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/NCT05991063</url>
    </required_header>
    <id_info>
      <org_study_id>Ms2022</org_study_id>
      <nct_id>NCT05991063</nct_id>
    </id_info>
    <brief_title>The Ability Of Inferior Vena Caval Distensibility Index With Passive Leg Raising Test To Predict Spinal Anesthesia-induced Hypotension In Elderly Patients Undergoing Infra-umbilical Surgeries. A Prospective Observational Study.</brief_title>
    <official_title>The Ability Of Inferior Vena Caval Distensibility Index With Passive Leg Raising Test To Predict Spinal Anesthesia-induced Hypotension In Elderly Patients Undergoing Infra-umbilical Surgeries. A Prospective Observational Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</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>
        Many previous studies have investigated the ability of various methods such as passive leg&#xD;
        raising test , and inferior vena cava collapsibility index in predicting post-spinal&#xD;
        hypotension, but none of them have succeeded in obtaining a good predictive value.&#xD;
  &#xD;
        Our study aims to combine the passive leg raising test with the inferior vena cava&#xD;
        distensibility index to aid in predicting post-spinal hypotension in elderly undergoing&#xD;
        infra-umbilical surgeries.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>The sensitivity of Δmax.IVCd in predicting post-spinal anesthesia hypotension in elderly patients.</measure>
      <time_frame>15 minutes before spinal anesthesia</time_frame>
      <description>The incremental changes of measured maximum inferior vena caval diameter after passive leg raising</description>
    </primary_outcome>
    <enrollment type="Anticipated">68</enrollment>
    <condition>Spinal Anesthetics Causing Adverse Effects in Therapeutic Use</condition>
    <eligibility>
      <study_pop>
        <textblock>
          A total of 68 consecutive elderly patients, aged &gt;65 years scheduled for elective&#xD;
          infra-umbilical surgical operations under spinal anesthesia will be included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. 65 years of age or more. 2. ASA score I &amp; II. 3. Patients are scheduled for infra&#xD;
               umbilical surgeries under spinal anesthesia.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Negative consent. Pre-existing hypertension Diabetes mellitus or autonomic neuropathy&#xD;
               (patients diagnosed with autonomic neuropathy or having suggestive symptoms such as&#xD;
               orthostatic hypotension, syncopal attacks, decreased sweating, and urinary&#xD;
               incontinence) Emergency operations Absolute contraindications or failure to perform&#xD;
               spinal anesthesia If PLR maneuver is contraindicated (intracranial hypertension) or&#xD;
               possibly unreliable ( venous compression stocking, intraabdominal hypertension)&#xD;
               Difficulties in IVC visualization due to increased subcutaneous fat tissue or gastric&#xD;
               gas interferin&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>mohamed abdelghany ali</investigator_full_name>
      <investigator_title>Lecturer of anesthesia</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypotension</mesh_term>
    </condition_browse>
    <!-- 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/NCT05991063
  org study id: Ms2022
  nct id: NCT05991063
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Many previous studies have investigated the ability of various methods such as passive leg
        raising test , and inferior vena cava collapsibility index in predicting post-spinal
        hypotension, but none of them have succeeded in obtaining a good predictive value.
  
        Our study aims to combine the passive leg raising test with the inferior vena cava
        distensibility index to aid in predicting post-spinal hypotension in elderly undergoing
        infra-umbilical surgeries.
  observational model: Cohort
  time perspective: Prospective
  measure: The sensitivity of Δmax.IVCd in predicting post-spinal anesthesia hypotension in elderly patients.
  time frame: 15 minutes before spinal anesthesia
  description: The incremental changes of measured maximum inferior vena caval diameter after passive leg raising
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: mohamed abdelghany ali
  investigator title: Lecturer of anesthesia
  mesh term: Hypotension