xml: <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/NCT05999786</url>
    </required_header>
    <id_info>
      <org_study_id>202303005RIND</org_study_id>
      <nct_id>NCT05999786</nct_id>
    </id_info>
    <brief_title>ERAS Swallowing Rehabilitation in Elder Patients</brief_title>
    <official_title>Effectivity of Early Recovery Accelerated Swallowing Program on Promoting Swallowing Recovery in Older Patients With High Risk of Oral Frailty Requiring Endotracheal Intubation During General Anesthesia: a Pilot Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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>
        The investigators studied that swallowing function of patients receiving the Early Recovery&#xD;
        Accelerated Swallowing (ERAS-W program) training will recover fast than that of patients in&#xD;
        the control group. The ERAS program training will be initiated before surgery and continue to&#xD;
        after surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The older patients (≥65 years old) with OFI-8≥4 undergoing elective orthopedic surgery&#xD;
        requiring tracheal intubation will be recruited. Patients will be randomized into an&#xD;
        intervention and a control group. Patients in the intervention groups will received the&#xD;
        ERAS-W program, while those in the control group will receive the swallowing education video.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 10, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2030</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2028</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>Patients receive early recovery of swallowing rehabiliation before surgery and continued to after surgery</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Data manager knows whether the patients are in the intervention or control group. However, the patients, caregiver, investigator, and outcome assessors do not know whether the patients are in the intervention or control group.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>UES pressure, mmHg</measure>
      <time_frame>about six months</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>The Upper Esophageal Sphincter Contraction Strength</condition>
    <arm_group>
      <arm_group_label>patients receiving early rehabiliation swallowing program</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>the early rehabilitation program beginning from before to after surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>patients not receiving early rehabilitation swallowing program</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>the Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is started from before to after surgery</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>early rehabiliation swallowing program</intervention_name>
      <description>not receiving early rehabilitation swallowing program from before and after surgery</description>
      <arm_group_label>patients receiving early rehabiliation swallowing program</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>not receiving early rehabilitation swallowing program</intervention_name>
      <description>the Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is from before and after surgery</description>
      <arm_group_label>patients not receiving early rehabilitation swallowing program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  elective surgery&#xD;
  &#xD;
            -  general anesthesia with endotracheal intubation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  major organ dysfunction, ex: chronic kidney disease, hear failure&#xD;
  &#xD;
            -  bleeding tendency&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Chih-Min Liu, MD</last_name>
      <phone>_886-972652224</phone>
      <email>lewisliu@ntuh.gov.tw</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Chih-Jun Lai, MD</last_name>
      <phone>+886-972652086</phone>
      <email>littlecherrytw@gmail.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
      <investigator_full_name>National Taiwan University Clinical Trial Center</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>due to ethical problem</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05999786
  org study id: 202303005RIND
  nct id: NCT05999786
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The investigators studied that swallowing function of patients receiving the Early Recovery
        Accelerated Swallowing (ERAS-W program) training will recover fast than that of patients in
        the control group. The ERAS program training will be initiated before surgery and continue to
        after surgery.
  The older patients (≥65 years old) with OFI-8≥4 undergoing elective orthopedic surgery
        requiring tracheal intubation will be recruited. Patients will be randomized into an
        intervention and a control group. Patients in the intervention groups will received the
        ERAS-W program, while those in the control group will receive the swallowing education video.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients receive early recovery of swallowing rehabiliation before surgery and continued to after surgery
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Data manager knows whether the patients are in the intervention or control group. However, the patients, caregiver, investigator, and outcome assessors do not know whether the patients are in the intervention or control group.
  measure: UES pressure, mmHg
  time frame: about six months
  arm group label: patients receiving early rehabiliation swallowing program
  arm group type: Active Comparator
  description: the early rehabilitation program beginning from before to after surgery
  arm group label: patients not receiving early rehabilitation swallowing program
  arm group type: Placebo Comparator
  description: the Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is started from before to after surgery
  intervention type: Behavioral
  intervention name: early rehabiliation swallowing program
  description: not receiving early rehabilitation swallowing program from before and after surgery
  arm group label: patients receiving early rehabiliation swallowing program
  intervention type: Behavioral
  intervention name: not receiving early rehabilitation swallowing program
  description: the Taiwan Dysphagia Society's publicly shared swallowing exercises for dysphagia, which is from before and after surgery
  arm group label: patients not receiving early rehabilitation swallowing program
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Chih-Min Liu, MD
  phone: _886-972652224
  email: lewisliu@ntuh.gov.tw
  last name: Chih-Jun Lai, MD
  phone: +886-972652086
  email: littlecherrytw@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: National Taiwan University Hospital
  investigator full name: National Taiwan University Clinical Trial Center
  investigator title: Principal Investigator
  sharing ipd: No
  ipd description: due to ethical problem