<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/NCT02989415</url>
  </required_header>
  <id_info>
    <org_study_id>AVATaR</org_study_id>
    <nct_id>NCT02989415</nct_id>
  </id_info>
  <brief_title>Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery</brief_title>
  <acronym>AVATaR</acronym>
  <official_title>Assessment of Ventilatory Management During General Anesthesia for Robotic Surgery and Its Effects on Postoperative Pulmonary Complications: A Prospective Observational Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Israelita Albert Einstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Genova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Israelita Albert Einstein</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>
      The aim of this study is to assess the incidence of postoperative pulmonary complications in&#xD;
      patients undergoing mechanical ventilation during general anesthesia for robotic surgery, to&#xD;
      characterize current practices of mechanical ventilation and to evaluate a possible&#xD;
      association between ventilatory parameters and postoperative pulmonary complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research questions:&#xD;
&#xD;
        1. What is the incidence of PPC in patients undergoing mechanical ventilation during&#xD;
           general anesthesia for robotic surgery?&#xD;
&#xD;
        2. Are the outcomes in patients undergoing robotic surgery dependent on ventilation&#xD;
           practice and surgical positioning?&#xD;
&#xD;
        3. What is the incidence of patients at high risk for PPC undergoing robotic surgery&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      In this international observational study, consecutive patients undergoing mechanical&#xD;
      ventilation for robotic surgery are eligible for participation. Patients in participating&#xD;
      centers will be screened on a daily basis. Patients undergoing mechanical ventilation for&#xD;
      robotic surgery will be included during a 30-day period. The inclusion period will be&#xD;
      flexible for participating centers and determined at a later stage together with the&#xD;
      study-coordinator.&#xD;
&#xD;
      Time points of data collection:&#xD;
&#xD;
        1. Demographic data and baseline data, including severity scores (e.g. ASA) and ARISCAT,&#xD;
           are collected from the clinical files on the day of surgery&#xD;
&#xD;
        2. Ventilation settings, gas exchange variables, positioning and vital parameters are&#xD;
           collected hourly during surgery&#xD;
&#xD;
        3. Chest radiography data from available chest X-rays (i.e., no extra chest X-rays are&#xD;
           obtained)&#xD;
&#xD;
        4. Predefined complications are recorded from medical chart until the first five&#xD;
           postoperative days, discharge from hospital or death, whatever comes first&#xD;
&#xD;
        5. Length of hospital stay, and hospital mortality&#xD;
&#xD;
      Centres: The investigators aim to recruit 20 - 50 centers worldwide.&#xD;
&#xD;
      Ethics Approval: National coordinators will be responsible for clarifying the need for ethics&#xD;
      approval and applying for this where appropriate according to local policy. Centres will not&#xD;
      be permitted to record data unless ethics approval or an equivalent waiver is in place. The&#xD;
      investigators expect that in most, if not every participating country, a patient informed&#xD;
      consent is not be required.&#xD;
&#xD;
      Monitoring: Due to the observational nature of the study, a DSMB is not be necessary.&#xD;
&#xD;
      Study Population: Adult patients undergoing mechanical ventilation for robotic surgery.&#xD;
&#xD;
      Data Collection: Data will be collected at inclusion, during surgery and every day during&#xD;
      five days, and day of hospital discharge. Data will be coded by a patient identification&#xD;
      number (PIN) of which the code will be kept safe at the local sites. The data will be&#xD;
      transcribed by local investigators onto an internet based electronic CRF.&#xD;
&#xD;
      Sample Size Calculation: A formal sample size will not be calculated, seen the largely&#xD;
      descriptive character of this investigation. Data from 500 patients is expected to be&#xD;
      collected, which will be sufficient to test the hypotheses.&#xD;
&#xD;
      Statistical Analysis: Patient characteristics will be compared and described by appropriate&#xD;
      statistics. Student's t-test or Mann-Whitney U-tests are used to compare continuous variables&#xD;
      and chi-squared tests are used for categorical variables. Data are expressed as means (SD),&#xD;
      medians (interquartile range) and proportions as appropriate. Comparisons between and within&#xD;
      groups are performed using one-way ANOVA and post-hoc analyses for continuous variables.&#xD;
&#xD;
      The primary analysis concerns the determination of the incidence of postoperative pulmonary&#xD;
      complications in patients undergoing mechanical ventilation for robotic surgery.&#xD;
&#xD;
      To identify potential factors associated with outcome like development of postoperative&#xD;
      pulmonary complications, or death, univariable analyses will be performed. A multi-level&#xD;
      multivariable logistic regression model will be used to identify independent risk factors. A&#xD;
      gradual approach will be used to enter new terms into the model, with a limit of p &lt; 0.2 to&#xD;
      enter the terms. Time to event variables will be analyzed using Cox regression and visualized&#xD;
      by Kaplan-Meier.&#xD;
&#xD;
      Organization: The study is conducted by the PROtective VEntilation Network (PROVENet).&#xD;
      National co-ordinators will lead the project within individual nations and identify&#xD;
      participating hospitals, translate study paperwork, distribute study paperwork and ensure&#xD;
      necessary regulatory approvals are in place. They provide assistance to the participating&#xD;
      clinical sites in trial management, record keeping and data management. Local coordinators in&#xD;
      each site will supervise data collection and ensure adherence to Good Clinical Practice&#xD;
      during the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 3, 2017</start_date>
  <completion_date type="Actual">January 15, 2020</completion_date>
  <primary_completion_date type="Actual">March 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of postoperative pulmonary complications</measure>
    <time_frame>Five days or until hospital discharge, whichever occurs first</time_frame>
    <description>Composite of five postoperative pulmonary complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation practice</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>Mechanical ventilation practice in patients submitted to general anesthesia for robotic surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation practice and postoperative pulmonary complications</measure>
    <time_frame>Five days or until hospital discharge, whichever occurs first</time_frame>
    <description>Association between mechanical ventilation practice and development of postoperative pulmonary complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical positioning and ventilation</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>Association between surgical positioning and ventilatory parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients at high risk for postoperative pulmonary complications</measure>
    <time_frame>Pre-operatively</time_frame>
    <description>Incidence of patients at high risk for postoperative pulmonary complications according to the ARISCAT score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation practice and intraoperative complications</measure>
    <time_frame>Intraoperatively</time_frame>
    <description>Association between mechanical ventilation practice and development of intraoperative complications</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1015</enrollment>
  <condition>Robotic Surgery</condition>
  <condition>Mechanical Ventilation</condition>
  <arm_group>
    <arm_group_label>Mechanical Ventilation</arm_group_label>
    <description>Patients undergoing mechanical ventilation during robotic surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mechanical Ventilation</intervention_name>
    <description>Mechanical ventilation during robotic surgery</description>
    <arm_group_label>Mechanical Ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients undergoing mechanical ventilation during general anesthesia for robotic&#xD;
        surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  All surgical procedures performed under general anesthesia for robotic surgery,&#xD;
             including head and neck operations, chest, cardiac, and abdominal surgeries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any procedure during pregnancy&#xD;
&#xD;
          -  Procedures outside of the operating room&#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>Ary Serpa Neto, MD, MSc, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Critical Care Medicine, Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Veronica NF Queiroz, MD</last_name>
    <role>Study Director</role>
    <affiliation>AVATaR Study Coordinator, Anesthesiology, Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luiz Guilherme V da Costa, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology, Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rogério P Barbosa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology, Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Flavio Takaoka, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology, Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Luc de Baerdemaeker, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology and Perioperative Medicine; Ghent University Hospital - Ghent University; Ghent, Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel S Cesar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology, Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ulisses C D'Orto, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology, Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>José Roberto Galdi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology, Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vijaya Gottumukkala, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology and Perioperative Medicine; The University of Texas MD Anderson Cancer Center; Houston, Texas, USA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sabrine NT Hemmes, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesiology; Academic Medical Center; University of Amsterdam; Amsterdam, The Netherlands</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Markus W Hollmann, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesiology; Academic Medical Center; University of Amsterdam; Amsterdam, The Netherlands</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alain Kalmar, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesia and Intensive Care Medicine; Maria Middelares Hospital; Ghent, Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Renato M Mariano, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology, Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Idit Matot, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Anesthesiology, Intensive Care and Pain; Tel Aviv Medical Center and the Sackler Faculty of Medicine; Tel Aviv University; Tel Aviv, Israel</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guido Mazzinari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesiology; Manises General Hospital; Manises, Spain</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gary H Mills, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anaesthesia and Critical Care Medicine; Sheffield Teaching Hospital; Sheffield, UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Irimar P Posso, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology, Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alexandre Teruya, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anesthesiology, Hospital Israelita Albert Einstein</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcos Francisco Vidal Melo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesia, Critical Care and Pain Medicine; Massachusetts General Hospital; Harvard Medical School; Boston, MA, USA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paolo Pelosi, MD, FERS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Surgical Sciences and Integrated Diagnostics; IRCCS San Martino IST; University of Genoa; Genoa, Italy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcelo Gama de Abreu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pulmonary Engineering Group; Department of Anesthesiology and Intensive Care Medicine; University Hospital Carl Gustav Carus; Technische Universität Dresden; Dresden, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcus J Schultz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Intensive Care; Academic Medical Center; University of Amsterdam; Amsterdam. The Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maria Middelares Hospital</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Israelita Albert Einstein</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <state>North Rhine-Westphalia</state>
        <zip>0511</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Essen-Mitte</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petah Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel-Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel-Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario San Carlos</name>
      <address>
        <city>Madrid</city>
        <state>Community Of Madrid</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic of Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.provenet.eu</url>
    <description>PROtective VENtilation Network</description>
  </link>
  <link>
    <url>http://www.einstein.br</url>
    <description>Hospital Israelita Albert Einstein</description>
  </link>
  <results_reference>
    <citation>Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4. Erratum In: Lancet Respir Med. 2016 Jun;4(6):e34.</citation>
    <PMID>26947624</PMID>
  </results_reference>
  <results_reference>
    <citation>Serpa Neto A, Schultz MJ, Gama de Abreu M. Intraoperative ventilation strategies to prevent postoperative pulmonary complications: Systematic review, meta-analysis, and trial sequential analysis. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):331-40. doi: 10.1016/j.bpa.2015.09.002. Epub 2015 Sep 18.</citation>
    <PMID>26643098</PMID>
  </results_reference>
  <results_reference>
    <citation>Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Biehl M, Binnekade JM, Canet J, Fernandez-Bustamante A, Futier E, Gajic O, Hedenstierna G, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Putensen C, Ranieri M, Scavonetto F, Schilling T, Schmid W, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network Investigators. Protective versus Conventional Ventilation for Surgery: A Systematic Review and Individual Patient Data Meta-analysis. Anesthesiology. 2015 Jul;123(1):66-78. doi: 10.1097/ALN.0000000000000706.</citation>
    <PMID>25978326</PMID>
  </results_reference>
  <results_reference>
    <citation>Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Moine P, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network investigators. Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis. Lancet Respir Med. 2014 Dec;2(12):1007-15. doi: 10.1016/S2213-2600(14)70228-0. Epub 2014 Nov 13. Erratum In: Lancet Respir Med. 2014 Dec;2(12):e23.</citation>
    <PMID>25466352</PMID>
  </results_reference>
  <results_reference>
    <citation>Hemmes SN, Serpa Neto A, Schultz MJ. Intraoperative ventilatory strategies to prevent postoperative pulmonary complications: a meta-analysis. Curr Opin Anaesthesiol. 2013 Apr;26(2):126-33. doi: 10.1097/ACO.0b013e32835e1242.</citation>
    <PMID>23385321</PMID>
  </results_reference>
  <results_reference>
    <citation>Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.</citation>
    <PMID>23093163</PMID>
  </results_reference>
  <results_reference>
    <citation>Danic MJ, Chow M, Alexander G, Bhandari A, Menon M, Brown M. Anesthesia considerations for robotic-assisted laparoscopic prostatectomy: a review of 1,500 cases. J Robot Surg. 2007;1(2):119-23. doi: 10.1007/s11701-007-0024-z. Epub 2007 May 30.</citation>
    <PMID>25484947</PMID>
  </results_reference>
  <results_reference>
    <citation>Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.</citation>
    <PMID>21045639</PMID>
  </results_reference>
  <results_reference>
    <citation>Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.</citation>
    <PMID>25058504</PMID>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>February 10, 2020</last_update_submitted>
  <last_update_submitted_qc>February 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Israelita Albert Einstein</investigator_affiliation>
    <investigator_full_name>Ary Serpa Neto</investigator_full_name>
    <investigator_title>MD, MSc, PhD</investigator_title>
  </responsible_party>
  <keyword>Anesthesia</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Robotic Surgery</keyword>
  <keyword>Postoperative Pulmonary Complications</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data will be available for substudies suggested by members of the collaboration.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After the publication of the main manuscript</ipd_time_frame>
    <ipd_access_criteria>The data will be available for substudies suggested by members of the collaboration.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT02989415/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT02989415/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02989415
org study id: AVATaR
nct id: NCT02989415
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to assess the incidence of postoperative pulmonary complications in
      patients undergoing mechanical ventilation during general anesthesia for robotic surgery, to
      characterize current practices of mechanical ventilation and to evaluate a possible
      association between ventilatory parameters and postoperative pulmonary complications.
Research questions:

        1. What is the incidence of PPC in patients undergoing mechanical ventilation during
           general anesthesia for robotic surgery?

        2. Are the outcomes in patients undergoing robotic surgery dependent on ventilation
           practice and surgical positioning?

        3. What is the incidence of patients at high risk for PPC undergoing robotic surgery

      Methods:

      In this international observational study, consecutive patients undergoing mechanical
      ventilation for robotic surgery are eligible for participation. Patients in participating
      centers will be screened on a daily basis. Patients undergoing mechanical ventilation for
      robotic surgery will be included during a 30-day period. The inclusion period will be
      flexible for participating centers and determined at a later stage together with the
      study-coordinator.

      Time points of data collection:

        1. Demographic data and baseline data, including severity scores (e.g. ASA) and ARISCAT,
           are collected from the clinical files on the day of surgery

        2. Ventilation settings, gas exchange variables, positioning and vital parameters are
           collected hourly during surgery

        3. Chest radiography data from available chest X-rays (i.e., no extra chest X-rays are
           obtained)

        4. Predefined complications are recorded from medical chart until the first five
           postoperative days, discharge from hospital or death, whatever comes first

        5. Length of hospital stay, and hospital mortality

      Centres: The investigators aim to recruit 20 - 50 centers worldwide.

      Ethics Approval: National coordinators will be responsible for clarifying the need for ethics
      approval and applying for this where appropriate according to local policy. Centres will not
      be permitted to record data unless ethics approval or an equivalent waiver is in place. The
      investigators expect that in most, if not every participating country, a patient informed
      consent is not be required.

      Monitoring: Due to the observational nature of the study, a DSMB is not be necessary.

      Study Population: Adult patients undergoing mechanical ventilation for robotic surgery.

      Data Collection: Data will be collected at inclusion, during surgery and every day during
      five days, and day of hospital discharge. Data will be coded by a patient identification
      number (PIN) of which the code will be kept safe at the local sites. The data will be
      transcribed by local investigators onto an internet based electronic CRF.

      Sample Size Calculation: A formal sample size will not be calculated, seen the largely
      descriptive character of this investigation. Data from 500 patients is expected to be
      collected, which will be sufficient to test the hypotheses.

      Statistical Analysis: Patient characteristics will be compared and described by appropriate
      statistics. Student's t-test or Mann-Whitney U-tests are used to compare continuous variables
      and chi-squared tests are used for categorical variables. Data are expressed as means (SD),
      medians (interquartile range) and proportions as appropriate. Comparisons between and within
      groups are performed using one-way ANOVA and post-hoc analyses for continuous variables.

      The primary analysis concerns the determination of the incidence of postoperative pulmonary
      complications in patients undergoing mechanical ventilation for robotic surgery.

      To identify potential factors associated with outcome like development of postoperative
      pulmonary complications, or death, univariable analyses will be performed. A multi-level
      multivariable logistic regression model will be used to identify independent risk factors. A
      gradual approach will be used to enter new terms into the model, with a limit of p < 0.2 to
      enter the terms. Time to event variables will be analyzed using Cox regression and visualized
      by Kaplan-Meier.

      Organization: The study is conducted by the PROtective VEntilation Network (PROVENet).
      National co-ordinators will lead the project within individual nations and identify
      participating hospitals, translate study paperwork, distribute study paperwork and ensure
      necessary regulatory approvals are in place. They provide assistance to the participating
      clinical sites in trial management, record keeping and data management. Local coordinators in
      each site will supervise data collection and ensure adherence to Good Clinical Practice
      during the trial.
observational model: Cohort
time perspective: Prospective
measure: Incidence of postoperative pulmonary complications
time frame: Five days or until hospital discharge, whichever occurs first
description: Composite of five postoperative pulmonary complications
measure: Mechanical ventilation practice
time frame: Intraoperatively
description: Mechanical ventilation practice in patients submitted to general anesthesia for robotic surgery
measure: Mechanical ventilation practice and postoperative pulmonary complications
time frame: Five days or until hospital discharge, whichever occurs first
description: Association between mechanical ventilation practice and development of postoperative pulmonary complications
measure: Surgical positioning and ventilation
time frame: Intraoperatively
description: Association between surgical positioning and ventilatory parameters
measure: Patients at high risk for postoperative pulmonary complications
time frame: Pre-operatively
description: Incidence of patients at high risk for postoperative pulmonary complications according to the ARISCAT score
measure: Mechanical ventilation practice and intraoperative complications
time frame: Intraoperatively
description: Association between mechanical ventilation practice and development of intraoperative complications
arm group label: Mechanical Ventilation
description: Patients undergoing mechanical ventilation during robotic surgery
intervention type: Other
intervention name: Mechanical Ventilation
description: Mechanical ventilation during robotic surgery
arm group label: Mechanical Ventilation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ary Serpa Neto, MD, MSc, PhD
role: Study Chair
affiliation: Department of Critical Care Medicine, Hospital Israelita Albert Einstein
last name: Veronica NF Queiroz, MD
role: Study Director
affiliation: AVATaR Study Coordinator, Anesthesiology, Hospital Israelita Albert Einstein
last name: Luiz Guilherme V da Costa, MD, PhD
role: Principal Investigator
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
last name: Rogério P Barbosa, MD
role: Principal Investigator
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
last name: Flavio Takaoka, MD
role: Principal Investigator
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
last name: Luc de Baerdemaeker, MD, PhD
role: Principal Investigator
affiliation: Department of Anesthesiology and Perioperative Medicine; Ghent University Hospital - Ghent University; Ghent, Belgium
last name: Daniel S Cesar, MD
role: Principal Investigator
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
last name: Ulisses C D'Orto, MD
role: Principal Investigator
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
last name: José Roberto Galdi, MD, PhD
role: Principal Investigator
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
last name: Vijaya Gottumukkala, MD, PhD
role: Principal Investigator
affiliation: Department of Anesthesiology and Perioperative Medicine; The University of Texas MD Anderson Cancer Center; Houston, Texas, USA
last name: Sabrine NT Hemmes, MD, PhD
role: Principal Investigator
affiliation: Department of Anaesthesiology; Academic Medical Center; University of Amsterdam; Amsterdam, The Netherlands
last name: Markus W Hollmann, MD, PhD
role: Principal Investigator
affiliation: Department of Anaesthesiology; Academic Medical Center; University of Amsterdam; Amsterdam, The Netherlands
last name: Alain Kalmar, MD, PhD
role: Principal Investigator
affiliation: Department of Anesthesia and Intensive Care Medicine; Maria Middelares Hospital; Ghent, Belgium
last name: Renato M Mariano, MD, PhD
role: Principal Investigator
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
last name: Idit Matot, MD, PhD
role: Principal Investigator
affiliation: Division of Anesthesiology, Intensive Care and Pain; Tel Aviv Medical Center and the Sackler Faculty of Medicine; Tel Aviv University; Tel Aviv, Israel
last name: Guido Mazzinari, MD
role: Principal Investigator
affiliation: Department of Anaesthesiology; Manises General Hospital; Manises, Spain
last name: Gary H Mills, MD, PhD
role: Principal Investigator
affiliation: Department of Anaesthesia and Critical Care Medicine; Sheffield Teaching Hospital; Sheffield, UK
last name: Irimar P Posso, MD, PhD
role: Principal Investigator
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
last name: Alexandre Teruya, MD, PhD
role: Principal Investigator
affiliation: Anesthesiology, Hospital Israelita Albert Einstein
last name: Marcos Francisco Vidal Melo, MD, PhD
role: Principal Investigator
affiliation: Department of Anesthesia, Critical Care and Pain Medicine; Massachusetts General Hospital; Harvard Medical School; Boston, MA, USA
last name: Paolo Pelosi, MD, FERS
role: Principal Investigator
affiliation: Department of Surgical Sciences and Integrated Diagnostics; IRCCS San Martino IST; University of Genoa; Genoa, Italy
last name: Marcelo Gama de Abreu, MD, PhD
role: Principal Investigator
affiliation: Pulmonary Engineering Group; Department of Anesthesiology and Intensive Care Medicine; University Hospital Carl Gustav Carus; Technische Universität Dresden; Dresden, Germany
last name: Marcus J Schultz, MD, PhD
role: Principal Investigator
affiliation: Department of Intensive Care; Academic Medical Center; University of Amsterdam; Amsterdam. The Netherlands
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Brazil
country: Germany
country: Israel
country: Spain
country: United States
url: http://www.provenet.eu
description: PROtective VENtilation Network
url: http://www.einstein.br
description: Hospital Israelita Albert Einstein
citation: Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4. Erratum In: Lancet Respir Med. 2016 Jun;4(6):e34.
PMID: 26947624
citation: Serpa Neto A, Schultz MJ, Gama de Abreu M. Intraoperative ventilation strategies to prevent postoperative pulmonary complications: Systematic review, meta-analysis, and trial sequential analysis. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):331-40. doi: 10.1016/j.bpa.2015.09.002. Epub 2015 Sep 18.
PMID: 26643098
citation: Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Biehl M, Binnekade JM, Canet J, Fernandez-Bustamante A, Futier E, Gajic O, Hedenstierna G, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Putensen C, Ranieri M, Scavonetto F, Schilling T, Schmid W, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network Investigators. Protective versus Conventional Ventilation for Surgery: A Systematic Review and Individual Patient Data Meta-analysis. Anesthesiology. 2015 Jul;123(1):66-78. doi: 10.1097/ALN.0000000000000706.
PMID: 25978326
citation: Serpa Neto A, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Hollmann MW, Jaber S, Kozian A, Licker M, Lin WQ, Moine P, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Gama de Abreu M, Pelosi P, Schultz MJ; PROVE Network investigators. Incidence of mortality and morbidity related to postoperative lung injury in patients who have undergone abdominal or thoracic surgery: a systematic review and meta-analysis. Lancet Respir Med. 2014 Dec;2(12):1007-15. doi: 10.1016/S2213-2600(14)70228-0. Epub 2014 Nov 13. Erratum In: Lancet Respir Med. 2014 Dec;2(12):e23.
PMID: 25466352
citation: Hemmes SN, Serpa Neto A, Schultz MJ. Intraoperative ventilatory strategies to prevent postoperative pulmonary complications: a meta-analysis. Curr Opin Anaesthesiol. 2013 Apr;26(2):126-33. doi: 10.1097/ACO.0b013e32835e1242.
PMID: 23385321
citation: Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.
PMID: 23093163
citation: Danic MJ, Chow M, Alexander G, Bhandari A, Menon M, Brown M. Anesthesia considerations for robotic-assisted laparoscopic prostatectomy: a review of 1,500 cases. J Robot Surg. 2007;1(2):119-23. doi: 10.1007/s11701-007-0024-z. Epub 2007 May 30.
PMID: 25484947
citation: Canet J, Gallart L, Gomar C, Paluzie G, Valles J, Castillo J, Sabate S, Mazo V, Briones Z, Sanchis J; ARISCAT Group. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010 Dec;113(6):1338-50. doi: 10.1097/ALN.0b013e3181fc6e0a.
PMID: 21045639
citation: Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.
PMID: 25058504
responsible party type: Principal Investigator
investigator affiliation: Hospital Israelita Albert Einstein
investigator full name: Ary Serpa Neto
investigator title: MD, MSc, PhD
sharing ipd: Yes
ipd description: The data will be available for substudies suggested by members of the collaboration.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: After the publication of the main manuscript
ipd access criteria: The data will be available for substudies suggested by members of the collaboration.
provided document: 
provided document: 