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/NCT06042036</url>
    </required_header>
    <id_info>
      <org_study_id>28482720.0.1001.0068</org_study_id>
      <nct_id>NCT06042036</nct_id>
    </id_info>
    <brief_title>Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation in Patients With Acute Respiratory Failure</brief_title>
    <acronym>SPIRAL</acronym>
    <official_title>Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation Mode in Patients With Acute Respiratory Failure in ICUs in Latin America</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Sao Paulo General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Brazilian Research In Intensive Care Network</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Liven</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Sao Paulo General Hospital</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 observational study is to estimate the prevalence of the use of protective&#xD;
        ventilation with low tidal volume ventilation in the transition of spontaneous ventilation&#xD;
        modes in patients with hypoxemic acute respiratory failure in ICUs in Latin America&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  what is the prevalence of the use of low tidal volume ventilation (VT &lt;8 mL/kg of&#xD;
             predicted body weight) in the first 24 hours of spontaneous ventilation modes in&#xD;
             patients with hypoxemic acute respiratory failure?&#xD;
  &#xD;
          -  Is there an association between the rate of adherence to low tidal volume ventilation in&#xD;
             spontaneous ventilation modes and mortality?&#xD;
  &#xD;
        Participants are patients with acute respiratory failure under mechanical ventilation.&#xD;
        Investigators will collect data on the ventilatory parameters of participants&#xD;
  &#xD;
          -  24 hours before they begin to be ventilated with spontaneous modes of ventilation&#xD;
  &#xD;
          -  during the first 24 hours of spontaneous ventilation&#xD;
  &#xD;
        Investigators will collect several patient-centered clinical outcomes at 28 days after study&#xD;
        inclusion, including ventilator-free days and mortality&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Investigators will conduct a cohort study in Intensive Care Units (ICUs) across Latin&#xD;
        America, aiming to include 422 patients with Hypoxemic Acute Respiratory Failure (ARF) and&#xD;
        under invasive mechanical ventilation.&#xD;
  &#xD;
        The goal of this observational study is to estimate the prevalence of the use of protective&#xD;
        ventilation with low tidal volume ventilation in the transition of spontaneous ventilation&#xD;
        modes in patients with hypoxemic acute respiratory failure in ICUs in Latin America&#xD;
  &#xD;
        The primary objective is to determine the prevalence of low tidal volume ventilation (VT &lt; 8&#xD;
        mL/kg of predicted body weight) during the initial 24 hours of spontaneous ventilatory modes&#xD;
        in patients diagnosed with hypoxemic ARF. Investigators are primarily interested in assessing&#xD;
        the rate of adherence to low tidal volume ventilation, defined as maintaining VT &lt; 8 mL/kg of&#xD;
        predicted body weight during the first 24 hours of ventilation in spontaneous mode.&#xD;
  &#xD;
        Investigators will also measure the proportion of patients experiencing significant&#xD;
        asynchrony during the transition to spontaneous mechanical ventilation, who revert to&#xD;
        sedation and controlled mechanical ventilation within the first 24 hours or at any point&#xD;
        during mechanical ventilation. Finally, 28-day hospital survival will be measured&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 12, 2023</start_date>
    <completion_date type="Anticipated">October 12, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 12, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Low tidal volume</measure>
      <time_frame>24 hours</time_frame>
      <description>Low tidal volume, defined as less or equal to 8 mLs per Kg of predicted body weight</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>28 days</time_frame>
      <description>mortality in the hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Asynchrony</measure>
      <time_frame>24 hours</time_frame>
      <description>presence of patient asynchrony 24h after transition to a spontaneous mode of mechanical ventilation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to controlled mechanical ventilation in the first 24 hours</measure>
      <time_frame>24 hours</time_frame>
      <description>return to controlled mechanical ventilation in the first 24 hours after transition to spontaneous ventilation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to sedation in the first 24 hours</measure>
      <time_frame>24 hours</time_frame>
      <description>return to sedation in the first 24 hours after transition to spontaneous ventilation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to controlled mechanical ventilation after transition to spontaneous ventilation</measure>
      <time_frame>28 days</time_frame>
      <description>return to controlled mechanical ventilation any time after transition to spontaneous ventilation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to sedation after transition to spontaneous ventilation</measure>
      <time_frame>28 days</time_frame>
      <description>return to sedation any time after transition to spontaneous ventilation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ventilator- free days</measure>
      <time_frame>28 days</time_frame>
      <description>number of days alive and not receiving invasive mechanical ventilation after transition to spontaneous ventilation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adherence to PEEP/FIO2 table</measure>
      <time_frame>24 hours</time_frame>
      <description>adherence to ARDSnet low PEEP/FIO2 table after transition to spontaneous ventilation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Extubation</measure>
      <time_frame>28 days</time_frame>
      <description>Extubation after transition to spontaneous mode</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reintubation</measure>
      <time_frame>28 days</time_frame>
      <description>Reintubation after transition to spontaneous mode and extubation</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">422</enrollment>
    <condition>Respiration, Artificial</condition>
    <condition>Acute Hypoxemic Respiratory Failure</condition>
    <condition>Respiratory Insufficiency</condition>
    <arm_group>
      <arm_group_label>acute hypoxemic respiratory failure</arm_group_label>
      <description>Patients with acute hypoxemic respiratory failure transitioning to a spontaneous mode of mechanical ventilation ( PSV, APRV, NAVA, PAV+, CPAP)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Spontaneous mode of mechanical ventilation</intervention_name>
      <description>any mode of mechanical ventilation classified as spontaneous or proportional, mainly pressure support ventilation, but also CPAP, APRV, NAVA, PAV+</description>
      <arm_group_label>acute hypoxemic respiratory failure</arm_group_label>
      <other_name>spontaneous ventilation</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with hypoxemic ARF, defined as a PaO2/FIO2 ratio &lt;300 mmHg, under controlled&#xD;
          invasive mechanical ventilation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; 18 years&#xD;
  &#xD;
            -  Patients with hypoxemic ARF, defined as a PaO2/FIO2 ratio &lt;300 mmHg, under controlled&#xD;
               invasive mechanical ventilation, with an expected duration of MV of at least 24h.&#xD;
  &#xD;
            -  Patients transitioning to spontaneous ventilation modes (PSV, PAV Plus, NAVA or APRV)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Tracheostomized patients.&#xD;
  &#xD;
            -  Decision not to maintain or add life support measures on the day of assessment&#xD;
               (palliative care).&#xD;
  &#xD;
            -  Patient in ECMO.&#xD;
  &#xD;
            -  Air fistula or barotrauma that prevents adequate tidal volume monitoring.&#xD;
  &#xD;
            -  Severe injuries to the central nervous system that result in abolished or very high&#xD;
               respiratory drive, for whom it is not possible to maintain protective tidal volume.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>110 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>JULIANA C FERREIRA, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Sao Paulo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fabia D Silva, PhD</last_name>
      <phone>34992484248</phone>
      <email>fabiadiniz@usp.br</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Juliana C FERREIRA, MD</last_name>
      <phone>11983355876</phone>
      <email>juliana.ferreira@hc.fm.usp.br</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Sanatorio Juncal SA</name>
        <address>
          <city>Buenos Aires</city>
          <country>Argentina</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pablo Gomez</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Municipal Boliviano Holandés, Universidad Mayor de San Andrés</name>
        <address>
          <city>La Paz</city>
          <country>Bolivia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Adrian Avilla</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital das Clínicas -HCFMUSP</name>
        <address>
          <city>Sao Paulo</city>
          <state>SP</state>
          <zip>05403010</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Juliana C Ferreira, MD</last_name>
        <phone>+5511983355876</phone>
      </contact>
      <investigator>
        <last_name>juliana ferreira, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Pontificia Universidad Catolica de Chile</name>
        <address>
          <city>Santiago</city>
          <country>Chile</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Alejandro Bruhn</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Clinica Universidad de la Sabana</name>
        <address>
          <city>Chía</city>
          <country>Colombia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Luis Felipe Reyes</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Eugenio Espejo</name>
        <address>
          <city>Quito</city>
          <country>Ecuador</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Manuel Jibaja</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Civil Fray Antonio Alcalde</name>
        <address>
          <city>Guadalajara</city>
          <country>Mexico</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Miguel Ibarra</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital San Roque</name>
        <address>
          <city>Asunción</city>
          <country>Paraguay</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gabriel Preda</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Rebagliati</name>
        <address>
          <city>Lima</city>
          <country>Peru</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rollin Roldan</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Espanol</name>
        <address>
          <city>Montevideo</city>
          <country>Uruguay</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nicolas Nin</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Argentina</country>
      <country>Bolivia</country>
      <country>Brazil</country>
      <country>Chile</country>
      <country>Colombia</country>
      <country>Ecuador</country>
      <country>Mexico</country>
      <country>Paraguay</country>
      <country>Peru</country>
      <country>Uruguay</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Adherence, Treatment</keyword>
    <keyword>intensive care units</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>data sharing will follow Institutional rules for patient data protection</ipd_description>
    </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/NCT06042036
  org study id: 28482720.0.1001.0068
  nct id: NCT06042036
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to estimate the prevalence of the use of protective
        ventilation with low tidal volume ventilation in the transition of spontaneous ventilation
        modes in patients with hypoxemic acute respiratory failure in ICUs in Latin America
  
        The main questions it aims to answer are:
  
          -  what is the prevalence of the use of low tidal volume ventilation (VT <8 mL/kg of
             predicted body weight) in the first 24 hours of spontaneous ventilation modes in
             patients with hypoxemic acute respiratory failure?
  
          -  Is there an association between the rate of adherence to low tidal volume ventilation in
             spontaneous ventilation modes and mortality?
  
        Participants are patients with acute respiratory failure under mechanical ventilation.
        Investigators will collect data on the ventilatory parameters of participants
  
          -  24 hours before they begin to be ventilated with spontaneous modes of ventilation
  
          -  during the first 24 hours of spontaneous ventilation
  
        Investigators will collect several patient-centered clinical outcomes at 28 days after study
        inclusion, including ventilator-free days and mortality
  Investigators will conduct a cohort study in Intensive Care Units (ICUs) across Latin
        America, aiming to include 422 patients with Hypoxemic Acute Respiratory Failure (ARF) and
        under invasive mechanical ventilation.
  
        The goal of this observational study is to estimate the prevalence of the use of protective
        ventilation with low tidal volume ventilation in the transition of spontaneous ventilation
        modes in patients with hypoxemic acute respiratory failure in ICUs in Latin America
  
        The primary objective is to determine the prevalence of low tidal volume ventilation (VT < 8
        mL/kg of predicted body weight) during the initial 24 hours of spontaneous ventilatory modes
        in patients diagnosed with hypoxemic ARF. Investigators are primarily interested in assessing
        the rate of adherence to low tidal volume ventilation, defined as maintaining VT < 8 mL/kg of
        predicted body weight during the first 24 hours of ventilation in spontaneous mode.
  
        Investigators will also measure the proportion of patients experiencing significant
        asynchrony during the transition to spontaneous mechanical ventilation, who revert to
        sedation and controlled mechanical ventilation within the first 24 hours or at any point
        during mechanical ventilation. Finally, 28-day hospital survival will be measured
  observational model: Cohort
  time perspective: Prospective
  measure: Low tidal volume
  time frame: 24 hours
  description: Low tidal volume, defined as less or equal to 8 mLs per Kg of predicted body weight
  measure: Mortality
  time frame: 28 days
  description: mortality in the hospital
  measure: Asynchrony
  time frame: 24 hours
  description: presence of patient asynchrony 24h after transition to a spontaneous mode of mechanical ventilation
  measure: Return to controlled mechanical ventilation in the first 24 hours
  time frame: 24 hours
  description: return to controlled mechanical ventilation in the first 24 hours after transition to spontaneous ventilation
  measure: Return to sedation in the first 24 hours
  time frame: 24 hours
  description: return to sedation in the first 24 hours after transition to spontaneous ventilation
  measure: Return to controlled mechanical ventilation after transition to spontaneous ventilation
  time frame: 28 days
  description: return to controlled mechanical ventilation any time after transition to spontaneous ventilation
  measure: Return to sedation after transition to spontaneous ventilation
  time frame: 28 days
  description: return to sedation any time after transition to spontaneous ventilation
  measure: Ventilator- free days
  time frame: 28 days
  description: number of days alive and not receiving invasive mechanical ventilation after transition to spontaneous ventilation
  measure: Adherence to PEEP/FIO2 table
  time frame: 24 hours
  description: adherence to ARDSnet low PEEP/FIO2 table after transition to spontaneous ventilation
  measure: Extubation
  time frame: 28 days
  description: Extubation after transition to spontaneous mode
  measure: Reintubation
  time frame: 28 days
  description: Reintubation after transition to spontaneous mode and extubation
  arm group label: acute hypoxemic respiratory failure
  description: Patients with acute hypoxemic respiratory failure transitioning to a spontaneous mode of mechanical ventilation ( PSV, APRV, NAVA, PAV+, CPAP)
  intervention type: Other
  intervention name: Spontaneous mode of mechanical ventilation
  description: any mode of mechanical ventilation classified as spontaneous or proportional, mainly pressure support ventilation, but also CPAP, APRV, NAVA, PAV+
  arm group label: acute hypoxemic respiratory failure
  other name: spontaneous ventilation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 110 Years
  healthy volunteers: No
  last name: JULIANA C FERREIRA, MD
  role: Principal Investigator
  affiliation: University of Sao Paulo
  last name: Fabia D Silva, PhD
  phone: 34992484248
  email: fabiadiniz@usp.br
  last name: Juliana C FERREIRA, MD
  phone: 11983355876
  email: juliana.ferreira@hc.fm.usp.br
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Argentina
  country: Bolivia
  country: Brazil
  country: Chile
  country: Colombia
  country: Ecuador
  country: Mexico
  country: Paraguay
  country: Peru
  country: Uruguay
  responsible party type: Sponsor
  mesh term: Respiratory Insufficiency
  sharing ipd: Undecided
  ipd description: data sharing will follow Institutional rules for patient data protection