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/NCT06033404</url>
    </required_header>
    <id_info>
      <org_study_id>ARIA - 40/INT//2023</org_study_id>
      <nct_id>NCT06033404</nct_id>
    </id_info>
    <brief_title>Anesthesia and Critical Care Registry</brief_title>
    <acronym>ARIA</acronym>
    <official_title>Registry of Patients Undergoing Anesthesia or Intensive Care Maneuvers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Università Vita-Salute San Raffaele</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Università Vita-Salute San Raffaele</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>
        In recent decades, knowledge in the anesthesiology field has increasingly expanded, allowing&#xD;
        for the refinement of monitoring techniques, therapies, and local-regional anesthesia&#xD;
        maneuvers, and for the extension of care to a larger number of patients, including those&#xD;
        previously excluded due to advanced age or comorbidities. Similarly, Intensive care&#xD;
        management has continuously evolved, following innovations in the field of drugs and with the&#xD;
        great diffusion of extracorporeal supports. The fundamental importance of registry studies&#xD;
        has been recognized in this context to rapidly generate reliable data and improve the quality&#xD;
        of care.&#xD;
  &#xD;
        This prospective observational study is aimed at collecting data of all patients (expected&#xD;
        300,000) undergoing anesthesia or intensive care maneuvers at our institution. This registry&#xD;
        aims to assist in carrying out registry-based clinical studies focused on improving current&#xD;
        therapeutic and patient management standards.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study aims to collect data on 300,000 patients who undergo anesthesia and/or&#xD;
        resuscitation procedures at the IRCCS San Raffaele Scientific Institute over a 10 years&#xD;
        period. The information collected will include demographic data, anthropometric data, past&#xD;
        and/or current clinical history of the patient, anamnestic clinical-instrumental data related&#xD;
        to the anesthetic activity, data on therapeutic measures taken during stay in intensive care&#xD;
        units, laboratory parameters, diagnostic tests, therapeutic procedures carried out during&#xD;
        hospitalization, patient satisfaction, and evaluation scales. All this data will be&#xD;
        anonymized prior insertion in the database, with the aim of creating a registry that can be&#xD;
        used for scientific research. This registry aims to assist in carrying out registry-based&#xD;
        clinical studies focused on improving current therapeutic and patient management standards.&#xD;
        The duration of observation of each patient will be variable, depending on the length of&#xD;
        hospital stay and/or the duration of the diagnostic-therapeutic process. The analysis will&#xD;
        follow the clinical course of patients from admission to hospital discharge, with the&#xD;
        possibility of conducting telephone follow-ups for certain categories of patients after 1&#xD;
        year. Statistical analyses will be performed by grouping or describing patients based on&#xD;
        their characteristics or in relation to the type of anesthetic and resuscitation procedures&#xD;
        they undergo.&#xD;
  &#xD;
        This study will follow the ethical principles outlined in the Helsinki Declaration and the&#xD;
        current regulations for Observational Studies. All patients will be fully informed about the&#xD;
        aspects of the study and their written informed consent will be required before&#xD;
        participation.&#xD;
  &#xD;
        Participation in the study is voluntary and free. No additional costs are expected for data&#xD;
        collection and analysis: given the observational nature of the study, insurance coverage is&#xD;
        not required.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2033</completion_date>
    <primary_completion_date type="Anticipated">September 2033</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Clinical outcomes of patients urdergoing anesthesia and/or critical care</measure>
      <time_frame>hospital discharge (usually &lt;=30 days)</time_frame>
      <description>This study will collect data on the anesthesia-related and hospital outcome of patients undergoing anesthesia and intensive care. Due to the large sample size and heterogeneity of populations, further analysis will be planned to address homogenenous subgroups of patients.</description>
    </primary_outcome>
    <enrollment type="Anticipated">30000</enrollment>
    <condition>Anesthesia</condition>
    <condition>Critical Care</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Normal Clinical practice</intervention_name>
      <description>Normal Clinical practice</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Any patients undergoing Anesthesia or critical care -related maneuvers admitted to our&#xD;
          hospital. All patients will follow their normal course of diagnosis/treatment without any&#xD;
          further requirements for the scope of this study other than those provided in the normal&#xD;
          management of patients with this condition. Furthermore, any decision regarding drug or&#xD;
          procedure will be made by the physician based on her/his clinical judgment in the context&#xD;
          of clinical practice, independently from the decision to include the patient in this study.&#xD;
          No follow-up medical and/or imaging examinations/laboratory analysis after hospital&#xD;
          discharge are needed by the present study design.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing Anesthesia or Critical care&#xD;
  &#xD;
            -  Signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Refused 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_contact>
      <last_name>Marina Pieri, MD</last_name>
      <phone>+39022643</phone>
      <phone_ext>6151</phone_ext>
      <email>pieri.marina@hsr.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ospedale San Raffaele di Milano</name>
        <address>
          <city>Milan</city>
          <state>MI</state>
          <zip>20132</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <reference>
      <citation>Lanier WL. A three-decade perspective on anesthesia safety. Am Surg. 2006 Nov;72(11):985-9; discussion 1021-30, 1133-48. doi: 10.1177/000313480607201101.</citation>
      <PMID>17120937</PMID>
    </reference>
    <reference>
      <citation>Desmarais P, Herrmann N, Alam F, Choi S, Avramescu S. Future Directions for Geriatric Anesthesiology. Anesthesiol Clin. 2019 Sep;37(3):581-592. doi: 10.1016/j.anclin.2019.05.002. Epub 2019 Jun 14.</citation>
      <PMID>31337487</PMID>
    </reference>
    <reference>
      <citation>Belletti A, Palumbo D, Zangrillo A, Fominskiy EV, Franchini S, Dell'Acqua A, Marinosci A, Monti G, Vitali G, Colombo S, Guazzarotti G, Lembo R, Maimeri N, Faustini C, Pennella R, Mushtaq J, Landoni G, Scandroglio AM, Dagna L, De Cobelli F; COVID-BioB Study Group. Predictors of Pneumothorax/Pneumomediastinum in Mechanically Ventilated COVID-19 Patients. J Cardiothorac Vasc Anesth. 2021 Dec;35(12):3642-3651. doi: 10.1053/j.jvca.2021.02.008. Epub 2021 Feb 6.</citation>
      <PMID>33678544</PMID>
    </reference>
    <reference>
      <citation>Liau A, Havidich JE, Onega T, Dutton RP. The National Anesthesia Clinical Outcomes Registry. Anesth Analg. 2015 Dec;121(6):1604-10. doi: 10.1213/ANE.0000000000000895.</citation>
      <PMID>26579661</PMID>
    </reference>
    <reference>
      <citation>Shapiro FE, Jani SR, Liu X, Dutton RP, Urman RD. Initial results from the National Anesthesia Clinical Outcomes Registry and overview of office-based anesthesia. Anesthesiol Clin. 2014 Jun;32(2):431-44. doi: 10.1016/j.anclin.2014.02.018.</citation>
      <PMID>24882129</PMID>
    </reference>
    <reference>
      <citation>Beane A, Salluh JIF, Haniffa R. What intensive care registries can teach us about outcomes. Curr Opin Crit Care. 2021 Oct 1;27(5):537-543. doi: 10.1097/MCC.0000000000000865.</citation>
      <PMID>34393177</PMID>
    </reference>
    <reference>
      <citation>Arabi YM, Azoulay E, Al-Dorzi HM, Phua J, Salluh J, Binnie A, Hodgson C, Angus DC, Cecconi M, Du B, Fowler R, Gomersall CD, Horby P, Juffermans NP, Kesecioglu J, Kleinpell RM, Machado FR, Martin GS, Meyfroidt G, Rhodes A, Rowan K, Timsit JF, Vincent JL, Citerio G. How the COVID-19 pandemic will change the future of critical care. Intensive Care Med. 2021 Mar;47(3):282-291. doi: 10.1007/s00134-021-06352-y. Epub 2021 Feb 22.</citation>
      <PMID>33616696</PMID>
    </reference>
    <reference>
      <citation>James A, De Jong A, Jeanmougin T, Blanie A, Figueiredo S, Goffin P, Le Guen M, Kantor E, Cipriani F, Campion S, Raux M, Jaber S, Futier E, Constantin JM; Societe Francaise d'Anesthesie Reanimation (SFAR) Research Network. Characteristics and outcomes of patients undergoing anesthesia while SARS-CoV-2 infected or suspected: a multicenter register of consecutive patients. BMC Anesthesiol. 2022 Feb 14;22(1):46. doi: 10.1186/s12871-022-01581-0.</citation>
      <PMID>35164679</PMID>
    </reference>
    <reference>
      <citation>Monaco F, Belletti A, Bove T, Landoni G, Zangrillo A. Extracorporeal Membrane Oxygenation: Beyond Cardiac Surgery and Intensive Care Unit: Unconventional Uses and Future Perspectives. J Cardiothorac Vasc Anesth. 2018 Aug;32(4):1955-1970. doi: 10.1053/j.jvca.2018.03.031. Epub 2018 Mar 20.</citation>
      <PMID>29709436</PMID>
    </reference>
    <reference>
      <citation>Kelly FE, Fong K, Hirsch N, Nolan JP. Intensive care medicine is 60 years old: the history and future of the intensive care unit. Clin Med (Lond). 2014 Aug;14(4):376-9. doi: 10.7861/clinmedicine.14-4-376.</citation>
      <PMID>25099838</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 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 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Università Vita-Salute San Raffaele</investigator_affiliation>
      <investigator_full_name>Giovanni Landoni</investigator_full_name>
      <investigator_title>MD, Full Professor</investigator_title>
    </responsible_party>
    <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/NCT06033404
  org study id: ARIA - 40/INT//2023
  nct id: NCT06033404
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In recent decades, knowledge in the anesthesiology field has increasingly expanded, allowing
        for the refinement of monitoring techniques, therapies, and local-regional anesthesia
        maneuvers, and for the extension of care to a larger number of patients, including those
        previously excluded due to advanced age or comorbidities. Similarly, Intensive care
        management has continuously evolved, following innovations in the field of drugs and with the
        great diffusion of extracorporeal supports. The fundamental importance of registry studies
        has been recognized in this context to rapidly generate reliable data and improve the quality
        of care.
  
        This prospective observational study is aimed at collecting data of all patients (expected
        300,000) undergoing anesthesia or intensive care maneuvers at our institution. This registry
        aims to assist in carrying out registry-based clinical studies focused on improving current
        therapeutic and patient management standards.
  The study aims to collect data on 300,000 patients who undergo anesthesia and/or
        resuscitation procedures at the IRCCS San Raffaele Scientific Institute over a 10 years
        period. The information collected will include demographic data, anthropometric data, past
        and/or current clinical history of the patient, anamnestic clinical-instrumental data related
        to the anesthetic activity, data on therapeutic measures taken during stay in intensive care
        units, laboratory parameters, diagnostic tests, therapeutic procedures carried out during
        hospitalization, patient satisfaction, and evaluation scales. All this data will be
        anonymized prior insertion in the database, with the aim of creating a registry that can be
        used for scientific research. This registry aims to assist in carrying out registry-based
        clinical studies focused on improving current therapeutic and patient management standards.
        The duration of observation of each patient will be variable, depending on the length of
        hospital stay and/or the duration of the diagnostic-therapeutic process. The analysis will
        follow the clinical course of patients from admission to hospital discharge, with the
        possibility of conducting telephone follow-ups for certain categories of patients after 1
        year. Statistical analyses will be performed by grouping or describing patients based on
        their characteristics or in relation to the type of anesthetic and resuscitation procedures
        they undergo.
  
        This study will follow the ethical principles outlined in the Helsinki Declaration and the
        current regulations for Observational Studies. All patients will be fully informed about the
        aspects of the study and their written informed consent will be required before
        participation.
  
        Participation in the study is voluntary and free. No additional costs are expected for data
        collection and analysis: given the observational nature of the study, insurance coverage is
        not required.
  observational model: Cohort
  time perspective: Prospective
  measure: Clinical outcomes of patients urdergoing anesthesia and/or critical care
  time frame: hospital discharge (usually <=30 days)
  description: This study will collect data on the anesthesia-related and hospital outcome of patients undergoing anesthesia and intensive care. Due to the large sample size and heterogeneity of populations, further analysis will be planned to address homogenenous subgroups of patients.
  intervention type: Procedure
  intervention name: Normal Clinical practice
  description: Normal Clinical practice
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marina Pieri, MD
  phone: +39022643
  phone ext: 6151
  email: pieri.marina@hsr.it
  facility: 
  country: Italy
  citation: Lanier WL. A three-decade perspective on anesthesia safety. Am Surg. 2006 Nov;72(11):985-9; discussion 1021-30, 1133-48. doi: 10.1177/000313480607201101.
  PMID: 17120937
  citation: Desmarais P, Herrmann N, Alam F, Choi S, Avramescu S. Future Directions for Geriatric Anesthesiology. Anesthesiol Clin. 2019 Sep;37(3):581-592. doi: 10.1016/j.anclin.2019.05.002. Epub 2019 Jun 14.
  PMID: 31337487
  citation: Belletti A, Palumbo D, Zangrillo A, Fominskiy EV, Franchini S, Dell'Acqua A, Marinosci A, Monti G, Vitali G, Colombo S, Guazzarotti G, Lembo R, Maimeri N, Faustini C, Pennella R, Mushtaq J, Landoni G, Scandroglio AM, Dagna L, De Cobelli F; COVID-BioB Study Group. Predictors of Pneumothorax/Pneumomediastinum in Mechanically Ventilated COVID-19 Patients. J Cardiothorac Vasc Anesth. 2021 Dec;35(12):3642-3651. doi: 10.1053/j.jvca.2021.02.008. Epub 2021 Feb 6.
  PMID: 33678544
  citation: Liau A, Havidich JE, Onega T, Dutton RP. The National Anesthesia Clinical Outcomes Registry. Anesth Analg. 2015 Dec;121(6):1604-10. doi: 10.1213/ANE.0000000000000895.
  PMID: 26579661
  citation: Shapiro FE, Jani SR, Liu X, Dutton RP, Urman RD. Initial results from the National Anesthesia Clinical Outcomes Registry and overview of office-based anesthesia. Anesthesiol Clin. 2014 Jun;32(2):431-44. doi: 10.1016/j.anclin.2014.02.018.
  PMID: 24882129
  citation: Beane A, Salluh JIF, Haniffa R. What intensive care registries can teach us about outcomes. Curr Opin Crit Care. 2021 Oct 1;27(5):537-543. doi: 10.1097/MCC.0000000000000865.
  PMID: 34393177
  citation: Arabi YM, Azoulay E, Al-Dorzi HM, Phua J, Salluh J, Binnie A, Hodgson C, Angus DC, Cecconi M, Du B, Fowler R, Gomersall CD, Horby P, Juffermans NP, Kesecioglu J, Kleinpell RM, Machado FR, Martin GS, Meyfroidt G, Rhodes A, Rowan K, Timsit JF, Vincent JL, Citerio G. How the COVID-19 pandemic will change the future of critical care. Intensive Care Med. 2021 Mar;47(3):282-291. doi: 10.1007/s00134-021-06352-y. Epub 2021 Feb 22.
  PMID: 33616696
  citation: James A, De Jong A, Jeanmougin T, Blanie A, Figueiredo S, Goffin P, Le Guen M, Kantor E, Cipriani F, Campion S, Raux M, Jaber S, Futier E, Constantin JM; Societe Francaise d'Anesthesie Reanimation (SFAR) Research Network. Characteristics and outcomes of patients undergoing anesthesia while SARS-CoV-2 infected or suspected: a multicenter register of consecutive patients. BMC Anesthesiol. 2022 Feb 14;22(1):46. doi: 10.1186/s12871-022-01581-0.
  PMID: 35164679
  citation: Monaco F, Belletti A, Bove T, Landoni G, Zangrillo A. Extracorporeal Membrane Oxygenation: Beyond Cardiac Surgery and Intensive Care Unit: Unconventional Uses and Future Perspectives. J Cardiothorac Vasc Anesth. 2018 Aug;32(4):1955-1970. doi: 10.1053/j.jvca.2018.03.031. Epub 2018 Mar 20.
  PMID: 29709436
  citation: Kelly FE, Fong K, Hirsch N, Nolan JP. Intensive care medicine is 60 years old: the history and future of the intensive care unit. Clin Med (Lond). 2014 Aug;14(4):376-9. doi: 10.7861/clinmedicine.14-4-376.
  PMID: 25099838
  responsible party type: Principal Investigator
  investigator affiliation: Università Vita-Salute San Raffaele
  investigator full name: Giovanni Landoni
  investigator title: MD, Full Professor
  sharing ipd: No