<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/NCT02236104</url>
  </required_header>
  <id_info>
    <org_study_id>2010-A01042-37</org_study_id>
    <nct_id>NCT02236104</nct_id>
  </id_info>
  <brief_title>Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.</brief_title>
  <acronym>coughassistAFM</acronym>
  <official_title>Effect of Mechanical Insufflation-exsufflation on Respiratory Parameters in Two Neuromuscular Populations.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre d'Investigation Clinique et Technologique 805</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Versailles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre d'Investigation Clinique et Technologique 805</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve&#xD;
      airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to&#xD;
      confirm the beneficial effects of this treatment in a larger neuromuscular population, to&#xD;
      study its mechanisms of action and to assess whether the effects observed persist over time.&#xD;
      A better knowledge of this treatment should help to define its position in the respiratory&#xD;
      management of neuromuscular patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      30 SMA and DMD adult patients will be recruited in the home ventilation unit of the intensive&#xD;
      care department of Raymond Poincaré Hospital (Assistance Publique-Hôpitaux de Paris,Garches,&#xD;
      France).&#xD;
&#xD;
      Respiratory parameters and comfort will be evaluated before and after (5min,&#xD;
&#xD;
      1h, 3h) a MI-E session. Vital capacity, maximal inspiratory and expiratory pressures (PImax&#xD;
      and PEmax), peak cough flow and peak expiratory flows will be measured. Breathing pattern&#xD;
      will be recorded allowing the measurements of respiratory frequency, tidal volume,&#xD;
      Inspiratory time (Ti),total breath (Ttot) during tidal breathing and the calculation of&#xD;
      tension-time index (TT0.1).&#xD;
&#xD;
      Gas exchange will be evaluated by measuring end tidal CO2, transcutaneous CO2 and pulse&#xD;
      oxymetry.&#xD;
&#xD;
      Respiratory comfort will be assessed with a visual analog scale. Optoelectronic&#xD;
      plethysmography will be use to perform regional ventilation evaluation. Using chest wall&#xD;
      motion analysis we will compute respiratory participation of upper, lower thorax and abdomen,&#xD;
      right and left side.&#xD;
&#xD;
      Results should allow to analyse the effects of MI-E on regional ventilation. The mechanisms&#xD;
      of action of MI-E on respiration and chest-wall motion will be analysed and the persistence&#xD;
      of the beneficial effect of MI-E will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2010</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">May 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>maximal inspiratory pressures</measure>
    <time_frame>2 hours</time_frame>
    <description>measure of maximal inspiratory pressures before mechanical insufflation-exsufflation session, just after this session and an hour after.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Mechanical Insufflation-exsufflation Session ( With Cough Assist)</condition>
  <arm_group>
    <arm_group_label>cough assist session</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mechanical insufflation-exsufflation contains 15 cycles durea 2-3 seconds. pressure level fixed +/-30 cm H2O.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Plethysmography opto electronic</intervention_name>
    <arm_group_label>cough assist session</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>respiratory parameters</intervention_name>
    <arm_group_label>cough assist session</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged more than 18 years&#xD;
&#xD;
          -  Written consents&#xD;
&#xD;
          -  Neuromuscular disorders&#xD;
&#xD;
          -  Hemodynamic stability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pulmonary disorder&#xD;
&#xD;
          -  Acute respiratory failure&#xD;
&#xD;
          -  Cognitive deficit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frederic LOFASO, MD PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Raymond poincare hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michel Petitjean, MDPHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Raymond Poincare hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Raymond Poincaré</name>
      <address>
        <city>Garches</city>
        <zip>92380</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>March 23, 2015</last_update_submitted>
  <last_update_submitted_qc>March 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neuromuscular disorders</keyword>
  <keyword>mechanical insufflation-exsufflation</keyword>
  <keyword>respiratory parameters</keyword>
  <keyword>plethysmography opto electronic</keyword>
  <keyword>Vital capacity</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/NCT02236104
org study id: 2010-A01042-37
nct id: NCT02236104
lead sponsor: 
collaborator: 
has dmc: No
A single session of Mechanical Insufflation-Exsufflation (with Cough AssistÒ) may improve
      airway flow and gas exchange in neuromuscular atrophy patients. The goal of this study is to
      confirm the beneficial effects of this treatment in a larger neuromuscular population, to
      study its mechanisms of action and to assess whether the effects observed persist over time.
      A better knowledge of this treatment should help to define its position in the respiratory
      management of neuromuscular patients.
30 SMA and DMD adult patients will be recruited in the home ventilation unit of the intensive
      care department of Raymond Poincaré Hospital (Assistance Publique-Hôpitaux de Paris,Garches,
      France).

      Respiratory parameters and comfort will be evaluated before and after (5min,

      1h, 3h) a MI-E session. Vital capacity, maximal inspiratory and expiratory pressures (PImax
      and PEmax), peak cough flow and peak expiratory flows will be measured. Breathing pattern
      will be recorded allowing the measurements of respiratory frequency, tidal volume,
      Inspiratory time (Ti),total breath (Ttot) during tidal breathing and the calculation of
      tension-time index (TT0.1).

      Gas exchange will be evaluated by measuring end tidal CO2, transcutaneous CO2 and pulse
      oxymetry.

      Respiratory comfort will be assessed with a visual analog scale. Optoelectronic
      plethysmography will be use to perform regional ventilation evaluation. Using chest wall
      motion analysis we will compute respiratory participation of upper, lower thorax and abdomen,
      right and left side.

      Results should allow to analyse the effects of MI-E on regional ventilation. The mechanisms
      of action of MI-E on respiration and chest-wall motion will be analysed and the persistence
      of the beneficial effect of MI-E will be assessed.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: maximal inspiratory pressures
time frame: 2 hours
description: measure of maximal inspiratory pressures before mechanical insufflation-exsufflation session, just after this session and an hour after.
arm group label: cough assist session
arm group type: Experimental
description: Mechanical insufflation-exsufflation contains 15 cycles durea 2-3 seconds. pressure level fixed +/-30 cm H2O.
intervention type: Device
intervention name: Plethysmography opto electronic
arm group label: cough assist session
intervention type: Procedure
intervention name: respiratory parameters
arm group label: cough assist session
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Frederic LOFASO, MD PHD
role: Principal Investigator
affiliation: Raymond poincare hospital
last name: Michel Petitjean, MDPHD
role: Principal Investigator
affiliation: Raymond Poincare hospital
facility: 
country: France
responsible party type: Sponsor