<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/NCT02208479</url>
  </required_header>
  <id_info>
    <org_study_id>2014-13</org_study_id>
    <nct_id>NCT02208479</nct_id>
  </id_info>
  <brief_title>Cardiac Surgery and Diaphragm Function</brief_title>
  <official_title>Diaphragmatic Dysfunction in Cardiac Surgery: Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical&#xD;
      ventilation and cause respiratory distress.&#xD;
&#xD;
      The investigators' main objective is to determine the incidence of diaphragm dysfunction (&#xD;
      using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic&#xD;
      thickening fraction) in a selected population of cardiac surgery patients during weaning from&#xD;
      mechanical ventilation.&#xD;
&#xD;
      The second endpoints are to determine the associated risk factors to post-operative diaphragm&#xD;
      weakness and the consequence on the patient outcome.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Diaphragm inspiratory thickening fraction</measure>
    <time_frame>At the begining of the spontaneous breathing trial (around 4hours after surgery)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diaphragm dysfunction before surgery</measure>
    <time_frame>the day before surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity score (Euroscore)</measure>
    <time_frame>the day before surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>extracorporeal circulation duration</measure>
    <time_frame>peroperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>left ventricular ejection fraction</measure>
    <time_frame>the day before surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">66</enrollment>
  <condition>Cardiac Surgery</condition>
  <arm_group>
    <arm_group_label>cardiac surgery</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non invasive ultrasound measurement of the diaphragm thickness during breathing</intervention_name>
    <arm_group_label>cardiac surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patient admitted in Intensive Care Unit (ICU) after planned cardiac surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old and older&#xD;
&#xD;
          -  planned surgery&#xD;
&#xD;
          -  ready for weaning from mechanical ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  protected patient&#xD;
&#xD;
          -  patient 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>Unité de Réanimation Cardio-vasculaire et Thoracique</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.</citation>
    <PMID>24365607</PMID>
  </reference>
  <reference>
    <citation>McCool FD, Tzelepis GE. Dysfunction of the diaphragm. N Engl J Med. 2012 Mar 8;366(10):932-42. doi: 10.1056/NEJMra1007236. No abstract available. Erratum In: N Engl J Med. 2012 May 31;366(22):2138.</citation>
    <PMID>22397655</PMID>
  </reference>
  <reference>
    <citation>Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.</citation>
    <PMID>20813887</PMID>
  </reference>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>September 22, 2015</last_update_submitted>
  <last_update_submitted_qc>September 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 23, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cardiac surgery</keyword>
  <keyword>diaphragm dysfunction</keyword>
  <keyword>mechanical ventilation weaning</keyword>
  <keyword>respiratory paralysis</keyword>
  <keyword>muscle weakness</keyword>
  <keyword>cardiac bypass</keyword>
  <keyword>valvular surgery</keyword>
  <keyword>respiratory insufficiency</keyword>
  <!-- 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/NCT02208479
org study id: 2014-13
nct id: NCT02208479
lead sponsor: 
has dmc: No
Diaphragm dysfunction is common after cardiac surgery and may delay weaning from mechanical
      ventilation and cause respiratory distress.

      The investigators' main objective is to determine the incidence of diaphragm dysfunction (
      using the non-invasive ultrasonic method by calculating the inspiratory diaphragmatic
      thickening fraction) in a selected population of cardiac surgery patients during weaning from
      mechanical ventilation.

      The second endpoints are to determine the associated risk factors to post-operative diaphragm
      weakness and the consequence on the patient outcome.
observational model: Cohort
time perspective: Prospective
measure: Diaphragm inspiratory thickening fraction
time frame: At the begining of the spontaneous breathing trial (around 4hours after surgery)
measure: Diaphragm dysfunction before surgery
time frame: the day before surgery
measure: Severity score (Euroscore)
time frame: the day before surgery
measure: extracorporeal circulation duration
time frame: peroperative
measure: left ventricular ejection fraction
time frame: the day before surgery
arm group label: cardiac surgery
intervention type: Other
intervention name: Non invasive ultrasound measurement of the diaphragm thickness during breathing
arm group label: cardiac surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
citation: DiNino E, Gartman EJ, Sethi JM, McCool FD. Diaphragm ultrasound as a predictor of successful extubation from mechanical ventilation. Thorax. 2014 May;69(5):423-7. doi: 10.1136/thoraxjnl-2013-204111. Epub 2013 Dec 23.
PMID: 24365607
citation: McCool FD, Tzelepis GE. Dysfunction of the diaphragm. N Engl J Med. 2012 Mar 8;366(10):932-42. doi: 10.1056/NEJMra1007236. No abstract available. Erratum In: N Engl J Med. 2012 May 31;366(22):2138.
PMID: 22397655
citation: Jaber S, Petrof BJ, Jung B, Chanques G, Berthet JP, Rabuel C, Bouyabrine H, Courouble P, Koechlin-Ramonatxo C, Sebbane M, Similowski T, Scheuermann V, Mebazaa A, Capdevila X, Mornet D, Mercier J, Lacampagne A, Philips A, Matecki S. Rapidly progressive diaphragmatic weakness and injury during mechanical ventilation in humans. Am J Respir Crit Care Med. 2011 Feb 1;183(3):364-71. doi: 10.1164/rccm.201004-0670OC. Epub 2010 Sep 2.
PMID: 20813887
responsible party type: Sponsor