<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/NCT03037762</url>
  </required_header>
  <id_info>
    <org_study_id>01072014</org_study_id>
    <nct_id>NCT03037762</nct_id>
  </id_info>
  <brief_title>Findings and Side-effects of Flexible Endoscopic Evaluation of Swallowing - the FEES-Registry</brief_title>
  <acronym>FEES-Registry</acronym>
  <official_title>Findings and Side-effects of Flexible Endoscopic Evaluation of Swallowing - the FEES-Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Muenster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Muenster</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neurogenic dysphagia is one of the most frequent and prognostically relevant neurological&#xD;
      deficits in a variety of disorders, such as stroke, parkinsonism and advanced neuromuscular&#xD;
      diseases. Flexible endoscopic evaluation of swallowing (FEES) is now probably the most&#xD;
      frequently used tool for objective dysphagia assessment in Germany. It allows evaluation of&#xD;
      the efficacy and safety of swallowing, determination of appropriate feeding strategies and&#xD;
      assessment of the efficacy of different swallowing manoeuvres. The literature furthermore&#xD;
      indicates that FEES is a safe and well-tolerated procedure. The FEES-Registry aims at&#xD;
      evaluating findings and side effects of FEES in a heterogeneous collective of patients with&#xD;
      neurogenic dysphagia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>FEES-related side effects - 1. systolic blood pressure increase</measure>
    <time_frame>during the procedure</time_frame>
    <description>Systolic blood pressure will be measured directly prior, during and after the procedure. The initial value will be compared to the highest blood pressure value measured during/directly after the procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEES-related side effects - 2. Oxygen saturation decline</measure>
    <time_frame>during the procedure</time_frame>
    <description>Oxygen saturation will be measured directly prior, during and directly after the procedure. The initial value will be compared to the lowest value measured during/directly after the procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEES-related side effects - 3. Heart rate decrease</measure>
    <time_frame>during the procedure</time_frame>
    <description>Heart rate will be measured directly prior, during and directly after the procedure. The initial value will be compared to the lowest value measured during/directly after the procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEES-related side effects - 4. Nose bleed</measure>
    <time_frame>during the procedure</time_frame>
    <description>Number of patients with nose bleed during the procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEES-related side effects - 5. Laryngospasm</measure>
    <time_frame>during the procedure</time_frame>
    <description>Number of patients with laryngospasm during the procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FEES-related side effects - 6. Decreased level of consciousness</measure>
    <time_frame>during the procedure</time_frame>
    <description>Number of patients with a decline in consciousness during the procedure (measured with the Richmond agitation and sedation scale)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patients subjective FEES-related discomfort</measure>
    <time_frame>during the procedure</time_frame>
    <description>Number of patients with procedure related discomfort measured with a 4 point scale ranging from 1=no discomfort to 4=extremely painful sensation during the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of dietary status after FEES</measure>
    <time_frame>immediately prior and immediately after the procedure</time_frame>
    <description>Dietary status will be assessed directly prior to the procedure and immediately thereafter. Dietary status will be assessed with the Functional Oral Intake Scale (FOIS scale).</description>
  </secondary_outcome>
  <enrollment type="Actual">2401</enrollment>
  <condition>Neurogenic Dysphagia</condition>
  <condition>Flexible Endoscopic Evaluation of Swallowing</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Flexible Endoscopic Evaluation of Swallowing</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with suspected neurogenic dysphagia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  suspected neurogenic dysphagia&#xD;
&#xD;
          -  Patients being scheduled for a FEES&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        - none&#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>Rainer Dziewas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Muenster, Department of Neurology, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>November 27, 2019</last_update_submitted>
  <last_update_submitted_qc>November 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2019</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>Deglutition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03037762
org study id: 01072014
nct id: NCT03037762
lead sponsor: 
has dmc: No
Neurogenic dysphagia is one of the most frequent and prognostically relevant neurological
      deficits in a variety of disorders, such as stroke, parkinsonism and advanced neuromuscular
      diseases. Flexible endoscopic evaluation of swallowing (FEES) is now probably the most
      frequently used tool for objective dysphagia assessment in Germany. It allows evaluation of
      the efficacy and safety of swallowing, determination of appropriate feeding strategies and
      assessment of the efficacy of different swallowing manoeuvres. The literature furthermore
      indicates that FEES is a safe and well-tolerated procedure. The FEES-Registry aims at
      evaluating findings and side effects of FEES in a heterogeneous collective of patients with
      neurogenic dysphagia.
observational model: Cohort
time perspective: Prospective
measure: FEES-related side effects - 1. systolic blood pressure increase
time frame: during the procedure
description: Systolic blood pressure will be measured directly prior, during and after the procedure. The initial value will be compared to the highest blood pressure value measured during/directly after the procedure.
measure: FEES-related side effects - 2. Oxygen saturation decline
time frame: during the procedure
description: Oxygen saturation will be measured directly prior, during and directly after the procedure. The initial value will be compared to the lowest value measured during/directly after the procedure.
measure: FEES-related side effects - 3. Heart rate decrease
time frame: during the procedure
description: Heart rate will be measured directly prior, during and directly after the procedure. The initial value will be compared to the lowest value measured during/directly after the procedure.
measure: FEES-related side effects - 4. Nose bleed
time frame: during the procedure
description: Number of patients with nose bleed during the procedure
measure: FEES-related side effects - 5. Laryngospasm
time frame: during the procedure
description: Number of patients with laryngospasm during the procedure
measure: FEES-related side effects - 6. Decreased level of consciousness
time frame: during the procedure
description: Number of patients with a decline in consciousness during the procedure (measured with the Richmond agitation and sedation scale)
measure: Patients subjective FEES-related discomfort
time frame: during the procedure
description: Number of patients with procedure related discomfort measured with a 4 point scale ranging from 1=no discomfort to 4=extremely painful sensation during the procedure
measure: Changes of dietary status after FEES
time frame: immediately prior and immediately after the procedure
description: Dietary status will be assessed directly prior to the procedure and immediately thereafter. Dietary status will be assessed with the Functional Oral Intake Scale (FOIS scale).
intervention type: Procedure
intervention name: Flexible Endoscopic Evaluation of Swallowing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rainer Dziewas, MD
role: Principal Investigator
affiliation: University Hospital Muenster, Department of Neurology, Germany
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Deglutition Disorders
sharing ipd: No