<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/NCT03761823</url>
  </required_header>
  <id_info>
    <org_study_id>DYSPHAGIA ICU HH17</org_study_id>
    <nct_id>NCT03761823</nct_id>
  </id_info>
  <brief_title>Post-extubation Dysphagia</brief_title>
  <official_title>The Pathophysiology of Post-extubation Dysphagia in ICU Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</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>
      Mechanical ventilation is a widely used treatment on the Intensive Care Unit (ICU).&#xD;
      Swallowing dysfunction (dysphagia) after extubation may cause aspiration, and is associated&#xD;
      with poor outcomes: pneumonia, reintubation, a prolonged length of hospital stay and&#xD;
      increased mortality. The exact underlying pathophysiology of post-extubation dysphagia (PED)&#xD;
      is unknown. This exploratory pilot study is the first step that aims to fill this knowledge&#xD;
      gap to ultimately improve current treatment and prevention of post-extubation dysphagia.&#xD;
&#xD;
      Using FEES (Flexible Endoscopic Evaluation of Swallowing), HRIM (High Resolution Impedance&#xD;
      Manometry) and EMG (electromyography) simultaneously, 5 healthy subjects and 25 patients&#xD;
      within 24 hours after extubation will be studied.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational study model:&#xD;
&#xD;
      The group of healthy subjects will be recruited using posters at the local university and the&#xD;
      internet. The healthy subjects will be studied before the group of patients to assess the&#xD;
      feasibility and possible interactions of simultaneously recording FEES, HRIM and EMG. Then,&#xD;
      the group of patients will be studied. They will be recruited from the Intensive Care Unit.&#xD;
      See In- and Exclusion criteria for details.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Organizational issues and slow inclusion rate&#xD;
  </why_stopped>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</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>The number of patients with aspiration during FEES will be assessed.</measure>
    <time_frame>At time of measurement (within 24 hours post-extubation)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pathophysiology of PED</measure>
    <time_frame>At time of measurement (within 24 hours post-extubation)</time_frame>
    <description>The pathophysiology of PED will be determined after simultaneous measurement of FEES, HRIM and EMG. The pathophysiology will be classified into several categories: reduced pharyngeal contractility / muscular weakness, reduced upper esophageal sphincter (UES) opening/relaxation, direct oropharyngeal or laryngeal trauma of the tube, reduced laryngeal sensibility, among other categories. To enable classification, parameters obtained from FEES, HRIM and EMG will be used. FEES: presence of penetration and aspiration, residue, reduced sensibility (among others); HRIM: pharyngeal peak pressure, UES maximum admittance, intrabolus pressure (among others); EMG: duration of muscle activity (among others).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of adverse events will be assessed.</measure>
    <time_frame>Participants will be followed until hospital discharge, an expected average of 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interaction of FEES on HRIM recording</measure>
    <time_frame>At time of measurement (within 24 hours post-extubation)</time_frame>
    <description>HRIM outcomes during the simultaneous recording will be compared with outcomes of recording with only HRIM in situ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of FEES with HRIM</measure>
    <time_frame>At time of measurement (within 24 hours post-extubation)</time_frame>
    <description>The correlation of FEES outcomes, e.g. PAS and residue, with HRIM outcomes, e.g. swallow risk index and post-swallow impedance ratio.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The number of patients that develop pneumonia will be assessed.</measure>
    <time_frame>Participants will be followed until hospital discharge, an expected average of 28 days</time_frame>
    <description>Pneumonia is defined according to the Center of Disease Control criteria.</description>
  </other_outcome>
  <other_outcome>
    <measure>Reintubation rate (dysphagia vs. non-dysphagia)</measure>
    <time_frame>Participants will be followed until hospital discharge, an expected average of 28 days</time_frame>
    <description>The number of patients that are reintubated during their hospital stay will be assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>ICU readmission rate (dysphagia vs. non-dysphagia)</measure>
    <time_frame>Participants will be followed until hospital discharge, an expected average of 28 days</time_frame>
    <description>The number of patients that are readmitted to the ICU during their hospital stay will be assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of ICU stay (dysphagia vs. non-dysphagia)</measure>
    <time_frame>Participants will be followed until hospital discharge, an expected average of 28 days</time_frame>
    <description>Length of ICU stay will be assessed (in days).</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of hospital stay (dysphagia vs. non-dysphagia)</measure>
    <time_frame>Participants will be followed until hospital discharge, an expected average of 28 days</time_frame>
    <description>Length of hospital stay will be assessed (in days).</description>
  </other_outcome>
  <other_outcome>
    <measure>ICU mortality (dysphagia vs. non-dysphagia)</measure>
    <time_frame>Participants will be followed until hospital discharge, an expected average of 28 days</time_frame>
    <description>The incidence of mortality during ICU stay will be assessed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospital mortality (dysphagia vs. non-dysphagia)</measure>
    <time_frame>Participants will be followed until hospital discharge, an expected average of 28 days</time_frame>
    <description>The incidence of mortality during hospital stay will be assessed.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">5</enrollment>
  <condition>Post-extubation Dysphagia</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <description>Healthy subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients extubated after &gt; 5 days of mechanical ventilation.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy subjects will be recruited using posters at the local university and the internet.&#xD;
&#xD;
        Intensive care patients that will be extubated shortly.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (patients):&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  extubated after endotracheal intubation for more than 5 days&#xD;
&#xD;
          -  Richmond Agitation-Sedation Scale (RASS) between -2 and 2&#xD;
&#xD;
          -  able to sit right up&#xD;
&#xD;
          -  no respiratory insufficiency/failure (for this study defined as oxygen saturation&#xD;
             (SpO2) &lt; 92% with a minimum of 3 L nasal oxygen)&#xD;
&#xD;
        Inclusion Criteria (healthy subjects):&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria (both patients and healthy subjects):&#xD;
&#xD;
          -  pre-existing dysphagia (according to medical record and screening)&#xD;
&#xD;
          -  tracheostomy or previous tracheostomy&#xD;
&#xD;
          -  history of prior intubation &lt; 3 months ago&#xD;
&#xD;
          -  head/neck surgery, head/neck radiation or head/neck disease&#xD;
&#xD;
          -  pre-existent esophageal disorder&#xD;
&#xD;
          -  coagulopathy (thrombocytes &lt; 50*10^9 /l, or prothrombin time (PT)/activated partial&#xD;
             thromboplastin time (APTT) &gt; 1.5 times the reference value, or fibrinogen &lt; 1000 mg/l,&#xD;
             or use of therapeutic anticoagulant drugs)&#xD;
&#xD;
          -  allergy for xylometazoline (only in case its use is indicated)&#xD;
&#xD;
          -  known pregnancy&#xD;
&#xD;
          -  known G6PD deficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Johannes G. van der Hoeven, prof. dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboudumc</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>February 2, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>April 13, 2022</last_update_submitted>
  <last_update_submitted_qc>April 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Flexible endoscopic evaluation of swallowing</keyword>
  <keyword>High resolution impedance manometry</keyword>
  <keyword>Electromyography</keyword>
  <keyword>Intensive Care Unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</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/NCT03761823
org study id: DYSPHAGIA ICU HH17
nct id: NCT03761823
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Mechanical ventilation is a widely used treatment on the Intensive Care Unit (ICU).
      Swallowing dysfunction (dysphagia) after extubation may cause aspiration, and is associated
      with poor outcomes: pneumonia, reintubation, a prolonged length of hospital stay and
      increased mortality. The exact underlying pathophysiology of post-extubation dysphagia (PED)
      is unknown. This exploratory pilot study is the first step that aims to fill this knowledge
      gap to ultimately improve current treatment and prevention of post-extubation dysphagia.

      Using FEES (Flexible Endoscopic Evaluation of Swallowing), HRIM (High Resolution Impedance
      Manometry) and EMG (electromyography) simultaneously, 5 healthy subjects and 25 patients
      within 24 hours after extubation will be studied.
Observational study model:

      The group of healthy subjects will be recruited using posters at the local university and the
      internet. The healthy subjects will be studied before the group of patients to assess the
      feasibility and possible interactions of simultaneously recording FEES, HRIM and EMG. Then,
      the group of patients will be studied. They will be recruited from the Intensive Care Unit.
      See In- and Exclusion criteria for details.
observational model: Cohort
time perspective: Prospective
measure: The number of patients with aspiration during FEES will be assessed.
time frame: At time of measurement (within 24 hours post-extubation)
measure: Pathophysiology of PED
time frame: At time of measurement (within 24 hours post-extubation)
description: The pathophysiology of PED will be determined after simultaneous measurement of FEES, HRIM and EMG. The pathophysiology will be classified into several categories: reduced pharyngeal contractility / muscular weakness, reduced upper esophageal sphincter (UES) opening/relaxation, direct oropharyngeal or laryngeal trauma of the tube, reduced laryngeal sensibility, among other categories. To enable classification, parameters obtained from FEES, HRIM and EMG will be used. FEES: presence of penetration and aspiration, residue, reduced sensibility (among others); HRIM: pharyngeal peak pressure, UES maximum admittance, intrabolus pressure (among others); EMG: duration of muscle activity (among others).
measure: The number of adverse events will be assessed.
time frame: Participants will be followed until hospital discharge, an expected average of 28 days
measure: Interaction of FEES on HRIM recording
time frame: At time of measurement (within 24 hours post-extubation)
description: HRIM outcomes during the simultaneous recording will be compared with outcomes of recording with only HRIM in situ.
measure: Correlation of FEES with HRIM
time frame: At time of measurement (within 24 hours post-extubation)
description: The correlation of FEES outcomes, e.g. PAS and residue, with HRIM outcomes, e.g. swallow risk index and post-swallow impedance ratio.
measure: The number of patients that develop pneumonia will be assessed.
time frame: Participants will be followed until hospital discharge, an expected average of 28 days
description: Pneumonia is defined according to the Center of Disease Control criteria.
measure: Reintubation rate (dysphagia vs. non-dysphagia)
time frame: Participants will be followed until hospital discharge, an expected average of 28 days
description: The number of patients that are reintubated during their hospital stay will be assessed.
measure: ICU readmission rate (dysphagia vs. non-dysphagia)
time frame: Participants will be followed until hospital discharge, an expected average of 28 days
description: The number of patients that are readmitted to the ICU during their hospital stay will be assessed.
measure: Length of ICU stay (dysphagia vs. non-dysphagia)
time frame: Participants will be followed until hospital discharge, an expected average of 28 days
description: Length of ICU stay will be assessed (in days).
measure: Length of hospital stay (dysphagia vs. non-dysphagia)
time frame: Participants will be followed until hospital discharge, an expected average of 28 days
description: Length of hospital stay will be assessed (in days).
measure: ICU mortality (dysphagia vs. non-dysphagia)
time frame: Participants will be followed until hospital discharge, an expected average of 28 days
description: The incidence of mortality during ICU stay will be assessed.
measure: Hospital mortality (dysphagia vs. non-dysphagia)
time frame: Participants will be followed until hospital discharge, an expected average of 28 days
description: The incidence of mortality during hospital stay will be assessed.
arm group label: Healthy subjects
description: Healthy subjects
arm group label: Patients
description: Patients extubated after > 5 days of mechanical ventilation.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Johannes G. van der Hoeven, prof. dr.
role: Principal Investigator
affiliation: Radboud University Medical Center
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Deglutition Disorders