<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/NCT03753841</url>
  </required_header>
  <id_info>
    <org_study_id>GI 208/16-1</org_study_id>
    <nct_id>NCT03753841</nct_id>
  </id_info>
  <brief_title>FEES to Determine Neurological Intensive Care Patients' Oral Diet</brief_title>
  <official_title>Flexible Endoscopic Evaluation of Swallowing (FEES) to Determine Neurological Patients' Oral Diet</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Giessen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Giessen</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>
      Dysphagia is associated with high rates of mortality and morbidity. Adjusting the oral diet&#xD;
      of ICU-patients based on flexible endoscopic evaluation of swallowing (FEES) findings might&#xD;
      reduce pneumonia rate, mortality and need for intubation/tracheotomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dysphagia, a common complication in neurological disorders, leads to high rates of mortality&#xD;
      and morbidity. It is prevalent in critically ill patients, especially those who need&#xD;
      mechanical ventilation. The investigators therefore investigate the effect of adjusting the&#xD;
      oral diet of our intensive care unit (ICU) patients based on flexible endoscopic evaluation&#xD;
      of swallowing (FEES) findings, thereby assessing the impact of FEES on a neurological ICU.&#xD;
      All patients treated on the investigators neurological ICU will be eligible for this study.&#xD;
&#xD;
      The investigators will correlate findings with baseline data, disability status, pneumonia&#xD;
      and duration of hospitalisation, as well as a need for mechanical ventilation or a&#xD;
      tracheotomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2014</start_date>
  <completion_date type="Actual">September 16, 2016</completion_date>
  <primary_completion_date type="Actual">September 3, 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pneumonia Rate</measure>
    <time_frame>Up to 130 days</time_frame>
    <description>self-explanatory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>Up to 130 days</time_frame>
    <description>self-explanatory</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay in hospital</measure>
    <time_frame>Up to 130 days</time_frame>
    <description>self-explanatory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubation/Tracheotomy</measure>
    <time_frame>Up to 130 days</time_frame>
    <description>Rate of Intubation/Tracheotomy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Dysphagia</condition>
  <condition>Aspiration Pneumonia</condition>
  <condition>Deglutition Disorders</condition>
  <condition>Intensive Care Neurological Disorder</condition>
  <arm_group>
    <arm_group_label>Adjustment of oral diet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients who need a change in their diet regime, in whom FEES shows that they have not the adequat diet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No adjustment of oral diet</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients who have the adequat diet based on FEES findings.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adjustment of oral diet</intervention_name>
    <description>Adjustment of oral diet based on findings in fiberendoscopic evaluation of swallowing (FEES)</description>
    <arm_group_label>Adjustment of oral diet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Treatment on neurological ICU&#xD;
&#xD;
          -  Clinical suspicion of Dysphagia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tobias Braun, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Giessen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universitätsklinikum Gießen</name>
      <address>
        <city>Gießen</city>
        <state>Hessen</state>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 22, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 22, 2018</last_update_submitted>
  <last_update_submitted_qc>November 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Giessen</investigator_affiliation>
    <investigator_full_name>Tobias Braun</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Dysphagia</keyword>
  <keyword>Aspiration</keyword>
  <keyword>Management of Dysphagia</keyword>
  <keyword>Deglutition Disorders</keyword>
  <keyword>Deglutition</keyword>
  <keyword>FEES</keyword>
  <keyword>Intensive Care Neurological Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia, Aspiration</mesh_term>
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The authors declare that the data supporting the findings of this study will be available within the published article(s). The data that support the findings of this study will not be publically available due to local medical data protection policies.</ipd_description>
  </patient_data>
  <!-- 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/NCT03753841
org study id: GI 208/16-1
nct id: NCT03753841
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Dysphagia is associated with high rates of mortality and morbidity. Adjusting the oral diet
      of ICU-patients based on flexible endoscopic evaluation of swallowing (FEES) findings might
      reduce pneumonia rate, mortality and need for intubation/tracheotomy.
Dysphagia, a common complication in neurological disorders, leads to high rates of mortality
      and morbidity. It is prevalent in critically ill patients, especially those who need
      mechanical ventilation. The investigators therefore investigate the effect of adjusting the
      oral diet of our intensive care unit (ICU) patients based on flexible endoscopic evaluation
      of swallowing (FEES) findings, thereby assessing the impact of FEES on a neurological ICU.
      All patients treated on the investigators neurological ICU will be eligible for this study.

      The investigators will correlate findings with baseline data, disability status, pneumonia
      and duration of hospitalisation, as well as a need for mechanical ventilation or a
      tracheotomy.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pneumonia Rate
time frame: Up to 130 days
description: self-explanatory
measure: Mortality
time frame: Up to 130 days
description: self-explanatory
measure: Length of stay in hospital
time frame: Up to 130 days
description: self-explanatory
measure: Intubation/Tracheotomy
time frame: Up to 130 days
description: Rate of Intubation/Tracheotomy
arm group label: Adjustment of oral diet
arm group type: Active Comparator
description: Patients who need a change in their diet regime, in whom FEES shows that they have not the adequat diet.
arm group label: No adjustment of oral diet
arm group type: No Intervention
description: Patients who have the adequat diet based on FEES findings.
intervention type: Other
intervention name: Adjustment of oral diet
description: Adjustment of oral diet based on findings in fiberendoscopic evaluation of swallowing (FEES)
arm group label: Adjustment of oral diet
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Tobias Braun, M.D.
role: Principal Investigator
affiliation: University of Giessen
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University of Giessen
investigator full name: Tobias Braun
investigator title: Principal Investigator
mesh term: Pneumonia, Aspiration
mesh term: Deglutition Disorders
mesh term: Nervous System Diseases
sharing ipd: No
ipd description: The authors declare that the data supporting the findings of this study will be available within the published article(s). The data that support the findings of this study will not be publically available due to local medical data protection policies.