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/NCT05996055</url>
    </required_header>
    <id_info>
      <org_study_id>202303134DINA</org_study_id>
      <nct_id>NCT05996055</nct_id>
    </id_info>
    <brief_title>A Comparative Study of Support Devices for Ventilator-Assisted ICU Patients</brief_title>
    <official_title>Comparison of the Benefits of Different Types of Wearable Respirator Support Devices for Critically Ill Patients in the ICU During Early Mobilization</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Assisting critically ill patients with early mobilization or early ambulation during their&#xD;
        stay in the intensive care unit (ICU) can reduce the duration of mechanical ventilation use,&#xD;
        length of ICU or hospital stay, probability of complications during hospitalization, and&#xD;
        sedation days in the ICU and improve disease prognosis. However, over 80% of critically ill&#xD;
        patients have endotracheal tubes and require the use of mechanical ventilators in the ICU,&#xD;
        and due to the numerous invasive treatments and tubes, there are high concerns regarding the&#xD;
        safety of tube stability and risk of tube dislodgement during early mobilization. Although&#xD;
        there are commercially available fixed tracheal tubes or external support devices for&#xD;
        breathing tubes to prevent displacement, they do not solve the problems of the weight of the&#xD;
        breathing tube during ambulation or endotracheal tube slippage. Therefore, through&#xD;
        interdisciplinary collaboration, the investigator has designed a &quot;wearable support device&quot;&#xD;
        (Type A support device). The unique design of the fixed frame uses a plug-in-latch shape to&#xD;
        fix the Y-shaped breathing tube to the patient's chest position. In addition to reducing the&#xD;
        displacement of the free section of the endotracheal tube downwards, it can also fix the main&#xD;
        body of the breathing tube. The dual-disc strap method allows adjustment of the position and&#xD;
        tightness for patients of different body sizes, and a single specification can be used for&#xD;
        patients of various body shapes. Currently, a modified version of this wearable support&#xD;
        device (Type B support device) has been designed based on clinical suggestions.The purpose of&#xD;
        this study is to compare the feasibility, safety, and comfort of using the Type A-support&#xD;
        device and the Type B-support device to assist in supporting breathing tubes during early&#xD;
        ambulation in ICU patients using mechanical ventilators.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">July 31, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2024</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>Crossover Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>wearing time</measure>
      <time_frame>From date of randomization up to 5 days</time_frame>
      <description>the time taken to wear support device</description>
    </primary_outcome>
    <primary_outcome>
      <measure>removal time</measure>
      <time_frame>From date of randomization up to 5 days</time_frame>
      <description>the time taken to remove support device</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>5-min heart rate variability (HRV)</measure>
      <time_frame>From date of randomization up to 5 days</time_frame>
      <description>including low-to-high-frequency power ratio (LF/HF) and standard deviation of NN intervals(SDNN)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mean values of the rapid shallow breathing index (RSBI)</measure>
      <time_frame>From date of randomization up to 5 days</time_frame>
      <description>recorded the ratio of respiratory rate (RR) and tidal volume (VT) and calulated by RR to VT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>user self-reported function, and device satisfaction</measure>
      <time_frame>From date of randomization up to 5 days</time_frame>
      <description>self-made questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>adverse event</measure>
      <time_frame>From date of randomization up to 5 days</time_frame>
      <description>Observe the abnormality of the skin on the chest/back of the base plate before and after wearing it; Record the number of incidents of accidental slippage of the external oral line while performing early ambulation while wearing the support device.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Device Dislocation</condition>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>initially using the Type A device (the NTUH version_support device)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>initially using the Type B device (improved version_support device)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>improved version_support device</intervention_name>
      <description>designed the NTUH version_support device based on the clinical suggestion.</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>experimental group</arm_group_label>
      <other_name>type B support device</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>the NTUH version_support device</intervention_name>
      <description>original designed by NTUH</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>experimental group</arm_group_label>
      <other_name>type A support device</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Glasgow Coma Scale score of ≥6,&#xD;
  &#xD;
            2. relatively stable respiratory status (oxygen saturation &gt;92%, settings on the&#xD;
               mechanical ventilator: fraction of inspired oxygen ≤60%, positive end-expiratory&#xD;
               pressure ≤10 cmH2O)&#xD;
  &#xD;
            3. a stable cardiovascular system (resting heart rate ≤130 and &gt;40 beats per minute)&#xD;
  &#xD;
            4. no requirement for high-dose vasopressors &gt;0.2 μg/kg/min).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with temporary limb immobilization as prescribed by the physician.&#xD;
  &#xD;
            2. Patients with a tendency to bleed.&#xD;
  &#xD;
            3. Patients with pre-existing mental abnormalities.&#xD;
  &#xD;
            4. Patients who are expected to die within the next 24 hours or are primarily receiving&#xD;
               palliative care in the intensive care unit.&#xD;
  &#xD;
            5. Patients with sustained intracranial pressure elevation (&gt; 20 millimeters of mercury&#xD;
               (mmHg)).&#xD;
  &#xD;
            6. Pregnant patients.&#xD;
  &#xD;
            7. Uncontrolled epilepsy.&#xD;
  &#xD;
            8. Acute myocardial infarction or rapidly progressing neuromuscular diseases occurring in&#xD;
               the intensive care unit.&#xD;
  &#xD;
            9. Patients with abnormal skin conditions such as skin abrasions, redness, swelling,&#xD;
               etc., in the chest/back area.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hung-Jui Chuang, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Taiwan University Hospital, Taipei, Taiwan</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Taiwan University Hospital</name>
        <address>
          <city>Taipei</city>
          <state>Zhongzheng</state>
          <zip>110</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Intensive unit care</keyword>
    <keyword>Early mobilization</keyword>
    <keyword>Mechanical ventilation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Joint Dislocations</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05996055
  org study id: 202303134DINA
  nct id: NCT05996055
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Assisting critically ill patients with early mobilization or early ambulation during their
        stay in the intensive care unit (ICU) can reduce the duration of mechanical ventilation use,
        length of ICU or hospital stay, probability of complications during hospitalization, and
        sedation days in the ICU and improve disease prognosis. However, over 80% of critically ill
        patients have endotracheal tubes and require the use of mechanical ventilators in the ICU,
        and due to the numerous invasive treatments and tubes, there are high concerns regarding the
        safety of tube stability and risk of tube dislodgement during early mobilization. Although
        there are commercially available fixed tracheal tubes or external support devices for
        breathing tubes to prevent displacement, they do not solve the problems of the weight of the
        breathing tube during ambulation or endotracheal tube slippage. Therefore, through
        interdisciplinary collaboration, the investigator has designed a "wearable support device"
        (Type A support device). The unique design of the fixed frame uses a plug-in-latch shape to
        fix the Y-shaped breathing tube to the patient's chest position. In addition to reducing the
        displacement of the free section of the endotracheal tube downwards, it can also fix the main
        body of the breathing tube. The dual-disc strap method allows adjustment of the position and
        tightness for patients of different body sizes, and a single specification can be used for
        patients of various body shapes. Currently, a modified version of this wearable support
        device (Type B support device) has been designed based on clinical suggestions.The purpose of
        this study is to compare the feasibility, safety, and comfort of using the Type A-support
        device and the Type B-support device to assist in supporting breathing tubes during early
        ambulation in ICU patients using mechanical ventilators.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: wearing time
  time frame: From date of randomization up to 5 days
  description: the time taken to wear support device
  measure: removal time
  time frame: From date of randomization up to 5 days
  description: the time taken to remove support device
  measure: 5-min heart rate variability (HRV)
  time frame: From date of randomization up to 5 days
  description: including low-to-high-frequency power ratio (LF/HF) and standard deviation of NN intervals(SDNN)
  measure: mean values of the rapid shallow breathing index (RSBI)
  time frame: From date of randomization up to 5 days
  description: recorded the ratio of respiratory rate (RR) and tidal volume (VT) and calulated by RR to VT
  measure: user self-reported function, and device satisfaction
  time frame: From date of randomization up to 5 days
  description: self-made questionnaire
  measure: adverse event
  time frame: From date of randomization up to 5 days
  description: Observe the abnormality of the skin on the chest/back of the base plate before and after wearing it; Record the number of incidents of accidental slippage of the external oral line while performing early ambulation while wearing the support device.
  arm group label: control group
  arm group type: Active Comparator
  description: initially using the Type A device (the NTUH version_support device)
  arm group label: experimental group
  arm group type: Experimental
  description: initially using the Type B device (improved version_support device)
  intervention type: Device
  intervention name: improved version_support device
  description: designed the NTUH version_support device based on the clinical suggestion.
  arm group label: control group
  arm group label: experimental group
  other name: type B support device
  intervention type: Device
  intervention name: the NTUH version_support device
  description: original designed by NTUH
  arm group label: control group
  arm group label: experimental group
  other name: type A support device
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Hung-Jui Chuang, Dr
  role: Principal Investigator
  affiliation: National Taiwan University Hospital, Taipei, Taiwan
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Joint Dislocations
  sharing ipd: No