<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/NCT02262182</url>
  </required_header>
  <id_info>
    <org_study_id>RC14_0033</org_study_id>
    <nct_id>NCT02262182</nct_id>
  </id_info>
  <brief_title>Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAP® After Cardiac Surgery in the Management of Postoperative Atelectasis</brief_title>
  <acronym>PEPKIN</acronym>
  <official_title>Evaluation of the Interest of Positive Expiratory Pressure (PEP) Delivery by EzPAP® Device Associated With Respiratory Physiotherapy in the Treatment of Postoperative Pulmonary Atelectasis in Patients After Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulmonary atelectasis is a frequent respiratory postoperative complication in cardiac&#xD;
      surgery. Classically, the treatment of these patients is based on manual chest physiotherapy.&#xD;
      Our objective is to evaluate the interest of association of positive end expiratory delivery&#xD;
      sessions with the EzPAP® device. We perform a prospective monocentric, open label trial.&#xD;
      Patients with atelectasis after scheduled cardiac surgery with cardiopulmonary bypass are&#xD;
      included. They benefit from manual chest therapy and are randomised to receive or not&#xD;
      positive end expiratory pressure sessions twice a day. The primary endpoint is the effect of&#xD;
      this treatment on atelectasis radiological score after 2 days of treatment. The secondary&#xD;
      endpoints are: oxygen saturation(SpO2)/inspired oxygen(FiO2) ratio, qualitative evaluation of&#xD;
      ventilatory function, respiratory &amp; cardiac rate, pain, inspiratory pressure (sniff test),&#xD;
      patient satisfaction, duration of intensive care unit (ICU) and hospital stay.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Radiological atelectasis score</measure>
    <time_frame>Day 2 post-inclusion</time_frame>
    <description>This score was first described by Pasquina P et al in 2004</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiological atelectasis score</measure>
    <time_frame>Days 1 and 3 post-inclusion</time_frame>
    <description>This score was first described by Pasquina P et al in 2004</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SpO2/FiO2 ratio</measure>
    <time_frame>Days 1, 2 and 3 post inclusion</time_frame>
    <description>This ratio is measured before and after session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac and respiratory rate</measure>
    <time_frame>Days 1, 2 and 3 post inclusion</time_frame>
    <description>Measurement performed at the same time as SPO2 (patients are monitored)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative evaluation of ventilatory function (nasal flaring, superficial tachypnea, use of accessory muscle, paradoxical abdominal respiration, cough difficulty) before and after session</measure>
    <time_frame>Days 1, 2 and 3 post inclusion</time_frame>
    <description>This respiratory function assessment is performed in a qualitative way</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea evaluation</measure>
    <time_frame>Days 1, 2 and 3 post inclusion</time_frame>
    <description>Dyspnea is measured with a visual analogue scale before and after session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain evaluation</measure>
    <time_frame>Days 1, 2 and 3 post inclusion</time_frame>
    <description>Pain is measured with a visual analogue scale before and after session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vesicular murmur intensity</measure>
    <time_frame>Days 1, 2 and 3 post inclusion</time_frame>
    <description>Vesicular murmur absent = 0, reduce = 1, present and normal = 2 Intensity is measured with an electronic stethoscope before and after session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inspiratory pressure measurement</measure>
    <time_frame>Days 2 and 3 post inclusion</time_frame>
    <description>This measurement (so called sniff test) is assessed with MicroRPM device before and after session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of patient satisfaction and tolerance of EzPAP device</measure>
    <time_frame>Day 3 post inclusion</time_frame>
    <description>A questionnaire of 10 answer with semi-quantitative scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Pulmonary Atelectasis</condition>
  <arm_group>
    <arm_group_label>KP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PEP delivery by EzPAP® device with manual chest physiotherapy .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KM group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Manual chest physiotherapy only;</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>KP group</intervention_name>
    <arm_group_label>KP group</arm_group_label>
    <other_name>Associated to manual chest physiotherapy, patients receive twice a day 4 periods of PEP delivery by EzPAP® device during 25 respiratory cycles.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>KM group</intervention_name>
    <arm_group_label>KM group</arm_group_label>
    <other_name>Patients of the control group benefit only from manual chest physiotherapy twice a day</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted in ICU after cardiac surgery by sternotomy with cardiopulmonary&#xD;
             bypass presenting a pulmonary atelectasis after extubation, diagnosed by chest X-ray&#xD;
             in postoperative period (day1 to day 2).&#xD;
&#xD;
          -  Patients over 18 years of age&#xD;
&#xD;
          -  Informed patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac arrhythmia&#xD;
&#xD;
          -  Hemodynamic instability (mean blood pressure &lt; 65 mmHg or &gt; 95 mmHg)&#xD;
&#xD;
          -  Respiratory rate &gt; 35/min&#xD;
&#xD;
          -  Undrained pneumothorax&#xD;
&#xD;
          -  Predictable trachea intubation or emergent surgery&#xD;
&#xD;
          -  Patient oral refusal&#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>Nantes Universitary Hospital</name>
      <address>
        <city>St-Herblain</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>September 28, 2016</last_update_submitted>
  <last_update_submitted_qc>September 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atelectasis, Respiratory physiotherapy, end expiratory pressure, EzPAP®, cardiac surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Atelectasis</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/NCT02262182
org study id: RC14_0033
nct id: NCT02262182
lead sponsor: 
has dmc: No
Pulmonary atelectasis is a frequent respiratory postoperative complication in cardiac
      surgery. Classically, the treatment of these patients is based on manual chest physiotherapy.
      Our objective is to evaluate the interest of association of positive end expiratory delivery
      sessions with the EzPAP® device. We perform a prospective monocentric, open label trial.
      Patients with atelectasis after scheduled cardiac surgery with cardiopulmonary bypass are
      included. They benefit from manual chest therapy and are randomised to receive or not
      positive end expiratory pressure sessions twice a day. The primary endpoint is the effect of
      this treatment on atelectasis radiological score after 2 days of treatment. The secondary
      endpoints are: oxygen saturation(SpO2)/inspired oxygen(FiO2) ratio, qualitative evaluation of
      ventilatory function, respiratory & cardiac rate, pain, inspiratory pressure (sniff test),
      patient satisfaction, duration of intensive care unit (ICU) and hospital stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Radiological atelectasis score
time frame: Day 2 post-inclusion
description: This score was first described by Pasquina P et al in 2004
measure: Radiological atelectasis score
time frame: Days 1 and 3 post-inclusion
description: This score was first described by Pasquina P et al in 2004
measure: SpO2/FiO2 ratio
time frame: Days 1, 2 and 3 post inclusion
description: This ratio is measured before and after session
measure: Cardiac and respiratory rate
time frame: Days 1, 2 and 3 post inclusion
description: Measurement performed at the same time as SPO2 (patients are monitored)
measure: Qualitative evaluation of ventilatory function (nasal flaring, superficial tachypnea, use of accessory muscle, paradoxical abdominal respiration, cough difficulty) before and after session
time frame: Days 1, 2 and 3 post inclusion
description: This respiratory function assessment is performed in a qualitative way
measure: Dyspnea evaluation
time frame: Days 1, 2 and 3 post inclusion
description: Dyspnea is measured with a visual analogue scale before and after session
measure: Pain evaluation
time frame: Days 1, 2 and 3 post inclusion
description: Pain is measured with a visual analogue scale before and after session
measure: Vesicular murmur intensity
time frame: Days 1, 2 and 3 post inclusion
description: Vesicular murmur absent = 0, reduce = 1, present and normal = 2 Intensity is measured with an electronic stethoscope before and after session
measure: Inspiratory pressure measurement
time frame: Days 2 and 3 post inclusion
description: This measurement (so called sniff test) is assessed with MicroRPM device before and after session
measure: Assessment of patient satisfaction and tolerance of EzPAP device
time frame: Day 3 post inclusion
description: A questionnaire of 10 answer with semi-quantitative scale
arm group label: KP group
arm group type: Experimental
description: PEP delivery by EzPAP® device with manual chest physiotherapy .
arm group label: KM group
arm group type: Placebo Comparator
description: Manual chest physiotherapy only;
intervention type: Other
intervention name: KP group
arm group label: KP group
other name: Associated to manual chest physiotherapy, patients receive twice a day 4 periods of PEP delivery by EzPAP® device during 25 respiratory cycles.
intervention type: Other
intervention name: KM group
arm group label: KM group
other name: Patients of the control group benefit only from manual chest physiotherapy twice a day
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Pulmonary Atelectasis