<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/NCT01683591</url>
  </required_header>
  <id_info>
    <org_study_id>060613</org_study_id>
    <nct_id>NCT01683591</nct_id>
  </id_info>
  <brief_title>Dysphagia Assessment in Acute Ischemic Stroke Using High-resolution Manometry</brief_title>
  <acronym>DASH</acronym>
  <official_title>Dysphagia Screening in Acute Stroke Using High-resolution Impedance Manometry (DASH); Its Implication to Diet Decision and Clinical Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Catholic University of Korea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Catholic University of Korea</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dysphagia occurs relatively commonly in patients with acute stroke, and can lead to&#xD;
      aspiration pneumonia and malnutrition. By using the stroke registry of our hospital, we will&#xD;
      evaluate the feasibility and usefulness of Dysphagia screening in Acute Stroke using&#xD;
      High-resolution impedance manometry (DASH). The hypothesis tested in this study is that&#xD;
      high-resolution impedance manometry (HRiM) can provide the clinical efficacy to evaluate&#xD;
      dysphagia and the diet plan in acute stroke patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The hypothesis tested in this study was that high-resolution manometry can provide the&#xD;
      clinical efficacy to evaluate dysphagia and the diet plan in acute stroke patients. By using&#xD;
      of stroke registry of our hospital, we assessed feasibility and usefulness of Dysphagia&#xD;
      screening in Acute Stroke using High-resolution impedance manometry in patients with acute&#xD;
      stroke.&#xD;
&#xD;
      The registry had the contents of two evaluation steps; the first step was the process to&#xD;
      identify the patients with risk of possible aspiration and the second step was for detection&#xD;
      of silent aspirators.&#xD;
&#xD;
      Firstly, the patient was interviewed regarding difficulties with food intake, chewing and&#xD;
      swallowing, and the neurological signs were confirmed by two independent neurologists. After&#xD;
      then, the patients were stratified into three aspiration risk group and controlled by proper&#xD;
      diet program. Finally the emergence of aspiration pneumonia was observed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2009</start_date>
  <completion_date type="Actual">November 2009</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement of diet program</measure>
    <time_frame>Cases were followed for the duration of hospital stay, an average of 2 weeks.</time_frame>
    <description>All patients with dysphagia received swallowing rehabilitation training and were guided as per National Dysphagia Diet level or nasogastric tube feeding. These patients were monitored in terms of the improvement of dietary program (e.g., From nasogastric tube feeding to step 4 dysphagia diet).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Occurrence of aspiration pneumonia</measure>
    <time_frame>Cases were followed for the duration of hospital stay, an average of 2 weeks.</time_frame>
    <description>All patients were monitored in terms of development of aspiration pneumonia. Aspiration pneumonia was defined as typical clinical signs (fever, sputum etc.) and chest radiographic findings (X-ray and computed tomography etc.).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall satisfaction measurement regarding program</measure>
    <time_frame>1 month after study enrollment</time_frame>
    <description>The patients also answered as visual analogue scales that measured their level of overall satisfaction regarding improvement of their symptoms with the protocol.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">293</enrollment>
  <condition>Ischemic Stroke</condition>
  <arm_group>
    <arm_group_label>High-risk aspiration group</arm_group_label>
    <description>Among the consecutive stroke patients, categorized to high-risk group in the patient (1) was not on alert mentality (from drowsy to comatose mentality), (2) was not able to sit upright or control his/her head, and (3) failed to pass indirect water swallow test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-risk aspiration group</arm_group_label>
    <description>Patents without oropharyngeal neurologic signs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intermediate-risk aspiration group</arm_group_label>
    <description>If any one of following was positive, categorized to intermediate-risk group; (1) dysarthria, (2) motor aphasia, (3) inability to close and open lips or (4) facial weakness, (5) tongue deviation or (6) uvula deviation, (7) loss of gag reflex, and (8) inability to cough voluntarily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>High-resolution impedance manometry test</intervention_name>
    <description>The test was performed as general guideline for high-resolution impedance manometry test. The parameter was obtained and analyzed using the Chicago classification for the liquid swallows with Takasaki's modification for pharyngeal function monitoring. Swallowing pattern and aspiration risk were defined using real-time assessment of high-resolution impedance manometry test.</description>
    <arm_group_label>Intermediate-risk aspiration group</arm_group_label>
    <other_name>ManoScan360 and ManoScanZ (Sierra Scientific Instruments, Los Angeles, CA).</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Acute ischemic stroke patients at neurology department from April 2009 to November 2009&#xD;
        were evaluated.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: New stroke lesion should be present in MRI which compatible with&#xD;
        clinical history and neurologic examination and patients with onset &lt;= 48 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. hyperacute stroke receiving thrombolytic therapy&#xD;
&#xD;
          2. symptom onset &gt; 48 hours&#xD;
&#xD;
          3. patients who died in the incipient stage of acute stroke&#xD;
&#xD;
          4. neurological deterioration (increase in NIHSS ≥ 4)&#xD;
&#xD;
          5. transient ischemic attack&#xD;
&#xD;
          6. history of prior stroke and dysphagia&#xD;
&#xD;
          7. other neurological diseases causing oropharyngeal dysphagia, such as Parkinsonism,&#xD;
             dementia, and neuromuscular disorders&#xD;
&#xD;
          8. history of cranial neurosurgery&#xD;
&#xD;
          9. prior or current structural lesions causing oropharyngeal dysphagia,&#xD;
&#xD;
         10. pulmonary diseases such as chronic obstructive pulmonary disease or current pneumonia.&#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>Joongseok Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Catholic University of Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 7, 2012</last_update_submitted>
  <last_update_submitted_qc>September 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Joongseok Kim</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Acute stroke</keyword>
  <keyword>Dysphagia</keyword>
  <keyword>High-resolution manometry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Stroke</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Ischemia</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/NCT01683591
org study id: 060613
nct id: NCT01683591
lead sponsor: 
has dmc: No
Dysphagia occurs relatively commonly in patients with acute stroke, and can lead to
      aspiration pneumonia and malnutrition. By using the stroke registry of our hospital, we will
      evaluate the feasibility and usefulness of Dysphagia screening in Acute Stroke using
      High-resolution impedance manometry (DASH). The hypothesis tested in this study is that
      high-resolution impedance manometry (HRiM) can provide the clinical efficacy to evaluate
      dysphagia and the diet plan in acute stroke patients.
The hypothesis tested in this study was that high-resolution manometry can provide the
      clinical efficacy to evaluate dysphagia and the diet plan in acute stroke patients. By using
      of stroke registry of our hospital, we assessed feasibility and usefulness of Dysphagia
      screening in Acute Stroke using High-resolution impedance manometry in patients with acute
      stroke.

      The registry had the contents of two evaluation steps; the first step was the process to
      identify the patients with risk of possible aspiration and the second step was for detection
      of silent aspirators.

      Firstly, the patient was interviewed regarding difficulties with food intake, chewing and
      swallowing, and the neurological signs were confirmed by two independent neurologists. After
      then, the patients were stratified into three aspiration risk group and controlled by proper
      diet program. Finally the emergence of aspiration pneumonia was observed.
observational model: Case-Only
time perspective: Retrospective
measure: Improvement of diet program
time frame: Cases were followed for the duration of hospital stay, an average of 2 weeks.
description: All patients with dysphagia received swallowing rehabilitation training and were guided as per National Dysphagia Diet level or nasogastric tube feeding. These patients were monitored in terms of the improvement of dietary program (e.g., From nasogastric tube feeding to step 4 dysphagia diet).
measure: Occurrence of aspiration pneumonia
time frame: Cases were followed for the duration of hospital stay, an average of 2 weeks.
description: All patients were monitored in terms of development of aspiration pneumonia. Aspiration pneumonia was defined as typical clinical signs (fever, sputum etc.) and chest radiographic findings (X-ray and computed tomography etc.).
measure: Overall satisfaction measurement regarding program
time frame: 1 month after study enrollment
description: The patients also answered as visual analogue scales that measured their level of overall satisfaction regarding improvement of their symptoms with the protocol.
arm group label: High-risk aspiration group
description: Among the consecutive stroke patients, categorized to high-risk group in the patient (1) was not on alert mentality (from drowsy to comatose mentality), (2) was not able to sit upright or control his/her head, and (3) failed to pass indirect water swallow test.
arm group label: Low-risk aspiration group
description: Patents without oropharyngeal neurologic signs
arm group label: Intermediate-risk aspiration group
description: If any one of following was positive, categorized to intermediate-risk group; (1) dysarthria, (2) motor aphasia, (3) inability to close and open lips or (4) facial weakness, (5) tongue deviation or (6) uvula deviation, (7) loss of gag reflex, and (8) inability to cough voluntarily.
intervention type: Procedure
intervention name: High-resolution impedance manometry test
description: The test was performed as general guideline for high-resolution impedance manometry test. The parameter was obtained and analyzed using the Chicago classification for the liquid swallows with Takasaki's modification for pharyngeal function monitoring. Swallowing pattern and aspiration risk were defined using real-time assessment of high-resolution impedance manometry test.
arm group label: Intermediate-risk aspiration group
other name: ManoScan360 and ManoScanZ (Sierra Scientific Instruments, Los Angeles, CA).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Joongseok Kim, MD, PhD
role: Principal Investigator
affiliation: The Catholic University of Korea
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Joongseok Kim
investigator title: Associate Professor
mesh term: Deglutition Disorders
mesh term: Stroke
mesh term: Ischemic Stroke
mesh term: Ischemia