<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/NCT04475185</url>
  </required_header>
  <id_info>
    <org_study_id>RC20_0173</org_study_id>
    <nct_id>NCT04475185</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness Assessment of the MakAir Artificial Ventilator</brief_title>
  <acronym>COVRESP</acronym>
  <official_title>Interventional, Open, Non-comparative, Multicenter Study to Assess the Safety and Effectiveness of the Use of the MakAir Artificial Ventilator in the Expected Situation of a Shortage of Technical Devices for Invasive Mechanical Ventilation, Linked to the Coronavirus COVID-19</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of our study is to carry out an evaluation of the safety and the effectiveness&#xD;
      of the use of the MakAir respirator as useful supplement in situation of shortage of&#xD;
      technical devices of assistance to the mechanical invasive ventilation, related to COVID-19&#xD;
      through a protocol in 3 successive sequences.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Manufacturer's decision following failure of sequence 2. Protocol unadapted to the security and&#xD;
    performance evaluation of the new MakAir device capabilities in non-invasive ventilation (NIV).&#xD;
  </why_stopped>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">December 19, 2020</completion_date>
  <primary_completion_date type="Actual">December 19, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of dysfunctions</measure>
    <time_frame>24 hours for sequence 1</time_frame>
    <description>Number of dysfunctions which can lead to or have led to &quot;respiratory&quot; adverse events or to serious adverse events (SAE)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of dysfunctions</measure>
    <time_frame>5 days for sequence 2</time_frame>
    <description>Number of dysfunctions which can lead to or have led to &quot;respiratory&quot; adverse events or to serious adverse events (SAE)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of dysfunctions</measure>
    <time_frame>10 days for sequence 3</time_frame>
    <description>Number of dysfunctions which can lead to or have led to &quot;respiratory&quot; adverse events or to serious adverse events (SAE)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>MakAir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MakAir</intervention_name>
    <description>MakAir artificial ventilator</description>
    <arm_group_label>MakAir</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Sequence 1 :&#xD;
&#xD;
          -  Patient for whom a certificate has been signed by a support person / family member /&#xD;
             close relative independent of the sponsor.&#xD;
&#xD;
          -  Adult&#xD;
&#xD;
          -  Non-hypoxemic patient (PaO2 / FiO2&gt; 300)&#xD;
&#xD;
          -  Patient requiring invasive mechanical ventilation&gt; 24 hours&#xD;
&#xD;
          -  Stabilized patient, i.e. not needing an increase in oxygenation for at least 6 hours&#xD;
&#xD;
        Sequence 2 :&#xD;
&#xD;
          -  Patient for whom a certificate of consent has been signed by a support person / family&#xD;
             member / close relative independent of the sponsor.&#xD;
&#xD;
          -  Adult&#xD;
&#xD;
          -  Patient with mild to moderate Acute respiratory distress syndrome (300&gt; Pa02 / FiO2&gt;&#xD;
             100)&#xD;
&#xD;
          -  Patient requiring invasive mechanical ventilation&gt; 3 days&#xD;
&#xD;
          -  Stabilized patient, i.e. having not required an increase in oxygenation for at least 6&#xD;
             hours&#xD;
&#xD;
        Sequence3 :&#xD;
&#xD;
          -  Patient for whom a certificate of consent has been signed by a support person / family&#xD;
             member / close relative independent of the sponsor or waiver due to life-threatening&#xD;
             emergency.&#xD;
&#xD;
          -  Adult&#xD;
&#xD;
          -  Patient with mild to moderate Acute respiratory distress syndrome (PaO2 / FiO2&gt; 100)&#xD;
             or without Acute respiratory distress syndrome&#xD;
&#xD;
          -  Patient requiring invasive mechanical ventilation for any duration&#xD;
&#xD;
          -  Situation of shortage among centers investigating technical devices for invasive&#xD;
             ventilation to treat all patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Sequence 1 and sequence 2:&#xD;
&#xD;
          -  Patient positive or showing signs of Covid-19 infection&#xD;
&#xD;
          -  Tracheotomized patient&#xD;
&#xD;
          -  History of pulmonary emphysema or severe to moderate chronic obstructive pulmonary&#xD;
             disease&#xD;
&#xD;
          -  Patient in recovery and withdrawal phase of ventilatory assistance&#xD;
&#xD;
          -  Pneumothorax or pneumomediastinum&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  Intracranial hypertension&#xD;
&#xD;
          -  Pregnant woman (A urine or blood pregnancy test must be performed for women of&#xD;
             childbearing age)&#xD;
&#xD;
          -  Major protected (guardianship, curatorship and under the protection of justice)&#xD;
&#xD;
          -  Lack of affiliation to the French social security system&#xD;
&#xD;
          -  Participation in another interventional clinical trial&#xD;
&#xD;
        Sequence3 :&#xD;
&#xD;
          -  Tracheotomized patient&#xD;
&#xD;
          -  History of pulmonary emphysema or severe to moderate moderate chronic obstructive&#xD;
             pulmonary disease&#xD;
&#xD;
          -  Patient in recovery and withdrawal phase of ventilatory assistance&#xD;
&#xD;
          -  Pneumothorax or pneumomediastinum&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  Intracranial hypertension&#xD;
&#xD;
          -  Pregnant woman (A urine or blood pregnancy test must be performed for women of&#xD;
             childbearing age)&#xD;
&#xD;
          -  Major protected (guardianship, curatorship and under the protection of justice)&#xD;
&#xD;
          -  Lack of affiliation to the French social security system&#xD;
&#xD;
          -  Participation in another interventional clinical trial on mechanical ventilation&#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>Antoine Roquilly, MD</last_name>
    <role>Study Director</role>
    <affiliation>CHU Nantes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU Brest</name>
      <address>
        <city>Brest</city>
        <state>Finistère</state>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <state>Loire-Atlantique</state>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>December 8, 2021</last_update_submitted>
  <last_update_submitted_qc>December 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</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/NCT04475185
org study id: RC20_0173
nct id: NCT04475185
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of our study is to carry out an evaluation of the safety and the effectiveness
      of the use of the MakAir respirator as useful supplement in situation of shortage of
      technical devices of assistance to the mechanical invasive ventilation, related to COVID-19
      through a protocol in 3 successive sequences.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of dysfunctions
time frame: 24 hours for sequence 1
description: Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)
measure: Number of dysfunctions
time frame: 5 days for sequence 2
description: Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)
measure: Number of dysfunctions
time frame: 10 days for sequence 3
description: Number of dysfunctions which can lead to or have led to "respiratory" adverse events or to serious adverse events (SAE)
arm group label: MakAir
arm group type: Experimental
intervention type: Device
intervention name: MakAir
description: MakAir artificial ventilator
arm group label: MakAir
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Antoine Roquilly, MD
role: Study Director
affiliation: CHU Nantes
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury