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/NCT06026670</url>
    </required_header>
    <id_info>
      <org_study_id>HCB/2023/0147</org_study_id>
      <nct_id>NCT06026670</nct_id>
    </id_info>
    <brief_title>Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery</brief_title>
    <acronym>PEEP-RATS</acronym>
    <official_title>Optimal Positive End-Expiratory Pressure in Robotic-Assisted Thoracic Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospital Clinic of Barcelona</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospital Clinic of Barcelona</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>
        Minimally invasive thoracic surgery is increasingly popular. Recently, a new minimally&#xD;
        invasive thoracic approach, robotic-assisted thoracic surgery (RATS) has been developed. RATS&#xD;
        presents some advantages compared to VATS such as three-dimensional view of the surgical&#xD;
        field, its precisions facilitates the navigation in difficult to access spaces and eliminates&#xD;
        tremor which reduces learning curve and it may have a reduction of complications.&#xD;
  &#xD;
        During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also&#xD;
        a continuous tension capnothorax. CO2 insufflation with intrathoracic positive pressure has a&#xD;
        potential negative impact on the cardiorespiratory physiology. Moreover, CO2 insufflation and&#xD;
        one lung ventilation can produce ventilation induced lung injury which are related to&#xD;
        pulmonary postoperative complications (PPC).&#xD;
  &#xD;
        In order to reduce PPC and ventilation induced lung injury, lung protective strategies are&#xD;
        used which reduce atelectrauma and overdistension. These strategies consist of three main&#xD;
        pillars: use of low tidal volumes, performance of recruitment maneuvers and application of&#xD;
        optimal positive end-expiratory pressure (PEEP).&#xD;
  &#xD;
        However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical&#xD;
        studies with one-lung ventilation have reported improved oxygenation and ventilation when an&#xD;
        alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O.&#xD;
        Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation&#xD;
        and lung mechanics with individualized PEEP determined by using a PEEP decrement titration&#xD;
        trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS&#xD;
        may modify pulmonary compliance and optimal PEEP may be different from patients having VATS&#xD;
        resection.&#xD;
  &#xD;
        Even though both methods are habitual in the clinical practice, there are no studies of the&#xD;
        effect of an alveolar recruitment maneuver with individualized PEEP during one-lung&#xD;
        ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that&#xD;
        such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in&#xD;
        RATS compared with the establishment of a standardized PEEP. The investigators perform a&#xD;
        descriptive observational prospective study to test this hypothesis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Minimally invasive thoracic surgery is increasingly popular thanks to its potential benefits,&#xD;
        including less pain, reduced surgical stress and systemic inflammatory response and reduced&#xD;
        length of stay. In fact, video-assisted thoracoscopic surgery (VATS), is recommended for lung&#xD;
        resection in early stages in ERAS Guidelines. Recently, a new minimally invasive thoracic&#xD;
        approach, robotic-assisted thoracic surgery (RATS) has been developed. Its main indications&#xD;
        are lung resection, diaphragmatic repair, esophagectomy and resection of mediastinal tumor.&#xD;
        RATS presents some advantages compared to VATS such as three-dimensional view of the surgical&#xD;
        field, its precisions facilitates the navigation in difficult to access spaces, it improves&#xD;
        work ergonomics and eliminates tremor which reduces learning curve and it may have a&#xD;
        reduction of complications.&#xD;
  &#xD;
        During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also&#xD;
        a continuous tension capnothorax. Intrathoracic CO2 insufflation aims both to retract tissues&#xD;
        and expand the surgical field which gives a better view of intrathoracic structures but also&#xD;
        to facilitate anatomical dissection. Nevertheless, CO2 insufflation with intrathoracic&#xD;
        positive pressure has a potential negative impact on the cardiorespiratory physiology: it may&#xD;
        increase respiratory airway pressure, it may cause hypercapnia and respiratory acidosis and&#xD;
        can compromise the hemodynamics induced by the compression of the mediastinal vessels.&#xD;
        Moreover, CO2 insufflation and one lung ventilation can produce ventilation induced lung&#xD;
        injury which are related to pulmonary postoperative complications (PPC).&#xD;
  &#xD;
        In order to reduce PPC and ventilation induced lung injury, lung protective strategies are&#xD;
        used which reduce atelectrauma and overdistension. These strategies consist of three main&#xD;
        pillars: use of low tidal volumes, performance of recruitment maneuvers and application of&#xD;
        optimal positive end-expiratory pressure (PEEP).&#xD;
  &#xD;
        However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical&#xD;
        studies with one-lung ventilation have reported improved oxygenation and ventilation when an&#xD;
        alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O.&#xD;
        Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation&#xD;
        and lung mechanics with individualized PEEP determined by using a PEEP decrement titration&#xD;
        trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS&#xD;
        may modify pulmonary compliance and optimal PEEP may be different from patients having VATS&#xD;
        resection.&#xD;
  &#xD;
        Even though both methods are habitual in the clinical practice, there are no studies of the&#xD;
        effect of an alveolar recruitment maneuver with individualized PEEP during one-lung&#xD;
        ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that&#xD;
        such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in&#xD;
        RATS compared with the establishment of a standardized PEEP. The investigators perform a&#xD;
        descriptive observational prospective study to test this hypothesis.&#xD;
  &#xD;
        An individualized open lung approach which will consist in an alveolar recruitment maneuver&#xD;
        followed by a positive end-expiratory pressure adjusted to best respiratory system compliance&#xD;
        will be performed before and after capnothorax establishment.&#xD;
  &#xD;
        The main expected benefits will be improvement of oxygenation, ventilation and lung&#xD;
        mechanics.&#xD;
  &#xD;
        Recruitment maneuvers are part of daily practice during mechanical ventilation. During OLV,&#xD;
        they are done systematically, but little is known of optimal PEEP after it. When performed&#xD;
        correctly, considering its contraindications and appropriate monitoring they are safe&#xD;
        technique (9)&#xD;
  &#xD;
        This is a single center (Hospital Clínic de Barcelona), prospective, intraoperative&#xD;
        descriptive study. The hypothesis is to demonstrate the change in individualized optimal PEEP&#xD;
        before and after capnothorax during OLV and the improvement of ventilation and lung&#xD;
        mechanics. The primary objective is to assess the improvement of oxygenation, ventilation and&#xD;
        lung mechanics in patients ventilated with individualized PEEP during capnothorax.The&#xD;
        secondary objectives is to report the incidence of associated perioperative complications.&#xD;
        With the purpose of standardizing the optimal respiratory management of patients that undergo&#xD;
        robotic-assisted thoracic surgery (RATS).&#xD;
  &#xD;
        Based on previous studies, it was estimated that a total of 30 patients will be needed to&#xD;
        detect at least a 10% of static compliance during the establishment of capnothorax in&#xD;
        one-lung ventilation, with a 5% significance level and 80% power.&#xD;
  &#xD;
        Candidates for this study will be identified at the scheduled visit, prior to surgery, with&#xD;
        one of the anaesthetists of the Cardiothoracic Anaesthesia section of our hospital. This&#xD;
        visit is usually carried several days or weeks before surgery. Once a potential participant&#xD;
        has been identified, the main investigator (R.N.) will offer the possibility to explain the&#xD;
        study during the same scheduled visit and they will also provide written information&#xD;
        regarding our study. Those who, subsequently, express their potential desire to participate&#xD;
        in the study will also be offered an informed consent sheet for their signature. For those&#xD;
        still willing to consider their participation but not ready to decide whether to accept or&#xD;
        not their inclusion as part of the study, a second visit will be done once the patient is&#xD;
        admitted to the hospital the day before the surgery.&#xD;
  &#xD;
        The inclusion criteria are patients with ASA physical status I to III admitted to Hospital&#xD;
        Clínic de Barcelona undergoing elective RATS lung resection who agree to participate in the&#xD;
        study and sign the written consent form.&#xD;
  &#xD;
        The exclusion criteria are patients with age &lt;18 years, ASA physical status IV,&#xD;
        pneumonectomy, New York Heart Association III to IV, and preoperative hemoglobin &lt;10 mg/dL&#xD;
        will be excluded from the study. Moreover, patients in which recruitment maneuvers are&#xD;
        contraindicated will also be excluded from the study. Contraindications for recruitment&#xD;
        maneuvers are: history of pneumothorax, contralateral pulmonary bulla, hemodynamic&#xD;
        instability, lung emphysema, COPD, bronchopleural fistula, acute cor pulmonale or&#xD;
        intracranial hypertension .&#xD;
  &#xD;
        Data will be inspected and tested for distribution according to Kolmogorove Smirnov test.&#xD;
        Normally distributed data were compared between study arms using the unpaired T-student test,&#xD;
        whereas non-normally distributed data were compared using the Mann Whitney U test. All data&#xD;
        were summarised as mean or median as appropriate. Fisher's exact test was used for comparing&#xD;
        categorical data.&#xD;
  &#xD;
        All patients included in the study will be assigned an identification code. In a separated&#xD;
        database, the main investigator will have the relation between the identification code and&#xD;
        the patient's clinical record number. All investigators of the study will have access to the&#xD;
        coded number database that will be stored in a shared Drive document, and the main&#xD;
        investigator will be responsible for it. Both database will be stored 5 years after study&#xD;
        completion.&#xD;
  &#xD;
        Individual data, such as participant baseline medical conditions, type of surgery,&#xD;
        respiratory parameters, results from arterial gasometries samples and postoperative pulmonary&#xD;
        complications until the 7th day from the admission will be recorded in order to assess the&#xD;
        benefit of optimal PEEP before and after capnothorax stablishment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 3, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>7 Days</target_duration>
    <primary_outcome>
      <measure>Optimal PEEP</measure>
      <time_frame>4 hours</time_frame>
      <description>Assess the improvement of oxygenation, ventilation and lung mechanics in patients ventilated with individualized PEEP during capnothorax.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Perioperative complications</measure>
      <time_frame>7 days</time_frame>
      <description>Report the incidence of associated perioperative complications</description>
    </secondary_outcome>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Ventilator-Induced Lung Injury</condition>
    <eligibility>
      <study_pop>
        <textblock>
          ASA physical status I to III admitted to Hospital Clínic de Barcelona undergoing elective&#xD;
          RATS lung resection who agree to participate in the study and sign the written consent form&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ASA physical status I to III&#xD;
  &#xD;
            -  Admitted to Hospital Clínic de Barcelona&#xD;
  &#xD;
            -  Undergoing elective RATS lung resection&#xD;
  &#xD;
            -  Who agree to participate in the study and sign the written consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with age &lt;18 years&#xD;
  &#xD;
            -  ASA physical status IV&#xD;
  &#xD;
            -  Pneumonectomy&#xD;
  &#xD;
            -  New York Heart Association III to IV&#xD;
  &#xD;
            -  Preoperative hemoglobin &lt;10 mg/dL will be excluded from the study.&#xD;
  &#xD;
            -  Patients in which recruitment maneuvers are contraindicated (history of pneumothorax,&#xD;
               contralateral pulmonary bulla, hemodynamic instability, lung emphysema, COPD,&#xD;
               bronchopleural fistula, acute cor pulmonale or intracranial hypertension).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>120 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Ricard Navarro, MD</last_name>
      <phone>+34629152924</phone>
      <email>rnavarr1@clinic.cat</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alvaro Bunuel, MS</last_name>
      <phone>+34644218688</phone>
      <email>alvarobunuelplana@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Ricard Navarro</name>
        <address>
          <city>Barcelona</city>
          <zip>08036</zip>
          <country>Spain</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ricard Navarro</last_name>
        <phone>+34629152924</phone>
        <email>rnavarr1@clinic.cat</email>
      </contact>
      <contact_backup>
        <last_name>Alvaro Bunuel</last_name>
        <phone>+34644218688</phone>
        <email>alvarobunuelplana@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Ricard Navarro</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Alvaro Bunuel</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 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 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Optimal PEEP</keyword>
    <keyword>Robotic-Assisted Thoracic Surgery.</keyword>
    <keyword>Recruitment Maneuvers</keyword>
    <keyword>Mechanical Ventilation</keyword>
    <keyword>One-lung ventilation</keyword>
    <keyword>Capnothorax</keyword>
    <keyword>Positive End-Expiratory Pressure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Injury</mesh_term>
      <mesh_term>Ventilator-Induced Lung Injury</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/NCT06026670
  org study id: HCB/2023/0147
  nct id: NCT06026670
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Minimally invasive thoracic surgery is increasingly popular. Recently, a new minimally
        invasive thoracic approach, robotic-assisted thoracic surgery (RATS) has been developed. RATS
        presents some advantages compared to VATS such as three-dimensional view of the surgical
        field, its precisions facilitates the navigation in difficult to access spaces and eliminates
        tremor which reduces learning curve and it may have a reduction of complications.
  
        During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also
        a continuous tension capnothorax. CO2 insufflation with intrathoracic positive pressure has a
        potential negative impact on the cardiorespiratory physiology. Moreover, CO2 insufflation and
        one lung ventilation can produce ventilation induced lung injury which are related to
        pulmonary postoperative complications (PPC).
  
        In order to reduce PPC and ventilation induced lung injury, lung protective strategies are
        used which reduce atelectrauma and overdistension. These strategies consist of three main
        pillars: use of low tidal volumes, performance of recruitment maneuvers and application of
        optimal positive end-expiratory pressure (PEEP).
  
        However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical
        studies with one-lung ventilation have reported improved oxygenation and ventilation when an
        alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O.
        Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation
        and lung mechanics with individualized PEEP determined by using a PEEP decrement titration
        trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS
        may modify pulmonary compliance and optimal PEEP may be different from patients having VATS
        resection.
  
        Even though both methods are habitual in the clinical practice, there are no studies of the
        effect of an alveolar recruitment maneuver with individualized PEEP during one-lung
        ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that
        such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in
        RATS compared with the establishment of a standardized PEEP. The investigators perform a
        descriptive observational prospective study to test this hypothesis.
  Minimally invasive thoracic surgery is increasingly popular thanks to its potential benefits,
        including less pain, reduced surgical stress and systemic inflammatory response and reduced
        length of stay. In fact, video-assisted thoracoscopic surgery (VATS), is recommended for lung
        resection in early stages in ERAS Guidelines. Recently, a new minimally invasive thoracic
        approach, robotic-assisted thoracic surgery (RATS) has been developed. Its main indications
        are lung resection, diaphragmatic repair, esophagectomy and resection of mediastinal tumor.
        RATS presents some advantages compared to VATS such as three-dimensional view of the surgical
        field, its precisions facilitates the navigation in difficult to access spaces, it improves
        work ergonomics and eliminates tremor which reduces learning curve and it may have a
        reduction of complications.
  
        During RATS and differently from VATS, not only one lung ventilation (OLV) is needed but also
        a continuous tension capnothorax. Intrathoracic CO2 insufflation aims both to retract tissues
        and expand the surgical field which gives a better view of intrathoracic structures but also
        to facilitate anatomical dissection. Nevertheless, CO2 insufflation with intrathoracic
        positive pressure has a potential negative impact on the cardiorespiratory physiology: it may
        increase respiratory airway pressure, it may cause hypercapnia and respiratory acidosis and
        can compromise the hemodynamics induced by the compression of the mediastinal vessels.
        Moreover, CO2 insufflation and one lung ventilation can produce ventilation induced lung
        injury which are related to pulmonary postoperative complications (PPC).
  
        In order to reduce PPC and ventilation induced lung injury, lung protective strategies are
        used which reduce atelectrauma and overdistension. These strategies consist of three main
        pillars: use of low tidal volumes, performance of recruitment maneuvers and application of
        optimal positive end-expiratory pressure (PEEP).
  
        However, optimal PEEP levels and actual effects of PEEP are not clear. Several clinical
        studies with one-lung ventilation have reported improved oxygenation and ventilation when an
        alveolar recruitment maneuver is performed with a standardized PEEP of 5 to 10 cm·H2O.
        Nevertheless, other studies observe during one-lung ventilation improvements in oxygenation
        and lung mechanics with individualized PEEP determined by using a PEEP decrement titration
        trial after an alveolar recruitment maneuver. The effect of a tension capnothorax during RATS
        may modify pulmonary compliance and optimal PEEP may be different from patients having VATS
        resection.
  
        Even though both methods are habitual in the clinical practice, there are no studies of the
        effect of an alveolar recruitment maneuver with individualized PEEP during one-lung
        ventilation in Robotic-Assisted Thoracic Surgery (RATS). The investigators hypothesized that
        such a procedure would improve oxygenation and lung mechanics during one-lung ventilation in
        RATS compared with the establishment of a standardized PEEP. The investigators perform a
        descriptive observational prospective study to test this hypothesis.
  
        An individualized open lung approach which will consist in an alveolar recruitment maneuver
        followed by a positive end-expiratory pressure adjusted to best respiratory system compliance
        will be performed before and after capnothorax establishment.
  
        The main expected benefits will be improvement of oxygenation, ventilation and lung
        mechanics.
  
        Recruitment maneuvers are part of daily practice during mechanical ventilation. During OLV,
        they are done systematically, but little is known of optimal PEEP after it. When performed
        correctly, considering its contraindications and appropriate monitoring they are safe
        technique (9)
  
        This is a single center (Hospital Clínic de Barcelona), prospective, intraoperative
        descriptive study. The hypothesis is to demonstrate the change in individualized optimal PEEP
        before and after capnothorax during OLV and the improvement of ventilation and lung
        mechanics. The primary objective is to assess the improvement of oxygenation, ventilation and
        lung mechanics in patients ventilated with individualized PEEP during capnothorax.The
        secondary objectives is to report the incidence of associated perioperative complications.
        With the purpose of standardizing the optimal respiratory management of patients that undergo
        robotic-assisted thoracic surgery (RATS).
  
        Based on previous studies, it was estimated that a total of 30 patients will be needed to
        detect at least a 10% of static compliance during the establishment of capnothorax in
        one-lung ventilation, with a 5% significance level and 80% power.
  
        Candidates for this study will be identified at the scheduled visit, prior to surgery, with
        one of the anaesthetists of the Cardiothoracic Anaesthesia section of our hospital. This
        visit is usually carried several days or weeks before surgery. Once a potential participant
        has been identified, the main investigator (R.N.) will offer the possibility to explain the
        study during the same scheduled visit and they will also provide written information
        regarding our study. Those who, subsequently, express their potential desire to participate
        in the study will also be offered an informed consent sheet for their signature. For those
        still willing to consider their participation but not ready to decide whether to accept or
        not their inclusion as part of the study, a second visit will be done once the patient is
        admitted to the hospital the day before the surgery.
  
        The inclusion criteria are patients with ASA physical status I to III admitted to Hospital
        Clínic de Barcelona undergoing elective RATS lung resection who agree to participate in the
        study and sign the written consent form.
  
        The exclusion criteria are patients with age <18 years, ASA physical status IV,
        pneumonectomy, New York Heart Association III to IV, and preoperative hemoglobin <10 mg/dL
        will be excluded from the study. Moreover, patients in which recruitment maneuvers are
        contraindicated will also be excluded from the study. Contraindications for recruitment
        maneuvers are: history of pneumothorax, contralateral pulmonary bulla, hemodynamic
        instability, lung emphysema, COPD, bronchopleural fistula, acute cor pulmonale or
        intracranial hypertension .
  
        Data will be inspected and tested for distribution according to Kolmogorove Smirnov test.
        Normally distributed data were compared between study arms using the unpaired T-student test,
        whereas non-normally distributed data were compared using the Mann Whitney U test. All data
        were summarised as mean or median as appropriate. Fisher's exact test was used for comparing
        categorical data.
  
        All patients included in the study will be assigned an identification code. In a separated
        database, the main investigator will have the relation between the identification code and
        the patient's clinical record number. All investigators of the study will have access to the
        coded number database that will be stored in a shared Drive document, and the main
        investigator will be responsible for it. Both database will be stored 5 years after study
        completion.
  
        Individual data, such as participant baseline medical conditions, type of surgery,
        respiratory parameters, results from arterial gasometries samples and postoperative pulmonary
        complications until the 7th day from the admission will be recorded in order to assess the
        benefit of optimal PEEP before and after capnothorax stablishment.
  observational model: Other
  time perspective: Prospective
  measure: Optimal PEEP
  time frame: 4 hours
  description: Assess the improvement of oxygenation, ventilation and lung mechanics in patients ventilated with individualized PEEP during capnothorax.
  measure: Perioperative complications
  time frame: 7 days
  description: Report the incidence of associated perioperative complications
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 120 Years
  last name: Ricard Navarro, MD
  phone: +34629152924
  email: rnavarr1@clinic.cat
  last name: Alvaro Bunuel, MS
  phone: +34644218688
  email: alvarobunuelplana@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Lung Injury
  mesh term: Ventilator-Induced Lung Injury
  sharing ipd: No