xml: <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/NCT06027008</url>
    </required_header>
    <id_info>
      <org_study_id>ACACIA</org_study_id>
      <nct_id>NCT06027008</nct_id>
    </id_info>
    <brief_title>Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults</brief_title>
    <acronym>ACACIA</acronym>
    <official_title>Mechanical Insufflation-Exsufflation (Cough Assist) in Critically Ill Adults (ACACIA)-a Randomized Clinical Feasibility Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this randomized feasibility trial is to evaluate the feasibility of Mechanical&#xD;
        Insufflation-Exsufflation (MI-E) in invasively ventilated critically ill patients.&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Is MI-E feasible?&#xD;
  &#xD;
          -  Is MI-E safe?&#xD;
  &#xD;
        Participants in the intervention group will receive:&#xD;
  &#xD;
          -  MI-E&#xD;
  &#xD;
          -  Airway secretions will be removed by endotracheal suctioning, as part of routine airway&#xD;
             care.&#xD;
  &#xD;
          -  Manual hyperinflation will only be used when necessary in an emergency situation.&#xD;
             Patients in the control group will receive endotracheal suctioning and manual&#xD;
             hyperinflation when clinically indicated.&#xD;
  &#xD;
        The primary outcome is the proportion of delivered MI-E sessions (2 times per calendar day a&#xD;
        MI-E session of 3 x 3 cycles of an in- and exsufflation) per patient according to study&#xD;
        protocol (feasibility). Secondary outcomes are the total number of serious adverse events in&#xD;
        relation to MI-E (safety) and preliminary exploratory data on the need for airway care&#xD;
        interventions and clinical outcomes including duration of invasive ventilation, length of&#xD;
        stay in ICU and mortality (efficacy).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Bedside nurses, trained in using the MI-E device, will apply MI-E sessions at two moments per&#xD;
        calendar day (morning and afternoon) for a maximum of 7 days while a patient is invasively&#xD;
        ventilated.&#xD;
  &#xD;
        MI-E settings are a 2-second insufflation and an immediate 2-second exsufflation. The cycles&#xD;
        of the MI-E session will be performed with a positive and negative pressure of 40 cmH2O. The&#xD;
        program is set up with the possibility of auto-triggering by the patient.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">May 2025</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>
      <intervention_model_description>Randomized feasibility trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Due to the nature of the intervention, blinding of healthcare professionals and any research personnel involved in the delivery of the intervention is not possible.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>intervention delivery</measure>
      <time_frame>max. 7 days</time_frame>
      <description>the proportion of complete sessions of MI-E every calender day (i.e. two MI-E sessions with 3 x 3 cycles of an in- and exsufflation) for all patients with a maximum of seven days of invasive ventilation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>incidence of pneumothorax (safety)</measure>
      <time_frame>max 7 days</time_frame>
      <description>incidence of pneumothorax for which drainage is needed attributed to MI-E or to routine airway care procedures (i.e., manual hyperinflation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>incidence of endotracheal tube obstruction (safety)</measure>
      <time_frame>max 7 days</time_frame>
      <description>incidence of endotracheal tube obstruction due to mucus plugging attributed to MI-E or regular airway care</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>incidence of severe hypoxemia (safety)</measure>
      <time_frame>max 7 days</time_frame>
      <description>incidence of severe hypoxemia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>incidence of severe hypotension (safety)</measure>
      <time_frame>max 7 days</time_frame>
      <description>incidence of severe hypotension</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>incidence of severe hypertension (safety)</measure>
      <time_frame>max 7 days</time_frame>
      <description>incidence of severe hypertension</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability of Intervention Measure (AIM)</measure>
      <time_frame>through study completion, estimated one year</time_frame>
      <description>1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intervention Appropriateness Measure (IAM)</measure>
      <time_frame>through study completion, estimated one year</time_frame>
      <description>1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility of Intervention Measure (FIM)</measure>
      <time_frame>through study completion, estimated one year</time_frame>
      <description>1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>amount of time needed for MI-E (feasibility)</measure>
      <time_frame>maximum of 1 hour per session</time_frame>
      <description>time needed to deliver the MI-E intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>endotracheal suctioning (feasibility)</measure>
      <time_frame>max. 7 days</time_frame>
      <description>frequency of endotracheal suctioning per ventilation day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MH (feasibility of MI-E)</measure>
      <time_frame>max. 7 days</time_frame>
      <description>frequency of manual hyperinflation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VAP (efficacy MI-E sample size calculation)</measure>
      <time_frame>28 days after inclusion</time_frame>
      <description>incidence of ventilator associated pneumonia (VAP)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>duration MV (efficacy MI-E sample size calculation)</measure>
      <time_frame>28 days after inclusion</time_frame>
      <description>duration of invasive ventilation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality day 28 (efficacy MI-E sample size calculation)</measure>
      <time_frame>up to day 28 from ICU admission</time_frame>
      <description>mortality at day 28</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VFD-28 (efficacy MI-E sample size calculation)</measure>
      <time_frame>28 days after inclusion</time_frame>
      <description>ventilator-free days at day 28</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU mortality (efficacy MI-E sample size calculation)</measure>
      <time_frame>28 days after inclusion</time_frame>
      <description>ICU mortality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hospital mortality (efficacy MI-E sample size calculation)</measure>
      <time_frame>28 days after inclusion</time_frame>
      <description>hospital mortality</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>supplemental oxygen (efficacy MI-E sample size calculation)</measure>
      <time_frame>28 days after inclusion</time_frame>
      <description>use of supplemental oxygen on ICU delivery after detubation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LOS ICU (efficacy MI-E sample size calculation)</measure>
      <time_frame>28 days after inclusion</time_frame>
      <description>length of stay in ICU</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LOS hospital (efficacy MI-E sample size calculation)</measure>
      <time_frame>28 days after inclusion</time_frame>
      <description>length of stay in hospital</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Critically Ill</condition>
    <arm_group>
      <arm_group_label>Mechanical Insufflation-Exsufflation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Invasively ventilated patients will receive MI-E until successful extubation or for a maximum of 7 days. MI-E will be given in the morning and afternoon each calendar day. Patients will be pre-oxygenated with FiO2 100% prior to disconnection from the ventilator; additional 15 litres oxygen can be added; A pre-set program is used: three times three cycles with a 2-second insufflation and an immediate 2-second exsufflation. The cycles of the MI-E session will be performed with a positive and negative pressure of 40 cmH2O. The program is set up with the possibility of auto-triggering by the patient.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard airway care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients in the control group will receive usual airway care which includes endotracheal suctioning and manual hyperinflation used when indicated based on clinical signs as part of regular airway care. Care protocols for endotracheal suctioning and manual hyperinflation are predefined. As with the intervention arm, there will be no use of saline instillation during suctioning. Manual hyperinflation technique is described in the care protocol of the intensive care unit and ICU nurses are trained to perform this technique.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Mechanical Insufflation-Exsufflation</intervention_name>
      <description>MI-E will be applied twice a day in invasively ventilated patients. Since the severity of illness can change in the ICU, each day the attending nurse will check for clinical reasons to not apply MI-E with regard to safety. The following clinical criteria are predefined as a reason to refrain from MI-E at that day:&#xD;
  severe ventilator instability (requiring &gt; 12 cm H2O PEEP and dependency of &gt; 60% FiO2);&#xD;
  severe hemodynamic instability (a need for large and sustained increase in continuous administration of intravenous vasopressive medication that are adjusted on a frequent basis in each nursing shift);&#xD;
  extra corporal membrane oxygenation (ECMO); and&#xD;
  deeply sedated patient (RASS score ≤ -4).</description>
      <arm_group_label>Mechanical Insufflation-Exsufflation</arm_group_label>
      <other_name>Cough assist</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  admission to one of the participating ICUs;&#xD;
  &#xD;
            -  receiving invasive mechanical ventilation via an endotracheal tube; and&#xD;
  &#xD;
            -  expected to need invasive ventilation for more than 48 hours from consideration for&#xD;
               inclusion.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  use of MI-E before hospital admission, i.e., at home;&#xD;
  &#xD;
            -  known presence of bullous emphysema;&#xD;
  &#xD;
            -  known bronchopleural fistula;&#xD;
  &#xD;
            -  known pneumothorax or pneumomediastinum;&#xD;
  &#xD;
            -  known rib fractures;&#xD;
  &#xD;
            -  known barotrauma;&#xD;
  &#xD;
            -  known unstable spinal fractures;&#xD;
  &#xD;
            -  unsecured subarachnoidal haemorrhage;&#xD;
  &#xD;
            -  uncontrollable intracranial pressures; and&#xD;
  &#xD;
            -  any infection, or colonization with pathogens that requires strict aerogenic&#xD;
               isolation. With an exception for patients in cohort isolation due to COVID-19.&#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>Frederique Paulus, RN, PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Amsterdam UMC - intensive care</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Frederique Paulus, RN, PHD</last_name>
      <phone>+31-20-5669111</phone>
      <email>f.paulus@amsterdamumc.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Willemke Stilma, RN, MSc, LLM</last_name>
      <phone>+31-20-5669111</phone>
      <email>w.stilma@amsterdamumc.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</name>
        <address>
          <city>Amsterdam</city>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Willemke Stilma, RN, MSc, LLM</last_name>
        <phone>+31-20-5669111</phone>
        <email>w.stilma@amsterdamumc.nl</email>
      </contact>
      <contact_backup>
        <last_name>Frederique Paulus, PHD</last_name>
        <phone>+31-20-5669111</phone>
        <email>f.paulus@amsterdamumc.nl</email>
      </contact_backup>
      <investigator>
        <last_name>Marcus J Schultz, MD, PHD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Frederique Paulus, RN, PHD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <reference>
      <citation>Stilma W, Verweij L, Spek B, Scholte Op Reimer WJM, Schultz MJ, Paulus F, Rose L. Mechanical insufflation-exsufflation for invasively ventilated critically ill patients-A focus group study. Nurs Crit Care. 2022 Dec 4. doi: 10.1111/nicc.12858. Online ahead of print.</citation>
      <PMID>36464804</PMID>
    </reference>
    <reference>
      <citation>Swingwood EL, Stilma W, Tume LN, Cramp F, Voss S, Bewley J, Ntoumenopoulos G, Schultz MJ, Scholte Op Reimer W, Paulus F, Rose L. The Use of Mechanical Insufflation-Exsufflation in Invasively Ventilated Critically Ill Adults. Respir Care. 2022 Aug;67(8):1043-1057. doi: 10.4187/respcare.09704. Epub 2022 May 24.</citation>
      <PMID>35610033</PMID>
    </reference>
    <reference>
      <citation>Rose L, Adhikari NK, Leasa D, Fergusson DA, McKim D. Cough augmentation techniques for extubation or weaning critically ill patients from mechanical ventilation. Cochrane Database Syst Rev. 2017 Jan 11;1(1):CD011833. doi: 10.1002/14651858.CD011833.pub2.</citation>
      <PMID>28075489</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>February 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
      <investigator_full_name>Prof. Dr. Marcus J. Schultz</investigator_full_name>
      <investigator_title>Prof. dr.</investigator_title>
    </responsible_party>
    <keyword>Mechanical insufflation-exsufflation</keyword>
    <keyword>Cough Assist</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Currently, there is no decision on a data sharing plan</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027008
  org study id: ACACIA
  nct id: NCT06027008
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized feasibility trial is to evaluate the feasibility of Mechanical
        Insufflation-Exsufflation (MI-E) in invasively ventilated critically ill patients.
  
        The main question[s] it aims to answer are:
  
          -  Is MI-E feasible?
  
          -  Is MI-E safe?
  
        Participants in the intervention group will receive:
  
          -  MI-E
  
          -  Airway secretions will be removed by endotracheal suctioning, as part of routine airway
             care.
  
          -  Manual hyperinflation will only be used when necessary in an emergency situation.
             Patients in the control group will receive endotracheal suctioning and manual
             hyperinflation when clinically indicated.
  
        The primary outcome is the proportion of delivered MI-E sessions (2 times per calendar day a
        MI-E session of 3 x 3 cycles of an in- and exsufflation) per patient according to study
        protocol (feasibility). Secondary outcomes are the total number of serious adverse events in
        relation to MI-E (safety) and preliminary exploratory data on the need for airway care
        interventions and clinical outcomes including duration of invasive ventilation, length of
        stay in ICU and mortality (efficacy).
  Bedside nurses, trained in using the MI-E device, will apply MI-E sessions at two moments per
        calendar day (morning and afternoon) for a maximum of 7 days while a patient is invasively
        ventilated.
  
        MI-E settings are a 2-second insufflation and an immediate 2-second exsufflation. The cycles
        of the MI-E session will be performed with a positive and negative pressure of 40 cmH2O. The
        program is set up with the possibility of auto-triggering by the patient.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized feasibility trial
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: Due to the nature of the intervention, blinding of healthcare professionals and any research personnel involved in the delivery of the intervention is not possible.
  measure: intervention delivery
  time frame: max. 7 days
  description: the proportion of complete sessions of MI-E every calender day (i.e. two MI-E sessions with 3 x 3 cycles of an in- and exsufflation) for all patients with a maximum of seven days of invasive ventilation
  measure: incidence of pneumothorax (safety)
  time frame: max 7 days
  description: incidence of pneumothorax for which drainage is needed attributed to MI-E or to routine airway care procedures (i.e., manual hyperinflation)
  measure: incidence of endotracheal tube obstruction (safety)
  time frame: max 7 days
  description: incidence of endotracheal tube obstruction due to mucus plugging attributed to MI-E or regular airway care
  measure: incidence of severe hypoxemia (safety)
  time frame: max 7 days
  description: incidence of severe hypoxemia
  measure: incidence of severe hypotension (safety)
  time frame: max 7 days
  description: incidence of severe hypotension
  measure: incidence of severe hypertension (safety)
  time frame: max 7 days
  description: incidence of severe hypertension
  measure: Acceptability of Intervention Measure (AIM)
  time frame: through study completion, estimated one year
  description: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)
  measure: Intervention Appropriateness Measure (IAM)
  time frame: through study completion, estimated one year
  description: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)
  measure: Feasibility of Intervention Measure (FIM)
  time frame: through study completion, estimated one year
  description: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Response scale 1 (completely disagree) - 5 (completely agree)
  measure: amount of time needed for MI-E (feasibility)
  time frame: maximum of 1 hour per session
  description: time needed to deliver the MI-E intervention
  measure: endotracheal suctioning (feasibility)
  time frame: max. 7 days
  description: frequency of endotracheal suctioning per ventilation day
  measure: MH (feasibility of MI-E)
  time frame: max. 7 days
  description: frequency of manual hyperinflation
  measure: VAP (efficacy MI-E sample size calculation)
  time frame: 28 days after inclusion
  description: incidence of ventilator associated pneumonia (VAP)
  measure: duration MV (efficacy MI-E sample size calculation)
  time frame: 28 days after inclusion
  description: duration of invasive ventilation
  measure: Mortality day 28 (efficacy MI-E sample size calculation)
  time frame: up to day 28 from ICU admission
  description: mortality at day 28
  measure: VFD-28 (efficacy MI-E sample size calculation)
  time frame: 28 days after inclusion
  description: ventilator-free days at day 28
  measure: ICU mortality (efficacy MI-E sample size calculation)
  time frame: 28 days after inclusion
  description: ICU mortality
  measure: hospital mortality (efficacy MI-E sample size calculation)
  time frame: 28 days after inclusion
  description: hospital mortality
  measure: supplemental oxygen (efficacy MI-E sample size calculation)
  time frame: 28 days after inclusion
  description: use of supplemental oxygen on ICU delivery after detubation
  measure: LOS ICU (efficacy MI-E sample size calculation)
  time frame: 28 days after inclusion
  description: length of stay in ICU
  measure: LOS hospital (efficacy MI-E sample size calculation)
  time frame: 28 days after inclusion
  description: length of stay in hospital
  arm group label: Mechanical Insufflation-Exsufflation
  arm group type: Experimental
  description: Invasively ventilated patients will receive MI-E until successful extubation or for a maximum of 7 days. MI-E will be given in the morning and afternoon each calendar day. Patients will be pre-oxygenated with FiO2 100% prior to disconnection from the ventilator; additional 15 litres oxygen can be added; A pre-set program is used: three times three cycles with a 2-second insufflation and an immediate 2-second exsufflation. The cycles of the MI-E session will be performed with a positive and negative pressure of 40 cmH2O. The program is set up with the possibility of auto-triggering by the patient.
  arm group label: Standard airway care
  arm group type: No Intervention
  description: Patients in the control group will receive usual airway care which includes endotracheal suctioning and manual hyperinflation used when indicated based on clinical signs as part of regular airway care. Care protocols for endotracheal suctioning and manual hyperinflation are predefined. As with the intervention arm, there will be no use of saline instillation during suctioning. Manual hyperinflation technique is described in the care protocol of the intensive care unit and ICU nurses are trained to perform this technique.
  intervention type: Device
  intervention name: Mechanical Insufflation-Exsufflation
  description: MI-E will be applied twice a day in invasively ventilated patients. Since the severity of illness can change in the ICU, each day the attending nurse will check for clinical reasons to not apply MI-E with regard to safety. The following clinical criteria are predefined as a reason to refrain from MI-E at that day:
  severe ventilator instability (requiring > 12 cm H2O PEEP and dependency of > 60% FiO2);
  severe hemodynamic instability (a need for large and sustained increase in continuous administration of intravenous vasopressive medication that are adjusted on a frequent basis in each nursing shift);
  extra corporal membrane oxygenation (ECMO); and
  deeply sedated patient (RASS score ≤ -4).
  arm group label: Mechanical Insufflation-Exsufflation
  other name: Cough assist
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Frederique Paulus, RN, PHD
  role: Principal Investigator
  affiliation: Amsterdam UMC - intensive care
  last name: Frederique Paulus, RN, PHD
  phone: +31-20-5669111
  email: f.paulus@amsterdamumc.nl
  last name: Willemke Stilma, RN, MSc, LLM
  phone: +31-20-5669111
  email: w.stilma@amsterdamumc.nl
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Netherlands
  citation: Stilma W, Verweij L, Spek B, Scholte Op Reimer WJM, Schultz MJ, Paulus F, Rose L. Mechanical insufflation-exsufflation for invasively ventilated critically ill patients-A focus group study. Nurs Crit Care. 2022 Dec 4. doi: 10.1111/nicc.12858. Online ahead of print.
  PMID: 36464804
  citation: Swingwood EL, Stilma W, Tume LN, Cramp F, Voss S, Bewley J, Ntoumenopoulos G, Schultz MJ, Scholte Op Reimer W, Paulus F, Rose L. The Use of Mechanical Insufflation-Exsufflation in Invasively Ventilated Critically Ill Adults. Respir Care. 2022 Aug;67(8):1043-1057. doi: 10.4187/respcare.09704. Epub 2022 May 24.
  PMID: 35610033
  citation: Rose L, Adhikari NK, Leasa D, Fergusson DA, McKim D. Cough augmentation techniques for extubation or weaning critically ill patients from mechanical ventilation. Cochrane Database Syst Rev. 2017 Jan 11;1(1):CD011833. doi: 10.1002/14651858.CD011833.pub2.
  PMID: 28075489
  responsible party type: Principal Investigator
  investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  investigator full name: Prof. Dr. Marcus J. Schultz
  investigator title: Prof. dr.
  mesh term: Critical Illness
  sharing ipd: No
  ipd description: Currently, there is no decision on a data sharing plan