<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/NCT03279887</url>
  </required_header>
  <id_info>
    <org_study_id>ECHOVAP</org_study_id>
    <nct_id>NCT03279887</nct_id>
  </id_info>
  <brief_title>Lung Ultrasonography After Major Cardiac Surgery</brief_title>
  <acronym>ECHOVAP</acronym>
  <official_title>Usefulness of Lung Ultrasonography for Diagnosis of Pneumonia After Major Cardiac Surgery: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Hospitalier Pitie-Salpetriere</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe Hospitalier Pitie-Salpetriere</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>
      Diagnosis of pneumonia remains difficult in intensive care unit (ICU), notably after cardiac&#xD;
      surgery. Lung ultrasonography (LUS) has been successfully used for diagnosis of pneumonia,&#xD;
      but its usefulness and reliability was never evaluated after cardiac surgery. This study&#xD;
      investigates the clinical relevance of LUS for pneumonia diagnoses in cardiac ICU.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Final diagnosis of pneumonia</measure>
    <time_frame>During the 72 hours following surgery</time_frame>
    <description>Pneumonia or excluded pneumonia, was determined by consensus of 3 investigators, after an independent post hoc review of the medical records. Pneumonia diagnosis was based on concordance of clinical and radiological criteria (≥ 2 criteria including fever&gt; 38.5 ° C or T &lt;36 ° C, leukocytosis&gt; 10 ^ 9 / L or leukopenia &lt;4.10 ^ 8 / L, purulent tracheal secretions and the appearance or persistence of an infiltrate on the CXR).&#xD;
It should be confirmed by culture of a respiratory specimen: protected distal sampling with a threshold of significance ≥ 10 ^ 3 colony forming unit/mL or bronchoalveolar lavage with a threshold of significance ≥ 10 ^ 4 CFU/mL.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">51</enrollment>
  <condition>Pneumonia</condition>
  <condition>Cardio/Pulm: Respiratory Failure</condition>
  <condition>Cardiopulmonary Bypass</condition>
  <arm_group>
    <arm_group_label>Post operative respiratory failure</arm_group_label>
    <description>Patients with acute respiratory failure (ARF) less than 72 hours after a major cardiac surgery with cardiopulmonary bypass&#xD;
ARF was defined as one of the following conditions:&#xD;
If mechanical ventilation, a partial pressure of oxygen/ inspired oxygen fraction ratio (PaO2/FiO2) &lt; 200, or failure of weaning (failure of spontaneous ventilation test, re-intubation in the first 24 hours), or need for non-invasive ventilation immediately after extubation,&#xD;
If spontaneous ventilation: clinical signs of acute respiratory distress (dyspnea at least exertion, cyanosis, polypnea&gt; 25/min, upper or intercostal swallowing, abdominal swing ...), pulse oximetry (SpO2) &lt; 90% or PaO2 &lt;60 mmHg despite oxygen therapy ≥ 3 L/min.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lung Ultrasound</intervention_name>
    <arm_group_label>Post operative respiratory failure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with acute respiratory failure after cardiac surgery and hospitalized in the&#xD;
        surgical Intensive Care Unit of ICU of Cardiology Institute, Pitié Salpêtrière University&#xD;
        Hospital, Paris, France&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cardiac surgery with sternotomy and cardio-pulmonary bypass (CPB) less than 3 days&#xD;
             before&#xD;
&#xD;
          -  At least one component suggestive of ARF:&#xD;
&#xD;
               -  If mechanical ventilation, a PaO2 / FiO2 ratio &lt;200, or failure of weaning&#xD;
                  (failure of spontaneous ventilation test, re-intubation in the first 24 hours),&#xD;
                  or need for non-invasive ventilation immediately after extubation,&#xD;
&#xD;
               -  If spontaneous ventilation: clinical signs of acute respiratory distress (dyspnea&#xD;
                  at least exertion, cyanosis, polypnea&gt; 25/min, upper or intercostal swallowing,&#xD;
                  abdominal swing ...), SpO2 &lt; 90% or PaO2 &lt;60 mmHg despite oxygen therapy ≥&#xD;
                  3L/min.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patients&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Sleep apnea syndrome&#xD;
&#xD;
          -  Participation refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</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 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Groupe Hospitalier Pitie-Salpetriere</investigator_affiliation>
    <investigator_full_name>Adrien Bouglé</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03279887
org study id: ECHOVAP
nct id: NCT03279887
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Diagnosis of pneumonia remains difficult in intensive care unit (ICU), notably after cardiac
      surgery. Lung ultrasonography (LUS) has been successfully used for diagnosis of pneumonia,
      but its usefulness and reliability was never evaluated after cardiac surgery. This study
      investigates the clinical relevance of LUS for pneumonia diagnoses in cardiac ICU.
observational model: Cohort
time perspective: Prospective
measure: Final diagnosis of pneumonia
time frame: During the 72 hours following surgery
description: Pneumonia or excluded pneumonia, was determined by consensus of 3 investigators, after an independent post hoc review of the medical records. Pneumonia diagnosis was based on concordance of clinical and radiological criteria (≥ 2 criteria including fever> 38.5 ° C or T <36 ° C, leukocytosis> 10 ^ 9 / L or leukopenia <4.10 ^ 8 / L, purulent tracheal secretions and the appearance or persistence of an infiltrate on the CXR).
It should be confirmed by culture of a respiratory specimen: protected distal sampling with a threshold of significance ≥ 10 ^ 3 colony forming unit/mL or bronchoalveolar lavage with a threshold of significance ≥ 10 ^ 4 CFU/mL.
arm group label: Post operative respiratory failure
description: Patients with acute respiratory failure (ARF) less than 72 hours after a major cardiac surgery with cardiopulmonary bypass
ARF was defined as one of the following conditions:
If mechanical ventilation, a partial pressure of oxygen/ inspired oxygen fraction ratio (PaO2/FiO2) < 200, or failure of weaning (failure of spontaneous ventilation test, re-intubation in the first 24 hours), or need for non-invasive ventilation immediately after extubation,
If spontaneous ventilation: clinical signs of acute respiratory distress (dyspnea at least exertion, cyanosis, polypnea> 25/min, upper or intercostal swallowing, abdominal swing ...), pulse oximetry (SpO2) < 90% or PaO2 <60 mmHg despite oxygen therapy ≥ 3 L/min.
intervention type: Diagnostic Test
intervention name: Lung Ultrasound
arm group label: Post operative respiratory failure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Groupe Hospitalier Pitie-Salpetriere
investigator full name: Adrien Bouglé
investigator title: Principal Investigator
mesh term: Pneumonia
mesh term: Respiratory Insufficiency
sharing ipd: No