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/NCT06033235</url>
    </required_header>
    <id_info>
      <org_study_id>0220-23-MMC</org_study_id>
      <nct_id>NCT06033235</nct_id>
    </id_info>
    <brief_title>Computed Tomography Scanning in ICU</brief_title>
    <official_title>Impact of Computed Tomography Scanning on ICU Patient Management: Retrospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Meir Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Meir Medical Center</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>
        Patients admitted to the intensive care unit often require CT imaging. Performing this&#xD;
        diagnostic test on a critically ill patient involves risks, such as those associated with&#xD;
        transferring a ventilated and unstable patient and those associated with the injection of&#xD;
        intravenous contrast material. Also, multiple CT examinations may create a burden on the&#xD;
        X-ray institute and the medical staff, result in the postponement of CT examinations for&#xD;
        other patients, as well as increase hospitalization costs.&#xD;
  &#xD;
        In this work, we would like to check the rate of complications involved in performing a CT&#xD;
        scan in patients hospitalized in the general intensive care unit of our institution, while&#xD;
        analyzing the differences between the times the test is performed (morning, night shift), as&#xD;
        well as examine in what percentage of the CT scans the test performed contributed to a&#xD;
        significant progress in the diagnosis or a significant change in the treatment plan of the&#xD;
        patient, while referring to subgroups (sepsis, trauma, respiratory failure, with an emphasis&#xD;
        on covid patients, patients with scoliosis, patients with intracranial pathology).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change in diagnosis and/or patient management</measure>
      <time_frame>3 years</time_frame>
      <description>To examine in what percentage of the CT examinations the examination contributed to a significant progress in the diagnosis or a significant change in the patient's treatment plan, while referring to subgroups of patients in the intensive care unit.</description>
    </primary_outcome>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>CT Scans in the Intensive Care Unit</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>CT scan in critically ill patients in the intensive care unit</intervention_name>
      <description>CT scan in critically ill patients in the intensive care unit</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients who underwent CT examinations during hospitalization in the intensive care unit&#xD;
          for any etiology, from January 2020 to January 2023.&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:All patients who underwent CT examinations during hospitalization in the&#xD;
          intensive care unit for any etiology, from January 2020 to January 2023.&#xD;
  &#xD;
          -&#xD;
  &#xD;
          Exclusion Criteria:Patients who did not meet the above criteria or for whom data were&#xD;
          missing.&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Meir Medical Center</name>
        <address>
          <city>Kfar Saba</city>
          <country>Israel</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 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>Meir Medical Center</investigator_affiliation>
      <investigator_full_name>sara dichtwald</investigator_full_name>
      <investigator_title>Dr</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/NCT06033235
  org study id: 0220-23-MMC
  nct id: NCT06033235
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Patients admitted to the intensive care unit often require CT imaging. Performing this
        diagnostic test on a critically ill patient involves risks, such as those associated with
        transferring a ventilated and unstable patient and those associated with the injection of
        intravenous contrast material. Also, multiple CT examinations may create a burden on the
        X-ray institute and the medical staff, result in the postponement of CT examinations for
        other patients, as well as increase hospitalization costs.
  
        In this work, we would like to check the rate of complications involved in performing a CT
        scan in patients hospitalized in the general intensive care unit of our institution, while
        analyzing the differences between the times the test is performed (morning, night shift), as
        well as examine in what percentage of the CT scans the test performed contributed to a
        significant progress in the diagnosis or a significant change in the treatment plan of the
        patient, while referring to subgroups (sepsis, trauma, respiratory failure, with an emphasis
        on covid patients, patients with scoliosis, patients with intracranial pathology).
  observational model: Case-Only
  time perspective: Retrospective
  measure: Change in diagnosis and/or patient management
  time frame: 3 years
  description: To examine in what percentage of the CT examinations the examination contributed to a significant progress in the diagnosis or a significant change in the patient's treatment plan, while referring to subgroups of patients in the intensive care unit.
  intervention type: Diagnostic Test
  intervention name: CT scan in critically ill patients in the intensive care unit
  description: CT scan in critically ill patients in the intensive care unit
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  facility: 
  country: Israel
  responsible party type: Principal Investigator
  investigator affiliation: Meir Medical Center
  investigator full name: sara dichtwald
  investigator title: Dr
  sharing ipd: No