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/NCT05970393</url>
    </required_header>
    <id_info>
      <org_study_id>KY2023-001-02</org_study_id>
      <nct_id>NCT05970393</nct_id>
    </id_info>
    <brief_title>Inspiratory Contribution of Pressure Support-ventilated Patients in Different PMI Conditions</brief_title>
    <official_title>Inspiratory Contribution of Pressure Support-ventilated Patients in Different PMI Conditions - a Prospective Physiological Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jian-Xin Zhou</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 assisted mechanical ventilation mode that provides&#xD;
        synchronous inspiratory support for patients with spontaneous breathing. PSV divides the work&#xD;
        involved in producing ventilation between the ventilator and the patients. The patient&#xD;
        inspiratory effort needs close monitoring to avoid inappropriate assistance and maintain&#xD;
        favorable patient-ventilator interaction during PSV. Esophageal pressure (Pes)-derived&#xD;
        parameters are regarded as golden indicators of inspiratory effort. Based on this&#xD;
        precondition, the fraction of PTP generated by the patient during PSV (PTP ratio) can&#xD;
        evaluate the inspiratory contribution proportion of ventilated patients with spontaneous&#xD;
        breathing. Inspiratory muscle pressure index (PMI) was confirmed to be associated with&#xD;
        inspiratory effort and can effectively predict low/high effort. The study tries to explore&#xD;
        the relationship between PMI and PTP ratio and find the optimal cut-off value of PMI to&#xD;
        predict different PTP ratios. Second, investigators want to verify the safety and validity of&#xD;
        PMI-guided PS settings for pressure-support ventilated patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pressure support ventilation (PSV) is an assisted mechanical ventilation mode that provides&#xD;
        synchronous inspiratory support for patients with spontaneous breathing. PSV divides the work&#xD;
        involved in producing ventilation between the ventilator and the patients. The level of&#xD;
        support should be adjusted to the patient's inspiratory effort for assisted ventilation to be&#xD;
        successful. Despite PSV being commonly used in mechanical ventilation therapy, the PS setting&#xD;
        is not precisely regulated. Clinicians and respiratory therapists typically use tidal&#xD;
        volume/predicted body weight (VT/PBW, 6-8 ml/Kg) and respiratory rate (RR, 20-30 breaths/min)&#xD;
        to modify ventilator settings. Because pressure support level is not dynamically modulated&#xD;
        based on the inspiratory effort of ventilated patients in time, there is always the risk of&#xD;
        excessive or insufficient assistance. Excessive assistance and low inspiratory effort may&#xD;
        result in diaphragm disuse atrophy and ventilator-induced lung injury (VILI). Inadequate&#xD;
        assistance and high inspiratory effort may result in diagram stretched injury and&#xD;
        patient-inflicted lung injury (PSILI). Both situations cause strain and stress on the lung&#xD;
        and diaphragm, which may influence the ICU clinical outcomes.&#xD;
  &#xD;
        The patient inspiratory effort needs close monitoring to avoid inappropriate assistance and&#xD;
        maintain favorable patient-ventilator interaction during PSV. Esophageal pressure&#xD;
        (Pes)-derived parameters are regarded as golden indicators of inspiratory effort, including&#xD;
        respiratory muscle pressure (Pmus), esophageal pressure-time product (PTPes), etc. Based on&#xD;
        this precondition, the fraction of PTP generated by the patient during PSV (PTP ratio) can&#xD;
        evaluate the inspiratory contribution proportion of ventilated patients with spontaneous&#xD;
        breathing. Pmus index (PMI) is defined as the change in airway pressure (Paw) during the&#xD;
        end-inspiratory occlusion and represents the patient's current elastic workload. This&#xD;
        variable was confirmed to be associated with inspiratory effort and can effectively predict&#xD;
        low/high effort. More importantly, it is non-invasive and available at the bedside because&#xD;
        respiratory hold operations are integrated into most ventilators. However, the relationship&#xD;
        between PMI and the inspiratory contribution proportion of ventilated patients is not clear,&#xD;
        and how to guide PS settings through PMI needs more research.&#xD;
  &#xD;
        Our study aims to explore the inspiratory contribution of pressure-support ventilated&#xD;
        patients in different PMI conditions. In other words, investigators try to explore the&#xD;
        relationship between PMI and PTP ratio and find the optimal cut-off value of PMI to predict&#xD;
        different PTP ratios. Second, investigators want to verify the safety and validity of&#xD;
        PMI-guided PS settings for pressure-support ventilated patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 7, 2023</start_date>
    <completion_date type="Anticipated">August 7, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 7, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The correlation between PMI and PTP ratio</measure>
      <time_frame>3 hours</time_frame>
      <description>Regression was conducted by the linear mixed-effects model with patients managed as random effects. The correlation between PMI and PTP ratio was evaluated as the coefficient of determination (R2).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The ability of PMI to detect different PTP ratios</measure>
      <time_frame>3 hours</time_frame>
      <description>The ability of PMI to detect different inspiratory effort contribution proportions was assessed using the Area Under the Receiver-Operating-Characteristics Curve (AUROC). The optimal cut-off values were selected based on the Youden index.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Tidal volume per predicted body weight (VT/PBW, ml/Kg)</measure>
      <time_frame>3 hours</time_frame>
      <description>We use the VT/PBW (ml/Kg) as lung-protective ventilation safety makers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory rate (RR, circle/min)</measure>
      <time_frame>3 hours</time_frame>
      <description>We use the RR (circle/min) as lung-protective ventilation safety makers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Transpulmonary driving pressure (DPlung, cmH2O)</measure>
      <time_frame>3 hours</time_frame>
      <description>We use the DPlung (cmH2O) as lung-protective ventilation safety makers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory driving pressure (DPrs, cmH2O)</measure>
      <time_frame>3 hours</time_frame>
      <description>We use the DPrs (cmH2O) as lung-protective ventilation safety makers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory muscle pressure (Pmus, cmH2O)</measure>
      <time_frame>3 hours</time_frame>
      <description>Our study chose Pmus (cmH2O) as the golden standard of inspiratory effort to estimate the validity of PMI-guided PS setting.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Esophageal pressure-time product (PTPes, cmH2O)</measure>
      <time_frame>3 hours</time_frame>
      <description>Our study chose PTPes (cmH2O) as the golden standard of inspiratory effort to estimate the validity of PMI-guided PS setting.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Mechanical Ventilation</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>pressure support level tatrition</intervention_name>
      <description>Baseline ventilators were set by the principle of keeping VT/PBW at 6-8ml/kg and RR at 20-30 breaths/min and the decision of the responsible ICU physician. After then the fraction of inspired oxygen (FiO2), positive expiratory end pressure (PEEP), trigger sensitivity, and cycle-off criteria remain unchanged. Upward and downward PS level adjustments were performed from the baseline PS level at a 1cm H2O interval. Every PS level was maintained for 20 minutes and then three end-inspiratory holdings (2-3seconds) and three end-expiratory holdings were performed. PMI mean value was measured and calculated at every PS level. To avoid additional injury to the lung and diaphragm, the airway peak pressure (Ppeak) was limited to 30cmH2O, and titrating PS was stopped until PMI was less than -1cmH2O and more than 3cmH2O.The inspiratory effort is measured as the pressure generated by inspiratory muscles using esophageal pressure monitoring.</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Adult acute respiratory failure patients undergoing mechanical ventilation were screened&#xD;
          daily and enrolled 24 hours after switching to PSV mode.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. age younger than 18 years old and more than 80 years old&#xD;
  &#xD;
            2. chronic occlusive pulmonary diseases&#xD;
  &#xD;
            3. known pregnancy and parturient&#xD;
  &#xD;
            4. gastric, esophageal, and diaphragm surgery&#xD;
  &#xD;
            5. barotrauma&#xD;
  &#xD;
            6. neuromuscular diseases&#xD;
  &#xD;
            7. intracranial hypertension and brain stem injury&#xD;
  &#xD;
            8. consciousness level decreased (SAS less than 3 scores)&#xD;
  &#xD;
            9. Anticipating withdrawal of life support and/or shift to palliation as the goal of&#xD;
               care.&#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_contact>
      <last_name>Jian-Xin Zhou, MD</last_name>
      <phone>8610 63926888</phone>
      <email>zhoujx.cn@icloud.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ran Gao, MD</last_name>
      <phone>+8617647611107</phone>
      <email>1205961482@qq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Beijing Tiantan Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ran Gao, MD</last_name>
        <phone>+8617647611107</phone>
        <email>1205961482@qq.com</email>
      </contact>
    </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 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Aspiration</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/NCT05970393
  org study id: KY2023-001-02
  nct id: NCT05970393
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Pressure support ventilation (PSV) is an assisted mechanical ventilation mode that provides
        synchronous inspiratory support for patients with spontaneous breathing. PSV divides the work
        involved in producing ventilation between the ventilator and the patients. The patient
        inspiratory effort needs close monitoring to avoid inappropriate assistance and maintain
        favorable patient-ventilator interaction during PSV. Esophageal pressure (Pes)-derived
        parameters are regarded as golden indicators of inspiratory effort. Based on this
        precondition, the fraction of PTP generated by the patient during PSV (PTP ratio) can
        evaluate the inspiratory contribution proportion of ventilated patients with spontaneous
        breathing. Inspiratory muscle pressure index (PMI) was confirmed to be associated with
        inspiratory effort and can effectively predict low/high effort. The study tries to explore
        the relationship between PMI and PTP ratio and find the optimal cut-off value of PMI to
        predict different PTP ratios. Second, investigators want to verify the safety and validity of
        PMI-guided PS settings for pressure-support ventilated patients.
  Pressure support ventilation (PSV) is an assisted mechanical ventilation mode that provides
        synchronous inspiratory support for patients with spontaneous breathing. PSV divides the work
        involved in producing ventilation between the ventilator and the patients. The level of
        support should be adjusted to the patient's inspiratory effort for assisted ventilation to be
        successful. Despite PSV being commonly used in mechanical ventilation therapy, the PS setting
        is not precisely regulated. Clinicians and respiratory therapists typically use tidal
        volume/predicted body weight (VT/PBW, 6-8 ml/Kg) and respiratory rate (RR, 20-30 breaths/min)
        to modify ventilator settings. Because pressure support level is not dynamically modulated
        based on the inspiratory effort of ventilated patients in time, there is always the risk of
        excessive or insufficient assistance. Excessive assistance and low inspiratory effort may
        result in diaphragm disuse atrophy and ventilator-induced lung injury (VILI). Inadequate
        assistance and high inspiratory effort may result in diagram stretched injury and
        patient-inflicted lung injury (PSILI). Both situations cause strain and stress on the lung
        and diaphragm, which may influence the ICU clinical outcomes.
  
        The patient inspiratory effort needs close monitoring to avoid inappropriate assistance and
        maintain favorable patient-ventilator interaction during PSV. Esophageal pressure
        (Pes)-derived parameters are regarded as golden indicators of inspiratory effort, including
        respiratory muscle pressure (Pmus), esophageal pressure-time product (PTPes), etc. Based on
        this precondition, the fraction of PTP generated by the patient during PSV (PTP ratio) can
        evaluate the inspiratory contribution proportion of ventilated patients with spontaneous
        breathing. Pmus index (PMI) is defined as the change in airway pressure (Paw) during the
        end-inspiratory occlusion and represents the patient's current elastic workload. This
        variable was confirmed to be associated with inspiratory effort and can effectively predict
        low/high effort. More importantly, it is non-invasive and available at the bedside because
        respiratory hold operations are integrated into most ventilators. However, the relationship
        between PMI and the inspiratory contribution proportion of ventilated patients is not clear,
        and how to guide PS settings through PMI needs more research.
  
        Our study aims to explore the inspiratory contribution of pressure-support ventilated
        patients in different PMI conditions. In other words, investigators try to explore the
        relationship between PMI and PTP ratio and find the optimal cut-off value of PMI to predict
        different PTP ratios. Second, investigators want to verify the safety and validity of
        PMI-guided PS settings for pressure-support ventilated patients.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: The correlation between PMI and PTP ratio
  time frame: 3 hours
  description: Regression was conducted by the linear mixed-effects model with patients managed as random effects. The correlation between PMI and PTP ratio was evaluated as the coefficient of determination (R2).
  measure: The ability of PMI to detect different PTP ratios
  time frame: 3 hours
  description: The ability of PMI to detect different inspiratory effort contribution proportions was assessed using the Area Under the Receiver-Operating-Characteristics Curve (AUROC). The optimal cut-off values were selected based on the Youden index.
  measure: Tidal volume per predicted body weight (VT/PBW, ml/Kg)
  time frame: 3 hours
  description: We use the VT/PBW (ml/Kg) as lung-protective ventilation safety makers.
  measure: Respiratory rate (RR, circle/min)
  time frame: 3 hours
  description: We use the RR (circle/min) as lung-protective ventilation safety makers.
  measure: Transpulmonary driving pressure (DPlung, cmH2O)
  time frame: 3 hours
  description: We use the DPlung (cmH2O) as lung-protective ventilation safety makers.
  measure: Respiratory driving pressure (DPrs, cmH2O)
  time frame: 3 hours
  description: We use the DPrs (cmH2O) as lung-protective ventilation safety makers.
  measure: Respiratory muscle pressure (Pmus, cmH2O)
  time frame: 3 hours
  description: Our study chose Pmus (cmH2O) as the golden standard of inspiratory effort to estimate the validity of PMI-guided PS setting.
  measure: Esophageal pressure-time product (PTPes, cmH2O)
  time frame: 3 hours
  description: Our study chose PTPes (cmH2O) as the golden standard of inspiratory effort to estimate the validity of PMI-guided PS setting.
  arm group label: Experimental
  arm group type: Experimental
  description: PMI represents the difference between plateau airway pressure and peak airway pressure (plateau - peak) during an end-inspiratory airway occlusion.
  intervention type: Procedure
  intervention name: pressure support level tatrition
  description: Baseline ventilators were set by the principle of keeping VT/PBW at 6-8ml/kg and RR at 20-30 breaths/min and the decision of the responsible ICU physician. After then the fraction of inspired oxygen (FiO2), positive expiratory end pressure (PEEP), trigger sensitivity, and cycle-off criteria remain unchanged. Upward and downward PS level adjustments were performed from the baseline PS level at a 1cm H2O interval. Every PS level was maintained for 20 minutes and then three end-inspiratory holdings (2-3seconds) and three end-expiratory holdings were performed. PMI mean value was measured and calculated at every PS level. To avoid additional injury to the lung and diaphragm, the airway peak pressure (Ppeak) was limited to 30cmH2O, and titrating PS was stopped until PMI was less than -1cmH2O and more than 3cmH2O.The inspiratory effort is measured as the pressure generated by inspiratory muscles using esophageal pressure monitoring.
  arm group label: Experimental
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Jian-Xin Zhou, MD
  phone: 8610 63926888
  email: zhoujx.cn@icloud.com
  last name: Ran Gao, MD
  phone: +8617647611107
  email: 1205961482@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Capital Medical University
  investigator full name: Jian-Xin Zhou
  investigator title: Professor
  mesh term: Respiratory Aspiration
  sharing ipd: No