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/NCT06021249</url>
    </required_header>
    <id_info>
      <org_study_id>2021MZK04KY</org_study_id>
      <nct_id>NCT06021249</nct_id>
    </id_info>
    <brief_title>Comparing Innovative and Traditional Ventilation Strategies on Atelectasis and Prognosis in Elderly Patients</brief_title>
    <official_title>Comparing the Effects of Innovative and Traditional Lung-protective Ventilation Strategies on the Occurrence of Perioperative Atelectasis and Prognosis in Elderly Patients: a Prospective, Randomized, Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fujian Medical University Union Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The First Affiliated Hospital of Nanchang University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Hospital of Putian City, Putian, Fujian</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Fujian Medical University Union Hospital</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>
        This study was divided into two parts, taking elderly patients undergoing general anesthesia&#xD;
        surgery as the research subjects, through factorial design: 1. It was verified that in&#xD;
        elderly patients undergoing general anesthesia surgery, innovative lung-protective&#xD;
        ventilation strategies can reduce the occurrence of atelectasis and reduce the incidence of&#xD;
        ventilator-related lung injury and postoperative pulmonary complications more than&#xD;
        traditional lung-protective ventilation strategies; 2. On the basis of part one study proving&#xD;
        that innovative lung-protective ventilation strategies can reduce the incidence of&#xD;
        postoperative atelectasis and other complications in elderly patients undergoing general&#xD;
        anesthesia surgery compared with traditional lung-protective ventilation strategies, further&#xD;
        comparisons were made between the two factors of &quot;positive pressure extubation&quot; and &quot;improved&#xD;
        early postoperative respiratory training&quot; in the innovative lung protective ventilation&#xD;
        strategy, and whether there was an interaction between the two.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        More and more people need to undergo general anesthesia surgery at least once in the&#xD;
        lifetime, and patients who undergo general anesthesia surgery often have postoperative&#xD;
        pulmonary complications, and the occurrence of postoperative pulmonary complications is&#xD;
        related to the prolongation of the patient's hospital stay and postoperative mortality. This&#xD;
        is contrary to the current goal of rapid postoperative recovery.&#xD;
  &#xD;
        The International Expert Consensus on Strategies for Pulmonary Protective Ventilation states&#xD;
        that age &gt; 50 years is one of the greatest risk factors for postoperative pulmonary&#xD;
        complications. This means that even older patients with largely unimpaired preoperative lung&#xD;
        function are more likely to develop postoperative pulmonary complications than younger&#xD;
        patients. Therefore, the investigators set the study to elderly patients undergoing general&#xD;
        anesthesia surgery.&#xD;
  &#xD;
        The traditional lung-protective ventilation strategies commonly used to reduce atelectasis&#xD;
        and ventilator-related lung injury during general anesthesia surgery is controversial and&#xD;
        mixed. Based on literature review and preliminary experiments, this study focuses on&#xD;
        extubation and post-extubation, which is a critical period of atelectasis development,&#xD;
        combines positive pressure extubation technology with improved postoperative early breathing&#xD;
        training, replaces the controversial continuous positive airway pressure（CPAP）support and&#xD;
        alveolar recruitment manoeuvres in traditional lung protective ventilation strategies, and&#xD;
        explores a new respiratory management strategy with more operability and clinical effect to&#xD;
        reduce complications such as postoperative atelectasis in elderly patients.&#xD;
  &#xD;
        This study was originally a single-center clinical study and has been registered in the&#xD;
        Chinese Clinical Trial Registry（Registration number：ChiCTR2300071364）. It was later changed&#xD;
        to a multi-center clinical study, so it was re-registered.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 28, 2021</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">December 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>Factorial Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Volume ratio of new-onset atelectasis after surgery</measure>
      <time_frame>Pre-surgery;Approximately 24 hours after surgery</time_frame>
      <description>After lung CT examination, the postoperative volume ratio of new atelectasis (new atelectasis volume/total lung volume) was calculated.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>postoperative pulmonary complications</measure>
      <time_frame>Within 14 days after surgery; Within 30 days after surgery</time_frame>
      <description>Diagnosis according to the US Centers for Disease Control definition of pneumonia:&#xD;
  Two or more serial chest radiographs with at least one of the following (one radiograph is sufficient for patients with no underlying pulmonary or cardiac disease):&#xD;
  (i) New or progressive and persistent infiltrates, (ii)consolidation, (iii) cavitation;&#xD;
  AND at least one of the following:&#xD;
  fever (&gt;38°C) with no other recognised cause,&#xD;
  leucopaenia (white cell count &lt;4*10^9/ litre) or leucocytosis(white cell count &gt;12*10^9 /litre),&#xD;
  for adults &gt;70 years old, altered mental status with no other recognised cause;&#xD;
  AND at least two of the following:&#xD;
  new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements,&#xD;
  new onset or worsening cough, or dyspnoea, or tachypnoea,&#xD;
  rales or bronchial breath sounds,&#xD;
  worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>specific indexes of ventilator-related lung injury</measure>
      <time_frame>Pre-surgery;Immediately after the extubation;Approximately 24 hours after surgery</time_frame>
      <description>Blood was drawn and centrifuged for serum ELISA to detect landmark indicators of ventilator-related lung injury</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>oxygenation index</measure>
      <time_frame>Pre-surgery;20 minutes after the intubation;End of the operation;Approximately 10 minutes after the extubation;Approximately 40 minutes after the extubation;Approximately 70 minutes after the extubation;Approximately 24 hours after surgery</time_frame>
      <description>Arterial blood samples are drawn for blood gas analysis</description>
    </secondary_outcome>
    <number_of_arms>8</number_of_arms>
    <enrollment type="Anticipated">304</enrollment>
    <condition>Ventilator-associated Lung Injury</condition>
    <condition>Atelectasis</condition>
    <condition>Postoperative Pulmonary Complications</condition>
    <arm_group>
      <arm_group_label>Group of Control (Part I experiment)</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Traditional ventilation strategies</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group of traditional lung-protective ventilation (Part I experiment)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Traditional lung-protective ventilation strategies</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group of innovative lung-protective ventilation (Part I experiment)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Innovative lung-protective ventilation strategies</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group of traditional &amp; innovative ventilation (Part I experiment)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Traditional &amp; innovative lung protection ventilation strategies</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group of Control (Part II experiment)</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>lung-protective ventilation；&#xD;
  negative pressure extubation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group of positive pressure extubation (Part II experiment)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>lung-protective ventilation；&#xD;
  positive pressure extubation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group of breathing training (Part II experiment)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>lung-protective ventilation；&#xD;
  negative pressure extubation；&#xD;
  postoperative breathing training</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group of positive pressure extubation &amp; breathing training (Part II experiment)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>lung-protective ventilation；&#xD;
  positive pressure extubation；&#xD;
  postoperative breathing training</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Traditional ventilation strategies</intervention_name>
      <description>Tidal volume：10ml/kg predicted body weight（PBW）；&#xD;
  0 cm H2O positive end expiratory pressure（PEEP）；&#xD;
  negative pressure extubation</description>
      <arm_group_label>Group of Control (Part I experiment)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Traditional lung-protective ventilation strategies</intervention_name>
      <description>Tidal volume：6ml/kg PBW；&#xD;
  5cmH2O PEEP；&#xD;
  Ventilator-controlled recruitment manoeuvre；&#xD;
  CPAP；&#xD;
  negative pressure extubation</description>
      <arm_group_label>Group of traditional &amp; innovative ventilation (Part I experiment)</arm_group_label>
      <arm_group_label>Group of traditional lung-protective ventilation (Part I experiment)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Innovative lung-protective ventilation strategies</intervention_name>
      <description>Tidal volume：6ml/kg PBW；&#xD;
  5cmH2O PEEP；&#xD;
  positive pressure extubation；&#xD;
  postoperative breathing training</description>
      <arm_group_label>Group of innovative lung-protective ventilation (Part I experiment)</arm_group_label>
      <arm_group_label>Group of traditional &amp; innovative ventilation (Part I experiment)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Lung-protective ventilation</intervention_name>
      <description>Tidal volume：6ml/kg PBW；&#xD;
  5cmH2O PEEP；</description>
      <arm_group_label>Group of Control (Part II experiment)</arm_group_label>
      <arm_group_label>Group of breathing training (Part II experiment)</arm_group_label>
      <arm_group_label>Group of positive pressure extubation &amp; breathing training (Part II experiment)</arm_group_label>
      <arm_group_label>Group of positive pressure extubation (Part II experiment)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>negative pressure extubation</intervention_name>
      <description>The suction tube is inserted into the endotracheal tube, continuous negative pressure suction, and at the same time that the balloon is completely deflated, the suction tube, dental pad and endotracheal intubation are pulled out at the same time, and then the patient is instructed to cough independently and remove sputum.</description>
      <arm_group_label>Group of Control (Part II experiment)</arm_group_label>
      <arm_group_label>Group of breathing training (Part II experiment)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>positive pressure extubation</intervention_name>
      <description>The adjustable pressure limiting（APL）was adjusted to 30cm H2O, and after the patient breathed spontaneously until the peak airway pressure reached 30cm H2O, and after maintaining this level for 10s, the balloon was quickly cut off to remove the endotracheal tube, so that the patient had an autonomous coughing action, and then the oral sputum was removed.</description>
      <arm_group_label>Group of positive pressure extubation &amp; breathing training (Part II experiment)</arm_group_label>
      <arm_group_label>Group of positive pressure extubation (Part II experiment)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>postoperative breathing training</intervention_name>
      <description>Inhale deeply through the nose, hold the breath for 5s, and then slowly spit out the breath through the mouth, cycle 5-6 times, and inflate the balloon. The above steps need to be performed 15 times within 24 hours after surgery.</description>
      <arm_group_label>Group of breathing training (Part II experiment)</arm_group_label>
      <arm_group_label>Group of positive pressure extubation &amp; breathing training (Part II experiment)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Elderly patients aged ≥ 60 years old who undergo laparoscopic abdominal surgery；&#xD;
  &#xD;
            2. Body mass index（BMI） &lt;30；&#xD;
  &#xD;
            3. American society of anesthesiologists physical status classification&#xD;
               system（ASA）:I-III；&#xD;
  &#xD;
            4. When the patient inhales air before surgery, SPO2≥94%；&#xD;
  &#xD;
            5. The duration of the operation is 2-7 hours, and the pneumoperitoneal pressure is&#xD;
               10-14mmHg.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with acute respiratory distress syndrome or pulmonary hypertension (pulmonary&#xD;
               systolic blood pressure ≥ 40mmHg) or bronchiectasis or lung malignant tumors&#xD;
  &#xD;
            2. Patients with acute respiratory infections within one month before surgery&#xD;
  &#xD;
            3. Patients who have undergone cardiopulmonary surgery&#xD;
  &#xD;
            4. Receiving invasive mechanical ventilation for more than 30min within 30 days before&#xD;
               surgery&#xD;
  &#xD;
            5. Patients with peak airway pressure &gt; 35 cm H2O during intraoperative mechanical&#xD;
               ventilation&#xD;
  &#xD;
            6. Patients with severe organic lesions of the heart such as obvious heart failure and&#xD;
               coronary heart disease&#xD;
  &#xD;
            7. Patients with preoperative anemia (Hb&lt;10g/L)&#xD;
  &#xD;
            8. Patients with hypoproteinemia before surgery (albumin &lt; 35 g/L)&#xD;
  &#xD;
            9. Patients with tracheostomy and severe difficult airway&#xD;
  &#xD;
           10. Patients with sleep apnea syndrome&#xD;
  &#xD;
           11. Patients with intraoperative heavy bleeding (50% of the circulating blood volume is&#xD;
               lost ≥ 3 hours)&#xD;
  &#xD;
           12. Patients with mental illness, impaired consciousness and communication disorders&#xD;
  &#xD;
           13. Patients who refuse to participate in this trial&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zhongmeng Lai</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fujian Medical University Union Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lingli Pan</last_name>
      <phone>+86 18065184976</phone>
      <email>panlin199104@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhongmeng Lai</last_name>
      <phone>+86 13395000771</phone>
      <email>angerer1980@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fujian Medical University Union Hospital</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lingli Pan</last_name>
        <phone>+86 18065184976</phone>
        <email>panlin199104@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Putian</name>
        <address>
          <city>Putian</city>
          <state>Fujian</state>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Huan Chen</last_name>
        <phone>+86 15080007150</phone>
        <email>flyupinsky@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Nanchang University</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jia Min</last_name>
        <phone>+86 13970899291</phone>
        <email>candymin66@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>perioperative strategies for lung-protective ventilation</keyword>
    <keyword>elderly patients</keyword>
    <keyword>atelectasis</keyword>
    <keyword>postoperative pulmonary complications</keyword>
    <keyword>lung injury</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Injury</mesh_term>
      <mesh_term>Pulmonary Atelectasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>In June 2024, raw data was shared through ResMan（http://www.medresman.org.cn/login.aspx）</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>In June 2024, raw data was shared for 6 months.</ipd_time_frame>
      <ipd_access_criteria>Accessible to any researcher</ipd_access_criteria>
      <ipd_url>http://www.medresman.org.cn/login.aspx</ipd_url>
    </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/NCT06021249
  org study id: 2021MZK04KY
  nct id: NCT06021249
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study was divided into two parts, taking elderly patients undergoing general anesthesia
        surgery as the research subjects, through factorial design: 1. It was verified that in
        elderly patients undergoing general anesthesia surgery, innovative lung-protective
        ventilation strategies can reduce the occurrence of atelectasis and reduce the incidence of
        ventilator-related lung injury and postoperative pulmonary complications more than
        traditional lung-protective ventilation strategies; 2. On the basis of part one study proving
        that innovative lung-protective ventilation strategies can reduce the incidence of
        postoperative atelectasis and other complications in elderly patients undergoing general
        anesthesia surgery compared with traditional lung-protective ventilation strategies, further
        comparisons were made between the two factors of "positive pressure extubation" and "improved
        early postoperative respiratory training" in the innovative lung protective ventilation
        strategy, and whether there was an interaction between the two.
  More and more people need to undergo general anesthesia surgery at least once in the
        lifetime, and patients who undergo general anesthesia surgery often have postoperative
        pulmonary complications, and the occurrence of postoperative pulmonary complications is
        related to the prolongation of the patient's hospital stay and postoperative mortality. This
        is contrary to the current goal of rapid postoperative recovery.
  
        The International Expert Consensus on Strategies for Pulmonary Protective Ventilation states
        that age > 50 years is one of the greatest risk factors for postoperative pulmonary
        complications. This means that even older patients with largely unimpaired preoperative lung
        function are more likely to develop postoperative pulmonary complications than younger
        patients. Therefore, the investigators set the study to elderly patients undergoing general
        anesthesia surgery.
  
        The traditional lung-protective ventilation strategies commonly used to reduce atelectasis
        and ventilator-related lung injury during general anesthesia surgery is controversial and
        mixed. Based on literature review and preliminary experiments, this study focuses on
        extubation and post-extubation, which is a critical period of atelectasis development,
        combines positive pressure extubation technology with improved postoperative early breathing
        training, replaces the controversial continuous positive airway pressure（CPAP）support and
        alveolar recruitment manoeuvres in traditional lung protective ventilation strategies, and
        explores a new respiratory management strategy with more operability and clinical effect to
        reduce complications such as postoperative atelectasis in elderly patients.
  
        This study was originally a single-center clinical study and has been registered in the
        Chinese Clinical Trial Registry（Registration number：ChiCTR2300071364）. It was later changed
        to a multi-center clinical study, so it was re-registered.
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Volume ratio of new-onset atelectasis after surgery
  time frame: Pre-surgery;Approximately 24 hours after surgery
  description: After lung CT examination, the postoperative volume ratio of new atelectasis (new atelectasis volume/total lung volume) was calculated.
  measure: postoperative pulmonary complications
  time frame: Within 14 days after surgery; Within 30 days after surgery
  description: Diagnosis according to the US Centers for Disease Control definition of pneumonia:
  Two or more serial chest radiographs with at least one of the following (one radiograph is sufficient for patients with no underlying pulmonary or cardiac disease):
  (i) New or progressive and persistent infiltrates, (ii)consolidation, (iii) cavitation;
  AND at least one of the following:
  fever (>38°C) with no other recognised cause,
  leucopaenia (white cell count <4*10^9/ litre) or leucocytosis(white cell count >12*10^9 /litre),
  for adults >70 years old, altered mental status with no other recognised cause;
  AND at least two of the following:
  new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements,
  new onset or worsening cough, or dyspnoea, or tachypnoea,
  rales or bronchial breath sounds,
  worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).
  measure: specific indexes of ventilator-related lung injury
  time frame: Pre-surgery;Immediately after the extubation;Approximately 24 hours after surgery
  description: Blood was drawn and centrifuged for serum ELISA to detect landmark indicators of ventilator-related lung injury
  measure: oxygenation index
  time frame: Pre-surgery;20 minutes after the intubation;End of the operation;Approximately 10 minutes after the extubation;Approximately 40 minutes after the extubation;Approximately 70 minutes after the extubation;Approximately 24 hours after surgery
  description: Arterial blood samples are drawn for blood gas analysis
  arm group label: Group of Control (Part I experiment)
  arm group type: Sham Comparator
  description: Traditional ventilation strategies
  arm group label: Group of traditional lung-protective ventilation (Part I experiment)
  arm group type: Experimental
  description: Traditional lung-protective ventilation strategies
  arm group label: Group of innovative lung-protective ventilation (Part I experiment)
  arm group type: Experimental
  description: Innovative lung-protective ventilation strategies
  arm group label: Group of traditional & innovative ventilation (Part I experiment)
  arm group type: Experimental
  description: Traditional & innovative lung protection ventilation strategies
  arm group label: Group of Control (Part II experiment)
  arm group type: Sham Comparator
  description: lung-protective ventilation；
  negative pressure extubation
  arm group label: Group of positive pressure extubation (Part II experiment)
  arm group type: Experimental
  description: lung-protective ventilation；
  positive pressure extubation
  arm group label: Group of breathing training (Part II experiment)
  arm group type: Experimental
  description: lung-protective ventilation；
  negative pressure extubation；
  postoperative breathing training
  arm group label: Group of positive pressure extubation & breathing training (Part II experiment)
  arm group type: Experimental
  description: lung-protective ventilation；
  positive pressure extubation；
  postoperative breathing training
  intervention type: Procedure
  intervention name: Traditional ventilation strategies
  description: Tidal volume：10ml/kg predicted body weight（PBW）；
  0 cm H2O positive end expiratory pressure（PEEP）；
  negative pressure extubation
  arm group label: Group of Control (Part I experiment)
  intervention type: Procedure
  intervention name: Traditional lung-protective ventilation strategies
  description: Tidal volume：6ml/kg PBW；
  5cmH2O PEEP；
  Ventilator-controlled recruitment manoeuvre；
  CPAP；
  negative pressure extubation
  arm group label: Group of traditional & innovative ventilation (Part I experiment)
  arm group label: Group of traditional lung-protective ventilation (Part I experiment)
  intervention type: Procedure
  intervention name: Innovative lung-protective ventilation strategies
  description: Tidal volume：6ml/kg PBW；
  5cmH2O PEEP；
  positive pressure extubation；
  postoperative breathing training
  arm group label: Group of innovative lung-protective ventilation (Part I experiment)
  arm group label: Group of traditional & innovative ventilation (Part I experiment)
  intervention type: Procedure
  intervention name: Lung-protective ventilation
  description: Tidal volume：6ml/kg PBW；
  5cmH2O PEEP；
  arm group label: Group of Control (Part II experiment)
  arm group label: Group of breathing training (Part II experiment)
  arm group label: Group of positive pressure extubation & breathing training (Part II experiment)
  arm group label: Group of positive pressure extubation (Part II experiment)
  intervention type: Procedure
  intervention name: negative pressure extubation
  description: The suction tube is inserted into the endotracheal tube, continuous negative pressure suction, and at the same time that the balloon is completely deflated, the suction tube, dental pad and endotracheal intubation are pulled out at the same time, and then the patient is instructed to cough independently and remove sputum.
  arm group label: Group of Control (Part II experiment)
  arm group label: Group of breathing training (Part II experiment)
  intervention type: Procedure
  intervention name: positive pressure extubation
  description: The adjustable pressure limiting（APL）was adjusted to 30cm H2O, and after the patient breathed spontaneously until the peak airway pressure reached 30cm H2O, and after maintaining this level for 10s, the balloon was quickly cut off to remove the endotracheal tube, so that the patient had an autonomous coughing action, and then the oral sputum was removed.
  arm group label: Group of positive pressure extubation & breathing training (Part II experiment)
  arm group label: Group of positive pressure extubation (Part II experiment)
  intervention type: Procedure
  intervention name: postoperative breathing training
  description: Inhale deeply through the nose, hold the breath for 5s, and then slowly spit out the breath through the mouth, cycle 5-6 times, and inflate the balloon. The above steps need to be performed 15 times within 24 hours after surgery.
  arm group label: Group of breathing training (Part II experiment)
  arm group label: Group of positive pressure extubation & breathing training (Part II experiment)
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Zhongmeng Lai
  role: Principal Investigator
  affiliation: Fujian Medical University Union Hospital
  last name: Lingli Pan
  phone: +86 18065184976
  email: panlin199104@163.com
  last name: Zhongmeng Lai
  phone: +86 13395000771
  email: angerer1980@163.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Lung Injury
  mesh term: Pulmonary Atelectasis
  sharing ipd: Yes
  ipd description: In June 2024, raw data was shared through ResMan（http://www.medresman.org.cn/login.aspx）
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: In June 2024, raw data was shared for 6 months.
  ipd access criteria: Accessible to any researcher
  ipd url: http://www.medresman.org.cn/login.aspx