<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/NCT03284892</url>
  </required_header>
  <id_info>
    <org_study_id>201705051RIND</org_study_id>
    <nct_id>NCT03284892</nct_id>
  </id_info>
  <brief_title>Screening and Intervention of Postextubation Dysphagia</brief_title>
  <official_title>Screen and Intervene: A Diagnostic Accuracy Study and A Randomized, Open-label, Controlled Trial for Postextubation Dysphagia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      This clinical trial aims to test the validity of a two-item swallowing screen and to examine&#xD;
      the effects of the Swallowing and Oral-Care (SOC) Program on resumption of oral intake,&#xD;
      incidence of penetration and aspiration, and incidence of pneumonia in adult patients who&#xD;
      successfully extubated after ≥ 48 hours of endotracheal intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Endotracheal intubation is life-sustaining, but it may contribute to postextubation dysphagia&#xD;
      (PED) increasing the risk of penetration, aspiration, and aspiration pneumonia. Up to 84% of&#xD;
      extubated patients had PED and approximately 60% penetrated and aspirated that can lead to&#xD;
      aspiration pneumonia. The aims of this three-year, two-stage study are: 1) In the first&#xD;
      stage, the investigators develop a two-item swallowing screen involving oral stereognosis and&#xD;
      cough reflex test for predicting the resumption of oral intake and feeding-tube dependence by&#xD;
      using a diagnostic accuracy study method; 2) In the second stage, the investigators conduct a&#xD;
      randomized, open-label, controlled trial design to examine the effect of a once-daily, 7-day&#xD;
      SOC Program on resumption of oral intake, incidence of penetration and aspiration, and&#xD;
      incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of&#xD;
      endotracheal intubation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">August 8, 2020</completion_date>
  <primary_completion_date type="Actual">August 8, 2020</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>Qualified participants will receive a two-item screening and FEES examination within 48 hours postextubation. Then participants will be randomly assigned, on a 1:1 ratio, to an intervention, SOC group or a control group (receiving usual care). A research nurse will provide the SOC program for seven days or until death or hospital discharge. All outcomes, including resumption of oral feeding, incidence of pneumonia, and incidence of penetration and aspiration, will be evaluated by an independent outcome assessor.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>To maintain allocation concealment, the investigators ensured that only the intervention nurse had access to the random sequence. Physicians and staff at the study sites were aware of a pending nursing-intervention study but were blinded with respect to the hypothesis, group allocation, specific SOC protocols, and study endpoints. Moreover, outcome assessors were blinded to the group assignments, ensuring an unbiased evaluation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Resumption of oral feeding</measure>
    <time_frame>Postextubation 7 days</time_frame>
    <description>Measured by Functional Oral Intake Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of penetration and aspiration</measure>
    <time_frame>Time points of assessments: within 48 hrs postextubation and at the day 10 postextubation</time_frame>
    <description>Measured by the Fiberoptic endoscopic evaluation of swallowing (FEES) with optional and the study participants either opt-in or opt-out for this procedure, given that its invasive-nature procedure.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of pneumonia</measure>
    <time_frame>Postextubation 30 days</time_frame>
    <description>Abstracted from electronic medical records, based on the American Thoracic Society/Infectious Diseases Society of America criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of feeding tube dependency</measure>
    <time_frame>Postextubation 30 days</time_frame>
    <description>Abstracted from electronic medical records</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unstimulated salivary flow rate (centimeter/5 minutes)</measure>
    <time_frame>Time points of assessments: within 48 hours postextubation and at the day 10 postextubation</time_frame>
    <description>Measured by the whatman 41 test strip</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oral health status score</measure>
    <time_frame>Time points of assessments: within 48 hours postextubation and at the day 10 postextubation</time_frame>
    <description>Measured by the oral Assessment Guide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lip closure and lingual diadochokinetic status</measure>
    <time_frame>Time points of assessments: within 48 hours postextubation and at the day 10 postextubation</time_frame>
    <description>Measured by the Frenchay Dysarthria Assessment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">145</enrollment>
  <condition>Oropharyngeal Dysphagia</condition>
  <condition>Swallowing Disorder</condition>
  <condition>Randomized Controlled Trial</condition>
  <condition>Endotracheal Intubation</condition>
  <arm_group>
    <arm_group_label>SOC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Received SOC program addition to usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Received usual care only</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SOC program</intervention_name>
    <description>A once-daily, 7-day SOC program, including oral-motor exercise, sensory stimulation and lubrication, and safe-swallowing education.</description>
    <arm_group_label>SOC group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient who is over 20 years old.&#xD;
&#xD;
          -  Patient how has received over 48 hours endotracheal intubation and had been&#xD;
             successfully extubated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who has a history of neuromuscular disease (e.g., parkinsonism or stroke) or&#xD;
             head and neck deformities.&#xD;
&#xD;
          -  Patient who has preexisting difficulty swallowing.&#xD;
&#xD;
          -  Patient who has received a tracheostomy.&#xD;
&#xD;
          -  Patient who were unable to follow verbal instructions.&#xD;
&#xD;
          -  Patient who were on contact and droplet precautions (e.g., open tuberculosis)&#xD;
&#xD;
          -  Patient who were receiving continuous noninvasive ventilation after extubation that&#xD;
             precluded the delivery of an SOC intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cheryl Chia-Hui Chen, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Nursing, College of Medicine, National Taiwan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10055</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>postextubation dysphagia</keyword>
  <keyword>endotracheal intubation</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>dysphagia intervention</keyword>
  <keyword>dysphagia screening</keyword>
  <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>Undecided</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/NCT03284892
org study id: 201705051RIND
nct id: NCT03284892
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This clinical trial aims to test the validity of a two-item swallowing screen and to examine
      the effects of the Swallowing and Oral-Care (SOC) Program on resumption of oral intake,
      incidence of penetration and aspiration, and incidence of pneumonia in adult patients who
      successfully extubated after ≥ 48 hours of endotracheal intubation.
Endotracheal intubation is life-sustaining, but it may contribute to postextubation dysphagia
      (PED) increasing the risk of penetration, aspiration, and aspiration pneumonia. Up to 84% of
      extubated patients had PED and approximately 60% penetrated and aspirated that can lead to
      aspiration pneumonia. The aims of this three-year, two-stage study are: 1) In the first
      stage, the investigators develop a two-item swallowing screen involving oral stereognosis and
      cough reflex test for predicting the resumption of oral intake and feeding-tube dependence by
      using a diagnostic accuracy study method; 2) In the second stage, the investigators conduct a
      randomized, open-label, controlled trial design to examine the effect of a once-daily, 7-day
      SOC Program on resumption of oral intake, incidence of penetration and aspiration, and
      incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of
      endotracheal intubation.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Qualified participants will receive a two-item screening and FEES examination within 48 hours postextubation. Then participants will be randomly assigned, on a 1:1 ratio, to an intervention, SOC group or a control group (receiving usual care). A research nurse will provide the SOC program for seven days or until death or hospital discharge. All outcomes, including resumption of oral feeding, incidence of pneumonia, and incidence of penetration and aspiration, will be evaluated by an independent outcome assessor.
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
masking description: To maintain allocation concealment, the investigators ensured that only the intervention nurse had access to the random sequence. Physicians and staff at the study sites were aware of a pending nursing-intervention study but were blinded with respect to the hypothesis, group allocation, specific SOC protocols, and study endpoints. Moreover, outcome assessors were blinded to the group assignments, ensuring an unbiased evaluation.
measure: Resumption of oral feeding
time frame: Postextubation 7 days
description: Measured by Functional Oral Intake Scale
measure: Incidence of penetration and aspiration
time frame: Time points of assessments: within 48 hrs postextubation and at the day 10 postextubation
description: Measured by the Fiberoptic endoscopic evaluation of swallowing (FEES) with optional and the study participants either opt-in or opt-out for this procedure, given that its invasive-nature procedure.
measure: Incidence of pneumonia
time frame: Postextubation 30 days
description: Abstracted from electronic medical records, based on the American Thoracic Society/Infectious Diseases Society of America criteria.
measure: Incidence of feeding tube dependency
time frame: Postextubation 30 days
description: Abstracted from electronic medical records
measure: Unstimulated salivary flow rate (centimeter/5 minutes)
time frame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
description: Measured by the whatman 41 test strip
measure: Oral health status score
time frame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
description: Measured by the oral Assessment Guide
measure: Lip closure and lingual diadochokinetic status
time frame: Time points of assessments: within 48 hours postextubation and at the day 10 postextubation
description: Measured by the Frenchay Dysarthria Assessment
arm group label: SOC group
arm group type: Experimental
description: Received SOC program addition to usual care
arm group label: Control group
arm group type: No Intervention
description: Received usual care only
intervention type: Behavioral
intervention name: SOC program
description: A once-daily, 7-day SOC program, including oral-motor exercise, sensory stimulation and lubrication, and safe-swallowing education.
arm group label: SOC group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Cheryl Chia-Hui Chen, Prof.
role: Principal Investigator
affiliation: School of Nursing, College of Medicine, National Taiwan University
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Deglutition Disorders
sharing ipd: Undecided