<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/NCT04506203</url>
  </required_header>
  <id_info>
    <org_study_id>HULaPaz</org_study_id>
    <nct_id>NCT04506203</nct_id>
  </id_info>
  <brief_title>The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool</brief_title>
  <official_title>The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool: a Multi-centre Prospective Double-blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario La Paz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario La Princesa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Privado de Comunidad</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitario La Paz</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>
      HYPOTHESIS:&#xD;
&#xD;
      During anesthetic pre-oxygenation with high FiO2, pulmonary atelectasis occur, especially in&#xD;
      patients &lt; 6 years old, where FRC and pulmonary closing volume may overlap. New borns and&#xD;
      children &lt;1 year old are especially vulnerable.&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
        1. Validate &quot;air test&quot; as a individualized and non-invasive diagnostic method of clinically&#xD;
           significant atelectasis in pediatrics.&#xD;
&#xD;
        2. Determine what other factors contribute to atelectasis development in pediatrics&#xD;
&#xD;
      METHODS:&#xD;
&#xD;
      30 pediatric patients will be studied with ages ranged between 45 postconceptional weeks&#xD;
      and16 years old.&#xD;
&#xD;
      Baseline SpO2 and lung ultrasound will be performed for each patient upon arrival at the&#xD;
      operating theatre before preoxygenation with FiO2 of 1.0 SpO2 will be measured 15 min after&#xD;
      intubation during a 5 min long &quot;air test&quot; trial (FiO2 0.25). lung collapse will be verified&#xD;
      by lung ultrasound at the end of the 15 min trial. Lung collapse will be eventually granted&#xD;
      upon lung US verification by a blind researcher.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2020</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Lung Collapse will be diagnosed by a blind researcher that does not know the air test results</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Atelectasis incidence</measure>
    <time_frame>5 minutes</time_frame>
    <description>Assess incidence of SpO2 &lt; 97% 15 minutes after anesthesia induction during a 5 minutes long air test (FiO2 &lt; 0.25).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy of Pediatric Air test trial</measure>
    <time_frame>5 minutes</time_frame>
    <description>Assess incidence of lung collapse (hence atelectasis incidence) 15 minutes after anesthesia induction using an air test (FiO2 &lt; 0.25). Collapse blind validation using lung US</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Atelectasis risk factors assessment</measure>
    <time_frame>5 minutes</time_frame>
    <description>Determine if there occurs higher atelectasis incidence depending on age, sex, medical records, body weight index or type of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atelectasis severity</measure>
    <time_frame>5 minutes</time_frame>
    <description>Determine if there is any correlation between SpO2 values during air test and lung collapse, graded upon a validated severity lung collapse image score</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Lung Collapse</condition>
  <condition>Lung Diseases</condition>
  <condition>Atelectasis</condition>
  <condition>Atelectasis Without Respiratory Distress Syndrome</condition>
  <condition>Atelectases, Resorption</condition>
  <condition>Air Test</condition>
  <condition>Pediatric Disorder</condition>
  <arm_group>
    <arm_group_label>Air test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Air test</intervention_name>
    <description>Patients will breathe 0.21 &lt; FiO2 &lt; 0.25 during 5 min and have a lung ultrasound perfomed at the end of the 5 min trial.</description>
    <arm_group_label>Air test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General anesthesia&#xD;
&#xD;
          -  Perioperative risk classification (ASA) I, II, III&#xD;
&#xD;
          -  Newborns (postconceptional age&gt; 45 weeks) to 16 years&#xD;
&#xD;
          -  Need for oral / nasotracheal intubation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA &gt; III&#xD;
&#xD;
          -  Basal SpO2 &lt; 97% on air in supine position&#xD;
&#xD;
          -  Preoperative need for oxygen therapy and / or high-flow nasal cannulas&#xD;
&#xD;
          -  Expected Difficult airway&#xD;
&#xD;
          -  Presence of craniofacial disorders that may compromise ventilation&#xD;
&#xD;
          -  Hemodynamic instability and / or need for inotropics&#xD;
&#xD;
          -  History of untreated heart disease&#xD;
&#xD;
          -  Presence or history of pneumothorax&#xD;
&#xD;
          -  Presence of untreated congenital pulmonary disorders&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Weeks</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Privado de Comunidad</name>
      <address>
        <city>Córdoba</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Princesa</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario La Paz</investigator_affiliation>
    <investigator_full_name>Patricio Gonzalez Pizarro</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>air test</keyword>
  <keyword>atelectasis</keyword>
  <keyword>pediatric</keyword>
  <keyword>non-invasive</keyword>
  <keyword>lung collapse</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Pulmonary Atelectasis</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be published in a peer reviewed journal</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Upon publishment in journal</ipd_time_frame>
  </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/NCT04506203
org study id: HULaPaz
nct id: NCT04506203
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
HYPOTHESIS:

      During anesthetic pre-oxygenation with high FiO2, pulmonary atelectasis occur, especially in
      patients < 6 years old, where FRC and pulmonary closing volume may overlap. New borns and
      children <1 year old are especially vulnerable.

      OBJECTIVES:

        1. Validate "air test" as a individualized and non-invasive diagnostic method of clinically
           significant atelectasis in pediatrics.

        2. Determine what other factors contribute to atelectasis development in pediatrics

      METHODS:

      30 pediatric patients will be studied with ages ranged between 45 postconceptional weeks
      and16 years old.

      Baseline SpO2 and lung ultrasound will be performed for each patient upon arrival at the
      operating theatre before preoxygenation with FiO2 of 1.0 SpO2 will be measured 15 min after
      intubation during a 5 min long "air test" trial (FiO2 0.25). lung collapse will be verified
      by lung ultrasound at the end of the 15 min trial. Lung collapse will be eventually granted
      upon lung US verification by a blind researcher.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
masking description: Lung Collapse will be diagnosed by a blind researcher that does not know the air test results
measure: Atelectasis incidence
time frame: 5 minutes
description: Assess incidence of SpO2 < 97% 15 minutes after anesthesia induction during a 5 minutes long air test (FiO2 < 0.25).
measure: Accuracy of Pediatric Air test trial
time frame: 5 minutes
description: Assess incidence of lung collapse (hence atelectasis incidence) 15 minutes after anesthesia induction using an air test (FiO2 < 0.25). Collapse blind validation using lung US
measure: Atelectasis risk factors assessment
time frame: 5 minutes
description: Determine if there occurs higher atelectasis incidence depending on age, sex, medical records, body weight index or type of surgery
measure: Atelectasis severity
time frame: 5 minutes
description: Determine if there is any correlation between SpO2 values during air test and lung collapse, graded upon a validated severity lung collapse image score
arm group label: Air test
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: Air test
description: Patients will breathe 0.21 < FiO2 < 0.25 during 5 min and have a lung ultrasound perfomed at the end of the 5 min trial.
arm group label: Air test
criteria: 
gender: All
minimum age: 5 Weeks
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: Argentina
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario La Paz
investigator full name: Patricio Gonzalez Pizarro
investigator title: MD, PhD
mesh term: Lung Diseases
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Pulmonary Atelectasis
mesh term: Shock
sharing ipd: Yes
ipd description: IPD will be published in a peer reviewed journal
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Upon publishment in journal