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/NCT05962125</url>
    </required_header>
    <id_info>
      <org_study_id>E2023069</org_study_id>
      <nct_id>NCT05962125</nct_id>
    </id_info>
    <brief_title>The Role of Periodic Alveolar Recruitment Maneuvers in Intraoperative Protective Ventilation</brief_title>
    <acronym>REMAIN-2</acronym>
    <official_title>Effects of Three Open-lung Strategies on Respiratory Function and Lung Injury in Protective Ventilation for Laparoscopic Anterior Resection: a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sixth Affiliated Hospital, Sun Yat-sen 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>
        The goal of this clinical trial is to compare three open-lung strategies on respiratory&#xD;
        function and lung injury in protective ventilation for laparoscopic anterior resection. It&#xD;
        aims to answer whether a periodic alveolar recruitment maneuvers (PARM) strategy alone was an&#xD;
        appropriate open-lung strategy in intraoperative protective ventilation. Patients were&#xD;
        randomly assigned (1:1:1) to receive one of three open-lung strategies in protective&#xD;
        ventilation: PARM alone (alveolar recruitment maneuvers [ARM] repeated every 30 min),&#xD;
        positive end-expiratory pressure (PEEP) alone (a PEEP of 6 to 8 cm H2O), or a combination of&#xD;
        PEEP and PARM (a PEEP of 6 to 8 cm H2O combined with ARM repeated every 30 min). The primary&#xD;
        outcome is the mechanical power before the end of intraoperative mechanical ventilation.&#xD;
        Secondary outcomes included the accumulative intraoperative mechanical power, an arterial&#xD;
        partial pressure of oxygen (PaO2) / inhaled oxygen concentration (FiO2) ratio (P/F ratio)&#xD;
        before the end of intraoperative mechanical ventilation, the rates of respiratory failure at&#xD;
        post-anesthesia care unit (PACU) and three postoperative days, the concentration of soluble&#xD;
        advanced glycation end products receptor (sRAGE) and Clara cell protein 16 (CC16) at the end&#xD;
        of surgery, postoperative pulmonary complications score, postoperative hospitalization days&#xD;
        and so on.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 21, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">November 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>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Intraoperative mechanical power</measure>
      <time_frame>Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery</time_frame>
      <description>Intraoperative mechanical power, calculated from values of tidal volume (Vt ), respiratory rate (RR), positive end-expiratory pressure (PEEP), plateau pressure (Pplat), and peak inspiratory pressure (Ppeak), using the following formula: mechanical power (J/min) = 0.098 × RR × Vt × (PEEP + ½[Pplat - PEEP] + [Ppeak - Pplat])</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mechanical power during capnoperitoneum</measure>
      <time_frame>30 minutes after starting carbon dioxide pneumoperitoneum</time_frame>
      <description>mechanical power, J/min</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Accumulative mechanical power (AMP)</measure>
      <time_frame>During intraoperative mechanical ventilation, an average of 3 hours</time_frame>
      <description>Accumulative mechanical power (AMP) = AMP before capnoperitoneum + AMP during capnoperitoneum + AMP after capnoperitoneum. Accumulative mechanical power before capnoperitoneum = mechanical power before capnoperitoneum (10 min after mechanical ventilation) × the length of mechanical ventilation before capnoperitoneum. Accumulative mechanical power during capnoperitoneum = mechanical power during capnoperitoneum (30 min after mechanical ventilation) × the length of mechanical ventilation during capnoperitoneum. Accumulative mechanical power after capnoperitoneum (after the end of capnoperitoneum) = mechanical power after capnoperitoneum (10 min after the end of capnoperitoneum) × the length of mechanical ventilation after capnoperitoneum</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>An arterial partial pressure of oxygen (PaO2) / Inhaled oxygen concentration (FIO2) ratio (P/F ratio)</measure>
      <time_frame>Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery</time_frame>
      <description>P/F ratio, mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Shunt fraction</measure>
      <time_frame>Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery</time_frame>
      <description>Shunt fraction, %</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dead space rate</measure>
      <time_frame>Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery</time_frame>
      <description>Arterial carbon dioxide partial pressure (PaCO2); partial pressure of carbon dioxide in end expiratory gas (PetCO2); Dead space fraction = (PaCO2-PetCO2)/ PaCO2.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of respiratory failure at post-anesthesia care unit (PACU)</measure>
      <time_frame>Stay in the PACU for at least 20 minutes and at most 3 hours; assessed at 5 to 10 minutes before leaving PACU</time_frame>
      <description>Respiratory failure: PaO2 &lt; 60 mmHg or pulse oxygen saturation (SpO2) &lt; 90% on room air, or a P/F ratio &lt; 300 mmHg and requiring oxygen therapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Soluble advanced glycation end products receptor (sRAGE)</measure>
      <time_frame>20 minutes after entering PACU</time_frame>
      <description>The concentration of plasma sRAGE, pg/ml</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clara cell protein 16 (CC16)</measure>
      <time_frame>20 minutes after entering PACU</time_frame>
      <description>The concentration of plasma CC16, ng/ml</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Surfactant Protein D (SP-D)</measure>
      <time_frame>20 minutes after entering PACU</time_frame>
      <description>The concentration of plasma SP-D, ug/ml</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interleukin 6 (IL-6)</measure>
      <time_frame>20 minutes after entering PACU</time_frame>
      <description>The concentration of plasma IL-6, pg/ml</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of postoperative respiratory failure</measure>
      <time_frame>Time Frame: Day 0 to 3 after surgery</time_frame>
      <description>Respiratory failure: PaO2 &lt; 60 mmHg or SpO2 &lt; 90% on room air, or a P/F ratio &lt; 300 mmHg and requiring oxygen therapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of sustained hypoxaemia</measure>
      <time_frame>Day 0 to 3 after surgery</time_frame>
      <description>Sustained hypoxaemia, hypoxaemia at any two consecutive days; hypoxaemia: during a follow-up visit when the patient was awake and breathing room air, SpO2 ≤ 92% or the change of SpO2 (ΔSpO2, preoperative SpO2 minus postoperative SpO2) ≥ 5%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative pulmonary complications score</measure>
      <time_frame>Day 0 to 3 after surgery</time_frame>
      <description>Postoperative pulmonary complications score: Operational Definitions of Postoperative Pulmonary Complications (Doi: 10.1001/jama.296.15.1851), graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative hospitalization days</measure>
      <time_frame>Day 0 to 30 after surgery</time_frame>
      <description>The duration between the operation date and the actual discharge date.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Death from any cause</measure>
      <time_frame>Day 0 to 30 after surgery</time_frame>
      <description>Intraoperative or postoperative death from any cause</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of intraoperative hypotension</measure>
      <time_frame>During intraoperative mechanical ventilation, an average of 3 hours</time_frame>
      <description>Intraoperative hypotension, mean arterial pressure (MAP) &lt; 60 mmHg lasting more than 3 minutes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of need for vasoconstrictors</measure>
      <time_frame>During intraoperative mechanical ventilation, an average of 3 hours</time_frame>
      <description>MAP &lt; 60 mmHg and using any vasoconstrictors.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of intraoperative hypoxemia</measure>
      <time_frame>During intraoperative mechanical ventilation, an average of 3 hours</time_frame>
      <description>Intraoperative hypoxemia, SpO2 ≤ 92% lasting more than 3 minutes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of intraoperative bradycardia</measure>
      <time_frame>During intraoperative mechanical ventilation, an average of 3 hours</time_frame>
      <description>Intraoperative bradycardia, heart rate ≤ 50 bpm and the decrease of heart rate from the basic value ≥ 20% lasting more than 3 minutes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of pneumothorax</measure>
      <time_frame>During surgery or within 7 days after surgery</time_frame>
      <description>Pneumothorax, air in the pleural space with no vascular bed surrounding the visceral pleura.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of pleural effusion</measure>
      <time_frame>within 7 days after surgery</time_frame>
      <description>Pleural effusion, diagnosed according to previous literature (Doi: 10.1097/EJA.0000000000000118).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Unexpected admission to ICU</measure>
      <time_frame>within 30 days after surgery</time_frame>
      <description>It does not include the patients who enter ICU at the request of surgeons but have normal spontaneous breathing, stable circulation and no disturbance of consciousness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tumor Necrosis Factor alpha (TNF-α)</measure>
      <time_frame>20 minutes after entering PACU</time_frame>
      <description>TNF-α, pg/ml.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Mechanical Power</condition>
    <condition>Alveolar Recruitment Maneuvers</condition>
    <condition>Protective Ventilation</condition>
    <condition>Postoperative Pulmonary Complications</condition>
    <arm_group>
      <arm_group_label>periodic alveolar recruitment maneuvers (PARM) alone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Alveolar recruitment maneuvers [ARM] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>positive end-expiratory pressure (PEEP) alone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set to 8 cm H2O.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>a combination of PEEP and PARM</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Alveolar recruitment maneuvers [ARM] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator. PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set at 8 cm H2O.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>periodic alveolar recruitment maneuvers</intervention_name>
      <description>A stepwise increment of tidal volume was used for each ARM.</description>
      <arm_group_label>a combination of PEEP and PARM</arm_group_label>
      <arm_group_label>periodic alveolar recruitment maneuvers (PARM) alone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>positive end-expiratory pressure</intervention_name>
      <description>a PEEP of 6 to 8 cm H2O</description>
      <arm_group_label>a combination of PEEP and PARM</arm_group_label>
      <arm_group_label>positive end-expiratory pressure (PEEP) alone</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Undergoing elective laparoscopic anterior resection and expected duration of&#xD;
               mechanical ventilation 2 to 5 h.&#xD;
  &#xD;
            2. Had an intermediate risk of developing postoperative pulmonary complications.&#xD;
  &#xD;
            3. Pulse oxygen saturation in room air ≥ 94%.&#xD;
  &#xD;
            4. Aged 60 to 80 years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Had received invasive mechanical ventilation for longer than 1 h within the last 2&#xD;
               weeks prior to surgery.&#xD;
  &#xD;
               2. Had a history of pneumonia within 1 month prior to surgery. 3. Had severe chronic&#xD;
               obstructive pulmonary disease or pulmonary bullae. 4. Had a progressive neuromuscular&#xD;
               illness. 5. With an American Society of Anesthesiologists (ASA) physical status of IV&#xD;
               or higher.&#xD;
  &#xD;
               6. Intracranial hypertension. 7. Body mass index (BMI) ≥30 kg/m2. 8. Were involved in&#xD;
               other interventional studies.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hong Li, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Sixth Affiliated Hospital, Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hong Li, MD</last_name>
      <phone>0086-020-38254070</phone>
      <email>lihong36@mail.sysu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nan-Rong Zhang, MD, PhD</last_name>
      <phone>02038254070</phone>
      <email>zhangnr3@mail.sysu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Sixth Affiliated Hospital, Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510655</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hong Li, Doctor</last_name>
        <phone>0086-020-38254070</phone>
        <email>lihong36@mail.sysu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT05962125
  org study id: E2023069
  nct id: NCT05962125
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare three open-lung strategies on respiratory
        function and lung injury in protective ventilation for laparoscopic anterior resection. It
        aims to answer whether a periodic alveolar recruitment maneuvers (PARM) strategy alone was an
        appropriate open-lung strategy in intraoperative protective ventilation. Patients were
        randomly assigned (1:1:1) to receive one of three open-lung strategies in protective
        ventilation: PARM alone (alveolar recruitment maneuvers [ARM] repeated every 30 min),
        positive end-expiratory pressure (PEEP) alone (a PEEP of 6 to 8 cm H2O), or a combination of
        PEEP and PARM (a PEEP of 6 to 8 cm H2O combined with ARM repeated every 30 min). The primary
        outcome is the mechanical power before the end of intraoperative mechanical ventilation.
        Secondary outcomes included the accumulative intraoperative mechanical power, an arterial
        partial pressure of oxygen (PaO2) / inhaled oxygen concentration (FiO2) ratio (P/F ratio)
        before the end of intraoperative mechanical ventilation, the rates of respiratory failure at
        post-anesthesia care unit (PACU) and three postoperative days, the concentration of soluble
        advanced glycation end products receptor (sRAGE) and Clara cell protein 16 (CC16) at the end
        of surgery, postoperative pulmonary complications score, postoperative hospitalization days
        and so on.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Intraoperative mechanical power
  time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
  description: Intraoperative mechanical power, calculated from values of tidal volume (Vt ), respiratory rate (RR), positive end-expiratory pressure (PEEP), plateau pressure (Pplat), and peak inspiratory pressure (Ppeak), using the following formula: mechanical power (J/min) = 0.098 × RR × Vt × (PEEP + ½[Pplat - PEEP] + [Ppeak - Pplat])
  measure: Mechanical power during capnoperitoneum
  time frame: 30 minutes after starting carbon dioxide pneumoperitoneum
  description: mechanical power, J/min
  measure: Accumulative mechanical power (AMP)
  time frame: During intraoperative mechanical ventilation, an average of 3 hours
  description: Accumulative mechanical power (AMP) = AMP before capnoperitoneum + AMP during capnoperitoneum + AMP after capnoperitoneum. Accumulative mechanical power before capnoperitoneum = mechanical power before capnoperitoneum (10 min after mechanical ventilation) × the length of mechanical ventilation before capnoperitoneum. Accumulative mechanical power during capnoperitoneum = mechanical power during capnoperitoneum (30 min after mechanical ventilation) × the length of mechanical ventilation during capnoperitoneum. Accumulative mechanical power after capnoperitoneum (after the end of capnoperitoneum) = mechanical power after capnoperitoneum (10 min after the end of capnoperitoneum) × the length of mechanical ventilation after capnoperitoneum
  measure: An arterial partial pressure of oxygen (PaO2) / Inhaled oxygen concentration (FIO2) ratio (P/F ratio)
  time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
  description: P/F ratio, mmHg
  measure: Shunt fraction
  time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
  description: Shunt fraction, %
  measure: Dead space rate
  time frame: Before the end of intraoperative mechanical ventilation, about 5 to 10 minutes before the end of surgery
  description: Arterial carbon dioxide partial pressure (PaCO2); partial pressure of carbon dioxide in end expiratory gas (PetCO2); Dead space fraction = (PaCO2-PetCO2)/ PaCO2.
  measure: Rate of respiratory failure at post-anesthesia care unit (PACU)
  time frame: Stay in the PACU for at least 20 minutes and at most 3 hours; assessed at 5 to 10 minutes before leaving PACU
  description: Respiratory failure: PaO2 < 60 mmHg or pulse oxygen saturation (SpO2) < 90% on room air, or a P/F ratio < 300 mmHg and requiring oxygen therapy.
  measure: Soluble advanced glycation end products receptor (sRAGE)
  time frame: 20 minutes after entering PACU
  description: The concentration of plasma sRAGE, pg/ml
  measure: Clara cell protein 16 (CC16)
  time frame: 20 minutes after entering PACU
  description: The concentration of plasma CC16, ng/ml
  measure: Surfactant Protein D (SP-D)
  time frame: 20 minutes after entering PACU
  description: The concentration of plasma SP-D, ug/ml
  measure: Interleukin 6 (IL-6)
  time frame: 20 minutes after entering PACU
  description: The concentration of plasma IL-6, pg/ml
  measure: Rate of postoperative respiratory failure
  time frame: Time Frame: Day 0 to 3 after surgery
  description: Respiratory failure: PaO2 < 60 mmHg or SpO2 < 90% on room air, or a P/F ratio < 300 mmHg and requiring oxygen therapy.
  measure: Rate of sustained hypoxaemia
  time frame: Day 0 to 3 after surgery
  description: Sustained hypoxaemia, hypoxaemia at any two consecutive days; hypoxaemia: during a follow-up visit when the patient was awake and breathing room air, SpO2 ≤ 92% or the change of SpO2 (ΔSpO2, preoperative SpO2 minus postoperative SpO2) ≥ 5%.
  measure: Postoperative pulmonary complications score
  time frame: Day 0 to 3 after surgery
  description: Postoperative pulmonary complications score: Operational Definitions of Postoperative Pulmonary Complications (Doi: 10.1001/jama.296.15.1851), graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications).
  measure: Postoperative hospitalization days
  time frame: Day 0 to 30 after surgery
  description: The duration between the operation date and the actual discharge date.
  measure: Death from any cause
  time frame: Day 0 to 30 after surgery
  description: Intraoperative or postoperative death from any cause
  measure: Rate of intraoperative hypotension
  time frame: During intraoperative mechanical ventilation, an average of 3 hours
  description: Intraoperative hypotension, mean arterial pressure (MAP) < 60 mmHg lasting more than 3 minutes.
  measure: Rate of need for vasoconstrictors
  time frame: During intraoperative mechanical ventilation, an average of 3 hours
  description: MAP < 60 mmHg and using any vasoconstrictors.
  measure: Rate of intraoperative hypoxemia
  time frame: During intraoperative mechanical ventilation, an average of 3 hours
  description: Intraoperative hypoxemia, SpO2 ≤ 92% lasting more than 3 minutes.
  measure: Rate of intraoperative bradycardia
  time frame: During intraoperative mechanical ventilation, an average of 3 hours
  description: Intraoperative bradycardia, heart rate ≤ 50 bpm and the decrease of heart rate from the basic value ≥ 20% lasting more than 3 minutes.
  measure: Rate of pneumothorax
  time frame: During surgery or within 7 days after surgery
  description: Pneumothorax, air in the pleural space with no vascular bed surrounding the visceral pleura.
  measure: Rate of pleural effusion
  time frame: within 7 days after surgery
  description: Pleural effusion, diagnosed according to previous literature (Doi: 10.1097/EJA.0000000000000118).
  measure: Unexpected admission to ICU
  time frame: within 30 days after surgery
  description: It does not include the patients who enter ICU at the request of surgeons but have normal spontaneous breathing, stable circulation and no disturbance of consciousness.
  measure: Tumor Necrosis Factor alpha (TNF-α)
  time frame: 20 minutes after entering PACU
  description: TNF-α, pg/ml.
  arm group label: periodic alveolar recruitment maneuvers (PARM) alone
  arm group type: Experimental
  description: Alveolar recruitment maneuvers [ARM] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator.
  arm group label: positive end-expiratory pressure (PEEP) alone
  arm group type: Active Comparator
  description: PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set to 8 cm H2O.
  arm group label: a combination of PEEP and PARM
  arm group type: Active Comparator
  description: Alveolar recruitment maneuvers [ARM] repeated every 30 min after tracheal intubation and after any disconnection from the ventilator. PEEP was routinely set at 6 cm H2O. If it was in a state of Trendelenburg position or carbon dioxide pneumoperitoneum, PEEP was set at 8 cm H2O.
  intervention type: Other
  intervention name: periodic alveolar recruitment maneuvers
  description: A stepwise increment of tidal volume was used for each ARM.
  arm group label: a combination of PEEP and PARM
  arm group label: periodic alveolar recruitment maneuvers (PARM) alone
  intervention type: Other
  intervention name: positive end-expiratory pressure
  description: a PEEP of 6 to 8 cm H2O
  arm group label: a combination of PEEP and PARM
  arm group label: positive end-expiratory pressure (PEEP) alone
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Hong Li, MD
  role: Principal Investigator
  affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
  last name: Hong Li, MD
  phone: 0086-020-38254070
  email: lihong36@mail.sysu.edu.cn
  last name: Nan-Rong Zhang, MD, PhD
  phone: 02038254070
  email: zhangnr3@mail.sysu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor