<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/NCT03835936</url>
  </required_header>
  <id_info>
    <org_study_id>5.0</org_study_id>
    <nct_id>NCT03835936</nct_id>
  </id_info>
  <brief_title>Treatment of Pediatric Bronchiolitis</brief_title>
  <official_title>Immediate Effects and Safety of High-frequency Chest Wall Oscillation Compared to Airway Clearance Techniques 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 (BQ) is the acute viral infection of the tract respiratory syndrome in infants&#xD;
      that affects the bronchioles of babies under 24 months of age. Respiratory physiotherapy (RF)&#xD;
      appears as a treatment measure complementary in the clinical guidelines and consensus on the&#xD;
      management of the BQ.&#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;
      The assignment will be made at the time of query according to a table of random numbers&#xD;
      previously established and that it will only be known by physiotherapists.&#xD;
&#xD;
      Before starting the treatment protocol, a blind evaluator who does not know the treatment to&#xD;
      which the patient is assigned, classifies the child according to the initial score of&#xD;
      clinical severity proposed by Wang, in addition to the measurement of SO2 and frequency heart&#xD;
      rate through a pulse oximeter. The measurement of the amount of sputum collected in a meter&#xD;
      measuring cup, once the respiratory physiotherapy session is finished, it will be done in a&#xD;
      calibrated weight in both groups.&#xD;
&#xD;
      The protocol in the manual maneuvers group consists of 20 minutes of FR based on prolonged&#xD;
      slow expiration and coughing provoked. Is apassive technique of expiratory help applied to&#xD;
      the baby through a slow thoracic-abdominal pressure that begins at the end of spontaneous&#xD;
      expiration and continues to the residual volume. The physiotherapist through the cough&#xD;
      provoked or stimulation of the trachea gets expectoration of sputum, to be able to assess its&#xD;
      weight.&#xD;
&#xD;
      The protocol in the high frequency compression chest wall group consists of the same protocol&#xD;
      as the respiratory physiotherapy Group plus high frequency compression chest wall applied&#xD;
      with Smart Vest® device, with a fixed frequency of 13 Hz and a time 15 min. The selected mode&#xD;
      will be the normal (fixed parameters) and the pressure of 4 units (12 cm H2O). The patient&#xD;
      remains seated on his parents, and with a cotton garment between the vest and the skin of the&#xD;
      patient to prevent skin lesions.&#xD;
&#xD;
      Attention must be paid during maneuvers to maintain a position of infant in supine decubitus&#xD;
      in 30 degrees of slope, to avoid episodes of gastroesophageal reflux and decrease the risk of&#xD;
      vomiting.&#xD;
&#xD;
      Criteria for cessation of physiotherapeutic intervention, alterations will be considered&#xD;
      abrupt of the respiratory rhythm (brady or tachypnea), stare, ocular revulsion, hiccups or&#xD;
      hypertonia and changes in skin color (pallor or cyanosis). In addition to these&#xD;
      manifestations clinics, it is established that if the parent or legal guardian so requires,&#xD;
      the the application of the protocol.&#xD;
&#xD;
      After 10 and 20 minutes of finishing both groups, the doctor again makes a measurement of&#xD;
      mucus volume, SO2, heart and respiratory rate, and classify again according to the criteria&#xD;
      of Wang's clinical severity scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">May 10, 2019</completion_date>
  <primary_completion_date type="Actual">May 10, 2019</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>
    <intervention_model_description>Single-blind controlled clinical trial</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>
  <secondary_outcome>
    <measure>Heart rate</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>
  <secondary_outcome>
    <measure>Amount of sputum</measure>
    <time_frame>12 weeks</time_frame>
    <description>The measurement of the amount of sputum collected in a metric measuring cup, once the session is finished, will be done in a calibrated weight</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Bronchiolitis</condition>
  <arm_group>
    <arm_group_label>Manual maneuvers physiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The protocol of physiotherapy treatment techniques consists of 20 minutes of FR based on prolonged slow expiration and cough provoked.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High frequency compression chest wall</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The protocol consists in the application of the Smart Vest® device for high frequency compression of the chest wall, with a fixed frequency of 13 Hz and a time of 15 minutes. Then during 20 minutes will apply the same protocol as in the manual maneuvers group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High frequency compression of the chest wall group</intervention_name>
    <description>The protocol in the high frequency compression of the chest wall group device consists of the Smart Vest® application, with a fixed frequency of 13 Hz and a time of 15 minutes. The selected mode will be the normal (fixed parameters) and the pressure of 4 units (12 cm H2O). The patient remains seated on his parents, and with a cotton garment between the vest and the skin of the patient to prevent skin lesions.</description>
    <arm_group_label>High frequency compression chest wall</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual maneuvers physiotherapy group</intervention_name>
    <description>20 minutes of manual maneuvers physiotherapy based on prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of spontaneous expiration and continues to the residual volume. The physiotherapist through the cough provoked or stimulation of the trachea gets expectoration of sputum, to be able to assess its weight.</description>
    <arm_group_label>High frequency compression chest wall</arm_group_label>
    <arm_group_label>Manual maneuvers 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 a medical diagnosis of the first episode of BQ.&#xD;
&#xD;
          -  Have the informed consent signed by the child's legal guardians.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        The criteria of exclusion are:&#xD;
&#xD;
          -  BQ in acute phase with score&gt; 9 according to Wang clinical scale.&#xD;
&#xD;
          -  Associated cardiac, neurological or traumatic pathology.&#xD;
&#xD;
          -  Previous hospitalization 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>June 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>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 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>
  </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/NCT03835936
org study id: 5.0
nct id: NCT03835936
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Bronchiolitis (BQ) is the acute viral infection of the tract respiratory syndrome in infants
      that affects the bronchioles of babies under 24 months of age. Respiratory physiotherapy (RF)
      appears as a treatment measure complementary in the clinical guidelines and consensus on the
      management of the BQ.
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.

      The assignment will be made at the time of query according to a table of random numbers
      previously established and that it will only be known by physiotherapists.

      Before starting the treatment protocol, a blind evaluator who does not know the treatment to
      which the patient is assigned, classifies the child according to the initial score of
      clinical severity proposed by Wang, in addition to the measurement of SO2 and frequency heart
      rate through a pulse oximeter. The measurement of the amount of sputum collected in a meter
      measuring cup, once the respiratory physiotherapy session is finished, it will be done in a
      calibrated weight in both groups.

      The protocol in the manual maneuvers group consists of 20 minutes of FR based on prolonged
      slow expiration and coughing provoked. Is apassive technique of expiratory help applied to
      the baby through a slow thoracic-abdominal pressure that begins at the end of spontaneous
      expiration and continues to the residual volume. The physiotherapist through the cough
      provoked or stimulation of the trachea gets expectoration of sputum, to be able to assess its
      weight.

      The protocol in the high frequency compression chest wall group consists of the same protocol
      as the respiratory physiotherapy Group plus high frequency compression chest wall applied
      with Smart Vest® device, with a fixed frequency of 13 Hz and a time 15 min. The selected mode
      will be the normal (fixed parameters) and the pressure of 4 units (12 cm H2O). The patient
      remains seated on his parents, and with a cotton garment between the vest and the skin of the
      patient to prevent skin lesions.

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

      Criteria for cessation of physiotherapeutic intervention, alterations will be considered
      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
      manifestations clinics, it is established that if the parent or legal guardian so requires,
      the the application of the protocol.

      After 10 and 20 minutes of finishing both groups, the doctor again makes a measurement of
      mucus volume, SO2, heart and respiratory rate, and classify again according to the criteria
      of Wang's clinical severity scale.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single-blind controlled clinical trial
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).
measure: Heart rate
time frame: 12 weeks
description: Measured by a pulse oximeter (Radical 7 Touchscreen by Massimo®, Masimo Corporation, Irvine, CA).
measure: Amount of sputum
time frame: 12 weeks
description: The measurement of the amount of sputum collected in a metric measuring cup, once the session is finished, will be done in a calibrated weight
arm group label: Manual maneuvers physiotherapy
arm group type: Active Comparator
description: The protocol of physiotherapy treatment techniques consists of 20 minutes of FR based on prolonged slow expiration and cough provoked.
arm group label: High frequency compression chest wall
arm group type: Experimental
description: The protocol consists in the application of the Smart Vest® device for high frequency compression of the chest wall, with a fixed frequency of 13 Hz and a time of 15 minutes. Then during 20 minutes will apply the same protocol as in the manual maneuvers group.
intervention type: Other
intervention name: High frequency compression of the chest wall group
description: The protocol in the high frequency compression of the chest wall group device consists of the Smart Vest® application, with a fixed frequency of 13 Hz and a time of 15 minutes. The selected mode will be the normal (fixed parameters) and the pressure of 4 units (12 cm H2O). The patient remains seated on his parents, and with a cotton garment between the vest and the skin of the patient to prevent skin lesions.
arm group label: High frequency compression chest wall
intervention type: Other
intervention name: Manual maneuvers physiotherapy group
description: 20 minutes of manual maneuvers physiotherapy based on prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of spontaneous expiration and continues to the residual volume. The physiotherapist through the cough provoked or stimulation of the trachea gets expectoration of sputum, to be able to assess its weight.
arm group label: High frequency compression chest wall
arm group label: Manual maneuvers 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