<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/NCT01726140</url>
  </required_header>
  <id_info>
    <org_study_id>CRHACS CEI-457</org_study_id>
    <nct_id>NCT01726140</nct_id>
  </id_info>
  <brief_title>CPAP Reduces Hypoxemia After Cardiac Surgery</brief_title>
  <acronym>CRHACS</acronym>
  <official_title>CPAP Reduces Hypoxemia After Cardiac Surgery (CRHACS Trial). A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agenzia Italiana del Farmaco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Turin, Italy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of study is to evaluate whether the application of a continuous positive airway&#xD;
      pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia&#xD;
      and re-intubation rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We want to test the hypothesis that the application of a continuous positive airway pressure&#xD;
      (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and&#xD;
      re-intubation rate.&#xD;
&#xD;
      Primary end point: to reduce the rate of re-intubation.&#xD;
&#xD;
      Secondary end point: to reduce the incidence of atelectasis, pneumonia, sepsis, the mortality&#xD;
      rate, the intensive care unit (ICU) and hospital length of stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>rate of re-intubation</measure>
    <time_frame>at 28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of atelectasis</measure>
    <time_frame>at 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of pneumonia</measure>
    <time_frame>at 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of sepsis</measure>
    <time_frame>at 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality rate</measure>
    <time_frame>at 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the intensive care unit length of stay</measure>
    <time_frame>at 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital length of stay</measure>
    <time_frame>at 28 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">960</enrollment>
  <condition>Acute Respiratory Failure Requiring Reintubation</condition>
  <arm_group>
    <arm_group_label>TREATMENT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Helmet CPAP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Venturi Mask</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Helmet CPAP</intervention_name>
    <description>the patient will receive CPAP treatment, at a PEEP level of 10 cmH2O and a FiO2 adjusted to maintain SpO2&gt;95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will repeat a spontaneous breathing trial with a Venturi mask at FiO2 = 50%, for 15 minutes and than a blood gas analysis will be repeated: if the PaO2/FiO2 will be &lt; 200 the patient will received a second treatment with CPAP; if PaO2/FiO2 will be &gt;200, the patient will stop the treatment.</description>
    <arm_group_label>TREATMENT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Venturi Mask</intervention_name>
    <description>the patient will maintain spontaneous breathing, with a system for oxygen delivery at a FiO2 adjusted to maintain SpO2&gt;95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will do a trial for 15 minutes and after that a blood gas analysis will be repeated: if the PaO2/FiO2 will be &lt; 200 the patient will go on with the control treatment; if PaO2 /FiO2 will be &gt;200, the patient will stop the treatment.</description>
    <arm_group_label>CONTROL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing cardiac surgery on cardiopulmonary bypass&#xD;
&#xD;
          -  PaO2 /FiO2 &lt; 200 after extubation&#xD;
&#xD;
          -  extubation time &lt; 24 h.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients &lt; 18 years old&#xD;
&#xD;
          -  extracorporeal membrane oxygenation&#xD;
&#xD;
          -  severe cardiac dysfunction (FE&lt;25%)&#xD;
&#xD;
          -  mechanical ventilation before the intervention&#xD;
&#xD;
          -  severe COPD (patients on oxygen therapy, with a FEV1&lt; 50%)&#xD;
&#xD;
          -  heart or lung transplantation&#xD;
&#xD;
          -  lack of consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vito Marco VM Ranieri, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Turin, Italy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Daniela Pasero, MD</last_name>
    <phone>+390116336129</phone>
    <email>daniela.pasero@unito.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claudia Filippini, PhD</last_name>
    <phone>+390116336140</phone>
    <email>claudia.filippini@unito.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Turin - Department of Anesthesia and Intensive Care Medicine</name>
      <address>
        <city>Turin</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniela Pasero, MD</last_name>
      <phone>+390116336129</phone>
      <email>daniela.pasero@unito.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>July 10, 2017</last_update_submitted>
  <last_update_submitted_qc>July 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turin, Italy</investigator_affiliation>
    <investigator_full_name>Daniela Pasero</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>intubation</keyword>
  <keyword>respiratory failure</keyword>
  <keyword>cardiac surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Hypoxia</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/NCT01726140
org study id: CRHACS CEI-457
nct id: NCT01726140
lead sponsor: 
collaborator: 
has dmc: No
The aim of study is to evaluate whether the application of a continuous positive airway
      pressure (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia
      and re-intubation rate.
We want to test the hypothesis that the application of a continuous positive airway pressure
      (CPAP) after extubation in patients undergoing cardiac surgery can reduce hypoxemia and
      re-intubation rate.

      Primary end point: to reduce the rate of re-intubation.

      Secondary end point: to reduce the incidence of atelectasis, pneumonia, sepsis, the mortality
      rate, the intensive care unit (ICU) and hospital length of stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: rate of re-intubation
time frame: at 28 days
measure: incidence of atelectasis
time frame: at 28 days
measure: incidence of pneumonia
time frame: at 28 days
measure: incidence of sepsis
time frame: at 28 days
measure: mortality rate
time frame: at 28 days
measure: the intensive care unit length of stay
time frame: at 28 days
measure: hospital length of stay
time frame: at 28 days
arm group label: TREATMENT
arm group type: Experimental
description: Helmet CPAP
arm group label: CONTROL
arm group type: Active Comparator
description: Venturi Mask
intervention type: Procedure
intervention name: Helmet CPAP
description: the patient will receive CPAP treatment, at a PEEP level of 10 cmH2O and a FiO2 adjusted to maintain SpO2>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will repeat a spontaneous breathing trial with a Venturi mask at FiO2 = 50%, for 15 minutes and than a blood gas analysis will be repeated: if the PaO2/FiO2 will be < 200 the patient will received a second treatment with CPAP; if PaO2/FiO2 will be >200, the patient will stop the treatment.
arm group label: TREATMENT
intervention type: Procedure
intervention name: Venturi Mask
description: the patient will maintain spontaneous breathing, with a system for oxygen delivery at a FiO2 adjusted to maintain SpO2>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will do a trial for 15 minutes and after that a blood gas analysis will be repeated: if the PaO2/FiO2 will be < 200 the patient will go on with the control treatment; if PaO2 /FiO2 will be >200, the patient will stop the treatment.
arm group label: CONTROL
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vito Marco VM Ranieri, MD
role: Study Chair
affiliation: University of Turin, Italy
last name: Daniela Pasero, MD
phone: +390116336129
email: daniela.pasero@unito.it
last name: Claudia Filippini, PhD
phone: +390116336140
email: claudia.filippini@unito.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Turin, Italy
investigator full name: Daniela Pasero
investigator title: Principal Investigator
mesh term: Respiratory Insufficiency
mesh term: Hypoxia