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/NCT06003517</url>
    </required_header>
    <id_info>
      <org_study_id>K3120</org_study_id>
      <nct_id>NCT06003517</nct_id>
    </id_info>
    <brief_title>Retrospective Study on Perioperative Safety and Quality Control Based on Real World Data</brief_title>
    <official_title>Retrospective Study on Perioperative Safety and Quality Control Based on Real World Data</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Based on the data from the anesthesia record electronic system, patient safety incident (PSI)&#xD;
        electronic reporting system and related PSI retrospective cohort in the past 10 years, this&#xD;
        project intends to carry out structured and consistent (real world data)RWD processing, and&#xD;
        conduct (real world evidence)RWE research related to perioperative safety and quality control&#xD;
        in order to characterize the epidemiology of perioperative PSIs, explore the related factors,&#xD;
        and construct a prediction model, and on the basis of which to construct a standardized&#xD;
        platform for reporting and analysis of perioperative PSIs based on RWD. On this basis, a&#xD;
        standardized platform for PSI reporting and analysis was constructed based on RWD.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 10, 2022</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Occurrence of PSI</measure>
      <time_frame>Perioperative period, from the beginning of the surgery to 7 days after the surgery.</time_frame>
      <description>Occurrence of patient safety incident, including post extubation tracheal intubation, intraoperative cardiac arrest, allergic reactions.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">3000</enrollment>
    <condition>Perioperative Complication</condition>
    <arm_group>
      <arm_group_label>Patients with perioperative safety events</arm_group_label>
      <description>Patients with perioperative safety events, including post extubation tracheal intubation, intraoperative cardiac arrest, allergic reactions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients without perioperative safety events</arm_group_label>
      <description>Patients without perioperative safety events, including post extubation tracheal intubation, intraoperative cardiac arrest, allergic reactions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Screening with PSI check list</intervention_name>
      <description>Screening PSI with institutional check list</description>
      <arm_group_label>Patients with perioperative safety events</arm_group_label>
      <arm_group_label>Patients without perioperative safety events</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Perioperative patients with anesthesia electronic records that can analysis the patient&#xD;
          safety incident.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  perioperative patients with anesthesia electronic records.&#xD;
  &#xD;
            -  aged more than 18 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  data incomplete&#xD;
  &#xD;
            -  data missing&#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>Yuan Tian, MD</last_name>
      <phone>8618810261573</phone>
      <email>counsissis@sina.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Anesthesiology, Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yuan Tian, MD</last_name>
        <phone>+86 18810261573</phone>
        <email>counsissis@sina.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06003517
  org study id: K3120
  nct id: NCT06003517
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Based on the data from the anesthesia record electronic system, patient safety incident (PSI)
        electronic reporting system and related PSI retrospective cohort in the past 10 years, this
        project intends to carry out structured and consistent (real world data)RWD processing, and
        conduct (real world evidence)RWE research related to perioperative safety and quality control
        in order to characterize the epidemiology of perioperative PSIs, explore the related factors,
        and construct a prediction model, and on the basis of which to construct a standardized
        platform for reporting and analysis of perioperative PSIs based on RWD. On this basis, a
        standardized platform for PSI reporting and analysis was constructed based on RWD.
  observational model: Case-Control
  time perspective: Retrospective
  measure: Occurrence of PSI
  time frame: Perioperative period, from the beginning of the surgery to 7 days after the surgery.
  description: Occurrence of patient safety incident, including post extubation tracheal intubation, intraoperative cardiac arrest, allergic reactions.
  arm group label: Patients with perioperative safety events
  description: Patients with perioperative safety events, including post extubation tracheal intubation, intraoperative cardiac arrest, allergic reactions.
  arm group label: Patients without perioperative safety events
  description: Patients without perioperative safety events, including post extubation tracheal intubation, intraoperative cardiac arrest, allergic reactions.
  intervention type: Procedure
  intervention name: Screening with PSI check list
  description: Screening PSI with institutional check list
  arm group label: Patients with perioperative safety events
  arm group label: Patients without perioperative safety events
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Yuan Tian, MD
  phone: 8618810261573
  email: counsissis@sina.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  sharing ipd: Undecided