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/NCT06023017</url>
    </required_header>
    <id_info>
      <org_study_id>CQMUAZD2023-2</org_study_id>
      <nct_id>NCT06023017</nct_id>
    </id_info>
    <brief_title>The Effect of Preoperative Prone Position Training on PPCs in Patients Undergoing Laparoscopic Sleeve Gastrectomy</brief_title>
    <official_title>The Effect of Preoperative Prone Position Training on Postoperative Pulmonary Complications in Patients Undergoing Laparoscopic Sleeve Gastrectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Min Su</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital of Chongqing Medical University</source>
    <oversight_info>
      <has_dmc>No</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>
        Postoperative pulmonary complications(PPCs) is a common complication in patients undergoing&#xD;
        surgery under general anesthesia, particularly in obese patients. Relevant studies have shown&#xD;
        that PPCs are more common in patients undergoing laparoscopic sleeve gastrectomy, which&#xD;
        contribute to significant increases in morbidity, mortality, length of postoperative hospital&#xD;
        stay and medical consumption. According to some reports, the incidence of PPCs in obese&#xD;
        patients after abdominal surgery is about 40%. The reduction in pulmonary volume and&#xD;
        respiratory muscular activation after major abdominal surgery due to surgery-related shallow&#xD;
        breathing, pain, longterm bed rest, mucociliary clearance disorder, and diaphragmatic&#xD;
        dysfunction may be the main causes of PPCs.&#xD;
  &#xD;
        Numerous studies have demonstrated physiological improvement related to prone positioning.&#xD;
        Prone positioning consists of placing a patient face down. Prone positioning has been used&#xD;
        for to improve oxygenation in patients who require invasive mechanical ventilation for acute&#xD;
        respiratory distress syndrome (ARDS). It has also been applied to non-intubated patients with&#xD;
        acute respiratory failure (ARF), to improve oxygenation and delay or even avoid the need for&#xD;
        invasive ventilation. So, the purpose of this study is to observe whether preoperative prone&#xD;
        position training can reduce the incidence of pulmonary complications after laparoscopic&#xD;
        sleeve gastrectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Postoperative pulmonary complications(PPCs) is a common complication in patients undergoing&#xD;
        surgery under general anesthesia, particularly in obese patients. PPCs refer to the clinical&#xD;
        abnormal changes in the lungs after surgery, These include lung infections (pneumonia),&#xD;
        atelectasis, pleural effusion, bronchospasm, acute respiratory failure or acute respiratory&#xD;
        distress syndrome (ARDS). Postoperative atelectasis could last for more than 24h and&#xD;
        contribute to a variety of other complications, including hypoxemia and pneumonia. Relevant&#xD;
        studies have shown that PPCs are more common in patients undergoing laparoscopic sleeve&#xD;
        gastrectomy, which contribute to significant increases in morbidity, mortality, length of&#xD;
        postoperative hospital stay and medical consumption. According to some reports, the incidence&#xD;
        of PPCs in obese patients after abdominal surgery is about 40%，and our hospital preliminary&#xD;
        investigation, the incidence of PPCs in patients undergoing laparoscopic sleeve gastrectomy&#xD;
        is approximately 30%. The reduction in pulmonary volume and respiratory muscular activation&#xD;
        after major abdominal surgery due to surgery-related shallow breathing, pain, longterm bed&#xD;
        rest, mucociliary clearance disorder, and diaphragmatic dysfunction may be the main causes of&#xD;
        PPCs.&#xD;
  &#xD;
        Numerous studies have demonstrated physiological improvement related to prone positioning.&#xD;
        Prone positioning consists of placing a patient face down. Prone positioning has been used&#xD;
        for to improve oxygenation in patients who require invasive mechanical ventilation for acute&#xD;
        respiratory distress syndrome (ARDS). It has also been applied to non-intubated patients with&#xD;
        acute respiratory failure (ARF), to improve oxygenation and delay or even avoid the need for&#xD;
        invasive ventilation.&#xD;
  &#xD;
        Currently, the mechanisms of prone position training are decreased lung compression in the&#xD;
        gravity dependant zone,homogenisation of transpulmonary pressure, improvement of&#xD;
        ventilation/perfusion ratio, and reduction of ventilator-induced lung injury (VILI) or&#xD;
        patient self-inflicted lung injury (P-SILI). By placing the patient in the prone position,&#xD;
        the lungs compression due to its own weight is reduced via a gravitational-dependent&#xD;
        redistribution of fluids. In addition,the weight of the mediastinum is supported by the&#xD;
        sternum, the stiffer part of the chest. At the same time, the diaphragm is displaced&#xD;
        caudally, decreasing compression of the posterior-caudal lung parenchyma. Finally, in a&#xD;
        triangular-shaped lung, more parenchyma is included in the dorsal half than in the ventral&#xD;
        one resulting in a more aerated lung in prone positioning.&#xD;
  &#xD;
        So, the purpose of this study is to observe whether preoperative prone position training can&#xD;
        reduce the incidence of PPCs after laparoscopic sleeve gastrectomy.&#xD;
  &#xD;
        This study was approved by the institutional review board of the First Affiliated Hospital of&#xD;
        Chongqing Medical University. The protocol design is in accordance with Consolidated&#xD;
        Standards of Reporting Trials (CONSORT) statement. All potentially eligible participants will&#xD;
        be asked to give written informed consent before they are enrolled in this study. This study&#xD;
        is a prospective, randomized, controlled clinical trial guided by the standard of good&#xD;
        clinical practice (GCP),and eligible participants are divided into two groups: group PPT and&#xD;
        group C,and primary assess the incidence of PPCs after laparoscopic sleeve gastrectomy&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The incidence of postoperative pulmonary complications(PPCs)</measure>
      <time_frame>3 days after surgery</time_frame>
      <description>The PPCs included pneumonia, atelectasis, pleural effusion, respiratory failure, and unplanned intubations</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>arterial partial pressure of oxygen (PaO2)</measure>
      <time_frame>preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery</time_frame>
      <description>Based on the blood gas analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>arterial partial pressure of carbon dioxide (PaCO2)</measure>
      <time_frame>preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery</time_frame>
      <description>Based on the blood gas analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>oxygenation index (OI)</measure>
      <time_frame>preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery</time_frame>
      <description>Based on the blood gas analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>extubation time</measure>
      <time_frame>1 Day of surgery</time_frame>
      <description>extubation time in postanesthesia care unit(PACU)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">78</enrollment>
    <condition>Postoperative Pulmonary Complications</condition>
    <arm_group>
      <arm_group_label>Prone Position Training group (PPT group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All patients were admitted to our hospital at least 3 days before surgery. Patients in the intervention group (PPT group) received the prone position training daily in the hospital, three times a day, and about 1 hours every times, for at least 3 days before surgery. On the day of admission to the hospital, the patients in the PPT group were instructed to perform prone position training by nurses who were previously trained by prone position training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group (C group)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients in the control group (C group) received standard perioperative care without any prone position training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Prone Position Training</intervention_name>
      <description>All patients were admitted to our hospital at least 3 days before surgery. Patients in the intervention group (PPT group) received the prone position training daily in the hospital, three times a day, and about 1 hours every times, for at least 3 days before surgery. On the day of admission to the hospital, the patients in the PPT group were instructed to perform prone position training by nurses who were previously trained by prone position training.</description>
      <arm_group_label>Prone Position Training group (PPT group)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>standard perioperative care without any prone position training</intervention_name>
      <description>Patients in the control group (C group) received standard perioperative care without any prone position training.</description>
      <arm_group_label>Control group (C group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age over 18 years old&#xD;
  &#xD;
            -  Body mass index(BMI)≥30 kg/m2&#xD;
  &#xD;
            -  Clinical diagnosis of metabolic syndrome, and undergoing Laparoscopic Sleeve&#xD;
               Gastrectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Emergency surgery&#xD;
  &#xD;
            -  Cognitive dysfunction&#xD;
  &#xD;
            -  American Society of Anesthesiologists class ≥ IV&#xD;
  &#xD;
            -  Fractures (face, collarbone, ribs, spine, limbs)&#xD;
  &#xD;
            -  History of spontaneous pneumothorax&#xD;
  &#xD;
            -  Increased intracranial pressure&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  Systemic infection&#xD;
  &#xD;
            -  Patients with hemodynamic instability&#xD;
  &#xD;
            -  Other conditions that are not suitable for prone position&#xD;
  &#xD;
            -  Failure to obtain informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Su Min, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>First Affiliated Hospital of Chongqing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dong Zhang, Master</last_name>
      <phone>+86-023-89011069</phone>
      <email>848138113@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Chongqing Medical University</name>
        <address>
          <city>Chongqing</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Dong Zhang, Master</last_name>
        <phone>+86-023-89011069</phone>
        <email>848138113@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>First Affiliated Hospital of Chongqing Medical University</investigator_affiliation>
      <investigator_full_name>Min Su</investigator_full_name>
      <investigator_title>Professor of Anesthesiology</investigator_title>
    </responsible_party>
    <keyword>pulmonary complications, prone position,sleeve gastrectomy</keyword>
    <!-- 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/NCT06023017
  org study id: CQMUAZD2023-2
  nct id: NCT06023017
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Postoperative pulmonary complications(PPCs) is a common complication in patients undergoing
        surgery under general anesthesia, particularly in obese patients. Relevant studies have shown
        that PPCs are more common in patients undergoing laparoscopic sleeve gastrectomy, which
        contribute to significant increases in morbidity, mortality, length of postoperative hospital
        stay and medical consumption. According to some reports, the incidence of PPCs in obese
        patients after abdominal surgery is about 40%. The reduction in pulmonary volume and
        respiratory muscular activation after major abdominal surgery due to surgery-related shallow
        breathing, pain, longterm bed rest, mucociliary clearance disorder, and diaphragmatic
        dysfunction may be the main causes of PPCs.
  
        Numerous studies have demonstrated physiological improvement related to prone positioning.
        Prone positioning consists of placing a patient face down. Prone positioning has been used
        for to improve oxygenation in patients who require invasive mechanical ventilation for acute
        respiratory distress syndrome (ARDS). It has also been applied to non-intubated patients with
        acute respiratory failure (ARF), to improve oxygenation and delay or even avoid the need for
        invasive ventilation. So, the purpose of this study is to observe whether preoperative prone
        position training can reduce the incidence of pulmonary complications after laparoscopic
        sleeve gastrectomy.
  Postoperative pulmonary complications(PPCs) is a common complication in patients undergoing
        surgery under general anesthesia, particularly in obese patients. PPCs refer to the clinical
        abnormal changes in the lungs after surgery, These include lung infections (pneumonia),
        atelectasis, pleural effusion, bronchospasm, acute respiratory failure or acute respiratory
        distress syndrome (ARDS). Postoperative atelectasis could last for more than 24h and
        contribute to a variety of other complications, including hypoxemia and pneumonia. Relevant
        studies have shown that PPCs are more common in patients undergoing laparoscopic sleeve
        gastrectomy, which contribute to significant increases in morbidity, mortality, length of
        postoperative hospital stay and medical consumption. According to some reports, the incidence
        of PPCs in obese patients after abdominal surgery is about 40%，and our hospital preliminary
        investigation, the incidence of PPCs in patients undergoing laparoscopic sleeve gastrectomy
        is approximately 30%. The reduction in pulmonary volume and respiratory muscular activation
        after major abdominal surgery due to surgery-related shallow breathing, pain, longterm bed
        rest, mucociliary clearance disorder, and diaphragmatic dysfunction may be the main causes of
        PPCs.
  
        Numerous studies have demonstrated physiological improvement related to prone positioning.
        Prone positioning consists of placing a patient face down. Prone positioning has been used
        for to improve oxygenation in patients who require invasive mechanical ventilation for acute
        respiratory distress syndrome (ARDS). It has also been applied to non-intubated patients with
        acute respiratory failure (ARF), to improve oxygenation and delay or even avoid the need for
        invasive ventilation.
  
        Currently, the mechanisms of prone position training are decreased lung compression in the
        gravity dependant zone,homogenisation of transpulmonary pressure, improvement of
        ventilation/perfusion ratio, and reduction of ventilator-induced lung injury (VILI) or
        patient self-inflicted lung injury (P-SILI). By placing the patient in the prone position,
        the lungs compression due to its own weight is reduced via a gravitational-dependent
        redistribution of fluids. In addition,the weight of the mediastinum is supported by the
        sternum, the stiffer part of the chest. At the same time, the diaphragm is displaced
        caudally, decreasing compression of the posterior-caudal lung parenchyma. Finally, in a
        triangular-shaped lung, more parenchyma is included in the dorsal half than in the ventral
        one resulting in a more aerated lung in prone positioning.
  
        So, the purpose of this study is to observe whether preoperative prone position training can
        reduce the incidence of PPCs after laparoscopic sleeve gastrectomy.
  
        This study was approved by the institutional review board of the First Affiliated Hospital of
        Chongqing Medical University. The protocol design is in accordance with Consolidated
        Standards of Reporting Trials (CONSORT) statement. All potentially eligible participants will
        be asked to give written informed consent before they are enrolled in this study. This study
        is a prospective, randomized, controlled clinical trial guided by the standard of good
        clinical practice (GCP),and eligible participants are divided into two groups: group PPT and
        group C,and primary assess the incidence of PPCs after laparoscopic sleeve gastrectomy
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Investigator)
  measure: The incidence of postoperative pulmonary complications(PPCs)
  time frame: 3 days after surgery
  description: The PPCs included pneumonia, atelectasis, pleural effusion, respiratory failure, and unplanned intubations
  measure: arterial partial pressure of oxygen (PaO2)
  time frame: preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery
  description: Based on the blood gas analysis
  measure: arterial partial pressure of carbon dioxide (PaCO2)
  time frame: preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery
  description: Based on the blood gas analysis
  measure: oxygenation index (OI)
  time frame: preoperatively prior to starting prone position training, entering the operating room, the first day after surgery, the second day after surgery, and the third day after surgery
  description: Based on the blood gas analysis
  measure: extubation time
  time frame: 1 Day of surgery
  description: extubation time in postanesthesia care unit(PACU)
  arm group label: Prone Position Training group (PPT group)
  arm group type: Experimental
  description: All patients were admitted to our hospital at least 3 days before surgery. Patients in the intervention group (PPT group) received the prone position training daily in the hospital, three times a day, and about 1 hours every times, for at least 3 days before surgery. On the day of admission to the hospital, the patients in the PPT group were instructed to perform prone position training by nurses who were previously trained by prone position training.
  arm group label: Control group (C group)
  arm group type: Placebo Comparator
  description: Patients in the control group (C group) received standard perioperative care without any prone position training.
  intervention type: Behavioral
  intervention name: Prone Position Training
  description: All patients were admitted to our hospital at least 3 days before surgery. Patients in the intervention group (PPT group) received the prone position training daily in the hospital, three times a day, and about 1 hours every times, for at least 3 days before surgery. On the day of admission to the hospital, the patients in the PPT group were instructed to perform prone position training by nurses who were previously trained by prone position training.
  arm group label: Prone Position Training group (PPT group)
  intervention type: Behavioral
  intervention name: standard perioperative care without any prone position training
  description: Patients in the control group (C group) received standard perioperative care without any prone position training.
  arm group label: Control group (C group)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Su Min, MD
  role: Principal Investigator
  affiliation: First Affiliated Hospital of Chongqing Medical University
  last name: Dong Zhang, Master
  phone: +86-023-89011069
  email: 848138113@qq.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: First Affiliated Hospital of Chongqing Medical University
  investigator full name: Min Su
  investigator title: Professor of Anesthesiology