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/NCT05963737</url>
    </required_header>
    <id_info>
      <org_study_id>KY2023-005-02</org_study_id>
      <nct_id>NCT05963737</nct_id>
    </id_info>
    <brief_title>PMI Guide PS Setting in Pressure Support-ventilated Patients</brief_title>
    <official_title>PMI Guide PS Setting in Pressure Support-ventilated Patients - Prospective Pilot Clinical RCT</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Capital Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Capital Medical University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Pressure support ventilation (PSV) is an assistant mechanical ventilation mode, that is&#xD;
        widely implemented in mechanical ventilation treatment but there are no exact guidelines to&#xD;
        guide PS setting. Traditional PS setting strategy (VT/PBW 6-8ml/kg and RR 20-30&#xD;
        breaths/min)has risks of excessive or insufficient assistance. Inspiratory muscle pressure&#xD;
        index (PMI) is a noninvasive respiratory mechanical indicator and is available at the&#xD;
        bedside. PMI was correlated with inspiratory effort and has the potential ability to predict&#xD;
        low inspiratory effort and high inspiratory effort. The primary aim of this study is to&#xD;
        explore whether the PMI-guided PS setting strategy can shorten the duration of assisted&#xD;
        mechanical ventilation compared with the traditional PS setting strategy. Secondarily, the&#xD;
        investigators aim to explore the effects of this ventilation strategy on other mechanical&#xD;
        ventilation treatment outcomes, and whether it results in better protection of the lung and&#xD;
        diaphragm.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pressure support ventilation (PSV) is an assistant mechanical ventilation mode to provide&#xD;
        synchronous inspiratory support for patients with spontaneous breathing and to efficiently&#xD;
        reduce the workload imposed on the respiratory muscle. PSV is widely implemented in&#xD;
        mechanical ventilation treatment but there are no exact guidelines to guide PS setting.&#xD;
        Clinicians and respiratory therapists usually adjust ventilator parameters based on tidal&#xD;
        volume/predicted body weight (VT/PBW, 6-8ml/kg) and current respiratory rate (RR, 20-30&#xD;
        breaths/min). This strategy has risks of excessive or insufficient assistance because the PS&#xD;
        setting cannot be modulated dynamically based on the requirements of ventilated patients.&#xD;
  &#xD;
        Inspiratory muscle pressure index (Pmus index, PMI) is defined as the difference between&#xD;
        plateau pressure (Pplat) and airway peak pressure (Ppeak) during end-inspiratory occlusion&#xD;
        (EIO). PMI is a noninvasive respiratory mechanical indicator and is available at the bedside&#xD;
        like airway occlusion pressure (P0.1) because holding operations were integrated into the&#xD;
        majority ventilator. Several studies showed PMI was correlated with inspiratory effort. Our&#xD;
        previous study showed PMI has the potential ability to predict low inspiratory effort and&#xD;
        high inspiratory effort, and the optimal cut-off PMI value was approximately 0 cmH2O and 2&#xD;
        cmH2O.&#xD;
  &#xD;
        The primary aim of this study is to explore whether the PMI-guided PS setting strategy can&#xD;
        shorten the duration of assisted mechanical ventilation compared with the traditional PS&#xD;
        setting strategy. Secondarily, the investigators aim to explore the effects of this&#xD;
        ventilation strategy on other mechanical ventilation treatment outcomes, and whether it&#xD;
        results in better protection of the lung and diaphragm.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The duration of pressure-supported mechanical ventilation</measure>
      <time_frame>up to 28 days</time_frame>
      <description>the time from the start of PSV mode to the successful weaning of the ventilated patients</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The duration of mechanical ventilation</measure>
      <time_frame>up to 28 days</time_frame>
      <description>the time from the start of mechanical ventilaion to the successful weaning of the patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tracheostomy rate</measure>
      <time_frame>up to 28 days</time_frame>
      <description>the proportion of all subjects who underwent tracheostomy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reintubation rate</measure>
      <time_frame>up to 28 days</time_frame>
      <description>the proportion of all subjects who underwent reintubation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diaphragm thickness (Tdi)</measure>
      <time_frame>up to 28 days</time_frame>
      <description>using the Tdi to estimate the change of diaphragm function and activity during PSV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diaphragm thicken fraction (TFdi)</measure>
      <time_frame>up to 28 days</time_frame>
      <description>using the TFdi to estimate the change of diaphragm function and activity during PSV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diaphragm excursion (EXdi)</measure>
      <time_frame>up to 28 days</time_frame>
      <description>using the EXdi to estimate the change of diaphragm function and activity during PSV</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>inspiratory muscle pressure (Pmus)</measure>
      <time_frame>up to 28 days</time_frame>
      <description>measuring Pmus to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>esophageal pressure time product (PTPes)</measure>
      <time_frame>up to 28 days</time_frame>
      <description>measuring PTPes to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
      <time_frame>up to 28 days</time_frame>
      <description>treatment-related adverse events including pneumothorax, circulatory instability, etc.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">144</enrollment>
    <condition>Mechanical Ventilation</condition>
    <arm_group>
      <arm_group_label>Experimental arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The initial PS level is set up based on VT/PBW (6-8ml/kg) and RR (20-30 breaths/min) when patients are enrolled in the experimental arm. The following steps need to be repeated once per 12 hours. Step 1: 3 times short EIOs (2-3s) are performed. At least 1 minute between each occlusion. PMI is calculated as the mean value of 3 measured values. Step 2: Clarify whether PMI is in the target range (PMI 0-2cmH2O). If yes, keep this PS level. If not, implement step 3. Step 3: A downward or upward PS setting adjustment is performed at a 1cmH2O interval. Every PS level is maintained for 3-5 minutes. PMI is measured again and step 3 is repeated until the PMI target is reached. Step 4: supplemental adjustment: PS setting needs to be returned to the previous level if the patient presents the following signs: VT &lt; 4 ml/Kg, RR &gt; 35 breaths/min, respiratory acidosis, respiratory distress, VT &gt; 10ml/Kg, Pplat &gt; 30 cmH2O, respiratory alkalosis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients randomized to the control arm need to continue to accept the traditional ventilation strategy which is VT/PBW (6-8ml/kg) and RR (20-30breaths/min) guide PS setting.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PS setting strategy in pressure-support ventilated patients</intervention_name>
      <description>Use PMI guide PS setting in pressure-supported ventilated patients and keep PMI within the target range (0-2cmH2O).</description>
      <arm_group_label>Experimental arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients under PSV&#xD;
  &#xD;
            -  Predicted ventilated time of more than 48 hours.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age less than 18 years old;&#xD;
  &#xD;
            -  Known pregnancy;&#xD;
  &#xD;
            -  BMI&gt;35kg/m2;&#xD;
  &#xD;
            -  Brain-stem or cervical cord injury;&#xD;
  &#xD;
            -  Known or clinically suspected elevated intracranial pressure (ICP&gt;18 mmHg);&#xD;
  &#xD;
            -  Nervus phrenicus or diaphragm injury;&#xD;
  &#xD;
            -  Broncho-pleural fistula;&#xD;
  &#xD;
            -  Chronic obstructive pulmonary disease (COPD);&#xD;
  &#xD;
            -  Pressure support ventilated time more than 48 hours before randomization.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Beijing Tiantan Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100071</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jian-Xin Zhou, MD</last_name>
        <phone>8610 59978019</phone>
        <email>zhoujx.cn@icloud.com</email>
      </contact>
      <contact_backup>
        <last_name>Ran Gao</last_name>
        <phone>+8617647611107</phone>
        <email>1205961482@qq.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 1, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Capital Medical University</investigator_affiliation>
      <investigator_full_name>Jian-Xin Zhou</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>pressure support ventilation</keyword>
    <keyword>inspiratory effort</keyword>
    <keyword>inspiratory muscle pressure index</keyword>
    <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/NCT05963737
  org study id: KY2023-005-02
  nct id: NCT05963737
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Pressure support ventilation (PSV) is an assistant mechanical ventilation mode, that is
        widely implemented in mechanical ventilation treatment but there are no exact guidelines to
        guide PS setting. Traditional PS setting strategy (VT/PBW 6-8ml/kg and RR 20-30
        breaths/min)has risks of excessive or insufficient assistance. Inspiratory muscle pressure
        index (PMI) is a noninvasive respiratory mechanical indicator and is available at the
        bedside. PMI was correlated with inspiratory effort and has the potential ability to predict
        low inspiratory effort and high inspiratory effort. The primary aim of this study is to
        explore whether the PMI-guided PS setting strategy can shorten the duration of assisted
        mechanical ventilation compared with the traditional PS setting strategy. Secondarily, the
        investigators aim to explore the effects of this ventilation strategy on other mechanical
        ventilation treatment outcomes, and whether it results in better protection of the lung and
        diaphragm.
  Pressure support ventilation (PSV) is an assistant mechanical ventilation mode to provide
        synchronous inspiratory support for patients with spontaneous breathing and to efficiently
        reduce the workload imposed on the respiratory muscle. PSV is widely implemented in
        mechanical ventilation treatment but there are no exact guidelines to guide PS setting.
        Clinicians and respiratory therapists usually adjust ventilator parameters based on tidal
        volume/predicted body weight (VT/PBW, 6-8ml/kg) and current respiratory rate (RR, 20-30
        breaths/min). This strategy has risks of excessive or insufficient assistance because the PS
        setting cannot be modulated dynamically based on the requirements of ventilated patients.
  
        Inspiratory muscle pressure index (Pmus index, PMI) is defined as the difference between
        plateau pressure (Pplat) and airway peak pressure (Ppeak) during end-inspiratory occlusion
        (EIO). PMI is a noninvasive respiratory mechanical indicator and is available at the bedside
        like airway occlusion pressure (P0.1) because holding operations were integrated into the
        majority ventilator. Several studies showed PMI was correlated with inspiratory effort. Our
        previous study showed PMI has the potential ability to predict low inspiratory effort and
        high inspiratory effort, and the optimal cut-off PMI value was approximately 0 cmH2O and 2
        cmH2O.
  
        The primary aim of this study is to explore whether the PMI-guided PS setting strategy can
        shorten the duration of assisted mechanical ventilation compared with the traditional PS
        setting strategy. Secondarily, the investigators aim to explore the effects of this
        ventilation strategy on other mechanical ventilation treatment outcomes, and whether it
        results in better protection of the lung and diaphragm.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  measure: The duration of pressure-supported mechanical ventilation
  time frame: up to 28 days
  description: the time from the start of PSV mode to the successful weaning of the ventilated patients
  measure: The duration of mechanical ventilation
  time frame: up to 28 days
  description: the time from the start of mechanical ventilaion to the successful weaning of the patients
  measure: Tracheostomy rate
  time frame: up to 28 days
  description: the proportion of all subjects who underwent tracheostomy
  measure: Reintubation rate
  time frame: up to 28 days
  description: the proportion of all subjects who underwent reintubation
  measure: Diaphragm thickness (Tdi)
  time frame: up to 28 days
  description: using the Tdi to estimate the change of diaphragm function and activity during PSV
  measure: Diaphragm thicken fraction (TFdi)
  time frame: up to 28 days
  description: using the TFdi to estimate the change of diaphragm function and activity during PSV
  measure: Diaphragm excursion (EXdi)
  time frame: up to 28 days
  description: using the EXdi to estimate the change of diaphragm function and activity during PSV
  measure: inspiratory muscle pressure (Pmus)
  time frame: up to 28 days
  description: measuring Pmus to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration
  measure: esophageal pressure time product (PTPes)
  time frame: up to 28 days
  description: measuring PTPes to estimate the patient's inspiratory effort during the whole pressure-support ventilated duration
  measure: number of participants with treatment-related adverse events as assessed by CTCAE v4.0
  time frame: up to 28 days
  description: treatment-related adverse events including pneumothorax, circulatory instability, etc.
  arm group label: Experimental arm
  arm group type: Experimental
  description: The initial PS level is set up based on VT/PBW (6-8ml/kg) and RR (20-30 breaths/min) when patients are enrolled in the experimental arm. The following steps need to be repeated once per 12 hours. Step 1: 3 times short EIOs (2-3s) are performed. At least 1 minute between each occlusion. PMI is calculated as the mean value of 3 measured values. Step 2: Clarify whether PMI is in the target range (PMI 0-2cmH2O). If yes, keep this PS level. If not, implement step 3. Step 3: A downward or upward PS setting adjustment is performed at a 1cmH2O interval. Every PS level is maintained for 3-5 minutes. PMI is measured again and step 3 is repeated until the PMI target is reached. Step 4: supplemental adjustment: PS setting needs to be returned to the previous level if the patient presents the following signs: VT < 4 ml/Kg, RR > 35 breaths/min, respiratory acidosis, respiratory distress, VT > 10ml/Kg, Pplat > 30 cmH2O, respiratory alkalosis.
  arm group label: Control arm
  arm group type: No Intervention
  description: Patients randomized to the control arm need to continue to accept the traditional ventilation strategy which is VT/PBW (6-8ml/kg) and RR (20-30breaths/min) guide PS setting.
  intervention type: Procedure
  intervention name: PS setting strategy in pressure-support ventilated patients
  description: Use PMI guide PS setting in pressure-supported ventilated patients and keep PMI within the target range (0-2cmH2O).
  arm group label: Experimental arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Capital Medical University
  investigator full name: Jian-Xin Zhou
  investigator title: Professor
  sharing ipd: No