the intervention was applied, the doctor again
      performs a measurement of SO2, heart rate and respiratory rate, and classify again according
      to the criteria of Wang's clinical severity scale and anotate any adverse event. At 20
      minutes the same medical evaluator performs the same assessment.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, quasi-experimental study
primary purpose: Treatment
masking: None (Open Label)
measure: Wang clinical severity scale
time frame: 12 weeks
description: The clinical severity scale of Wang evaluates the respiratory rate, the presence of wheezing and intercostal retraction, and the patient's general condition, puncturing each dimension from 0 (the possible state) to 3 (values within normal), in addition to offer different cut points for children with more or less than 6 months.
measure: Oxygen saturation
time frame: 12 weeks
description: Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).
arm group label: Respiratory physiotherapy
arm group type: Other
description: The protocol consists of 20 minutes of FR based on nasal washes in sitting, prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing to the residual volume. The physiotherapist through the the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.
intervention type: Other
intervention name: Respiratory physiotherapy
description: The protocol consists of 20 minutes of FR based on nasal washes in sitting, prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing to the residual volume. The physiotherapist through the the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.
arm group label: Respiratory physiotherapy
criteria: 
gender: All
minimum age: 2 Months
maximum age: 12 Months
healthy volunteers: No
last name: J. Nicolas Cuenca Zaldivar
role: Principal Investigator
affiliation: Guadarrama Hospital
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Guadarrama Hospital
investigator full name: J. Nicolas Cuenca Zaldivar
investigator title: Rehabilitation Service Principal Investigator
mesh term: Bronchiolitis
mesh term: Bronchiolitis, Viral