<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/NCT04448782</url>
  </required_header>
  <id_info>
    <org_study_id>RT COVID-19</org_study_id>
    <nct_id>NCT04448782</nct_id>
  </id_info>
  <brief_title>Characterization of Reverse Triggering and Other Asynchronies in COVID-19 Patients Under Invasive Mechanical Ventilation</brief_title>
  <official_title>Characterization of Reverse Triggering and Other Asynchronies in COVID-19 Patients Under Invasive Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corporacion Parc Tauli</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>
      Prospective observational trial in patients admitted to ICU diagnosed with COVID-19 requiring&#xD;
      invasive mechanical ventilation. Characterization of Reverse Triggering asynchrony during the&#xD;
      first 5 days of invasive mechanical ventilation and other asynchronies, and its correlation&#xD;
      with different outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 9, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Incidence and pattern of presentation of Reverse triggering in COVID-19 patients under invasive mechanical ventilation</measure>
    <time_frame>during the 5 first days of invasive mechanical ventilation</time_frame>
    <description>To analyze the incidence of Reverse Triggering in the initial phases of invasive mechanical ventilation in COVID-19 patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Reverse Triggering related to the level of sedation in COVID-19 patients under invasive mechanical ventilation</measure>
    <time_frame>From the day of mechanical ventilation initation up to 5 days or the last day of mechanical ventilation</time_frame>
    <description>To correlate the presence of Reverse Triggering with the level of sedation and use of neuromuscular blockers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reverse triggering and secondary asynchronies in COVID-19 patients under invasive mechanical ventilation</measure>
    <time_frame>From the day of mechanical ventilation initiation up to 5 days</time_frame>
    <description>To analyze the incidence of breath stacking and ineffective efforts secondary to RT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and pattern of presentation of asynchronies in COVID-19 patients under invasive mechanical ventilation</measure>
    <time_frame>Each day from the day of mechanical ventilation initiation until the day of mechanical ventilation withdrawal or up to 28 days</time_frame>
    <description>To analyze the incidence of RT, ineffective efforts and double triggering throughout the period of invasive mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of asynchronies in different outcomes in in COVID-19 patients under invasive mechanical ventilation</measure>
    <time_frame>Each day from the day of mechanical ventilation initiation until the end of invasive mechanical ventilation, ICU discharge and hospital discharge or up to 28 days</time_frame>
    <description>To correlate the presence of asycnhronies and its type with duration of invasive mechanical ventilation, ICU length of stay and survival</description>
  </secondary_outcome>
  <enrollment type="Actual">32</enrollment>
  <condition>Mechanical Ventilation Complication</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Asynchronies detection</intervention_name>
    <description>Asycnhronies detection</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients admitted to the ICU under invasive mechanical ventilation with ARDS&#xD;
        secondary to COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients under invasive mechanical ventilation more than 24 hours and with a minimum&#xD;
             of 48 hours of respiratory signals registered from the ventilator&#xD;
&#xD;
          -  Diagnosis of COVID-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 48 hours of data,&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  admitted from other centers under invasive mechanical ventilation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Candelaria de Haro</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Candelaria de Haro</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04448782
org study id: RT COVID-19
nct id: NCT04448782
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective observational trial in patients admitted to ICU diagnosed with COVID-19 requiring
      invasive mechanical ventilation. Characterization of Reverse Triggering asynchrony during the
      first 5 days of invasive mechanical ventilation and other asynchronies, and its correlation
      with different outcomes.
observational model: Cohort
time perspective: Prospective
measure: Incidence and pattern of presentation of Reverse triggering in COVID-19 patients under invasive mechanical ventilation
time frame: during the 5 first days of invasive mechanical ventilation
description: To analyze the incidence of Reverse Triggering in the initial phases of invasive mechanical ventilation in COVID-19 patients
measure: Incidence of Reverse Triggering related to the level of sedation in COVID-19 patients under invasive mechanical ventilation
time frame: From the day of mechanical ventilation initation up to 5 days or the last day of mechanical ventilation
description: To correlate the presence of Reverse Triggering with the level of sedation and use of neuromuscular blockers
measure: Reverse triggering and secondary asynchronies in COVID-19 patients under invasive mechanical ventilation
time frame: From the day of mechanical ventilation initiation up to 5 days
description: To analyze the incidence of breath stacking and ineffective efforts secondary to RT.
measure: Incidence and pattern of presentation of asynchronies in COVID-19 patients under invasive mechanical ventilation
time frame: Each day from the day of mechanical ventilation initiation until the day of mechanical ventilation withdrawal or up to 28 days
description: To analyze the incidence of RT, ineffective efforts and double triggering throughout the period of invasive mechanical ventilation
measure: Influence of asynchronies in different outcomes in in COVID-19 patients under invasive mechanical ventilation
time frame: Each day from the day of mechanical ventilation initiation until the end of invasive mechanical ventilation, ICU discharge and hospital discharge or up to 28 days
description: To correlate the presence of asycnhronies and its type with duration of invasive mechanical ventilation, ICU length of stay and survival
intervention type: Diagnostic Test
intervention name: Asynchronies detection
description: Asycnhronies detection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Candelaria de Haro
investigator title: Medical Doctor
sharing ipd: Undecided