<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/NCT03292627</url>
  </required_header>
  <id_info>
    <org_study_id>201612030RINA</org_study_id>
    <nct_id>NCT03292627</nct_id>
  </id_info>
  <brief_title>Non-invasive Monitor in Endoscopic Invasive Procedure</brief_title>
  <official_title>Applying Non-invasive Hemodynamic Monitor to Predict the Risk of Perioperative Hypotension in Geriatric Patients Underwent Endoscopic Invasive Procedure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University 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>
      Investigators include the patients who need painless invasive endoscopic procedure,&#xD;
      investigators collect the demographic data and apply the non-invasive device ICON on&#xD;
      participants during the who procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Invasive endoscopy procedure including Endoscopic Retrograde Cholangio-Pancreatography&#xD;
      (ERCP), endoscopic ultrasound guided fine needle aspiration (EUS-FNA), Endoscopic Retrograde&#xD;
      Biliary Drainage (ERBD) and others is more and more popular which become the standard&#xD;
      treatment before surgical intervention. However; the elder group who need this procedure is&#xD;
      getting more common. The painless endoscopic sedation for elder group who has more&#xD;
      comorbidity is not easy. During the procedure, the investigators found that the&#xD;
      anticholinergic medication-buscopam which in order to suppress intestine mobilization can&#xD;
      cause obvious tachycardia. Tachycardia makes the stroke volume decrease which enhance the&#xD;
      perioperative hypotension, and the vasodilation effect of the analgesics make it worse.&#xD;
&#xD;
      Investigators are trying to find the non-invasive predictor of perioperative hypotension in&#xD;
      geriatric group. Investigators collected the patients who need painless endoscopic invasive&#xD;
      procedure, investigators will record their hemodynamic data including estimated cardiac&#xD;
      output (CCO)，index of contractility (ICON)，NBP，HR，and saturation. Investigators also add the&#xD;
      evaluation of frailty to evaluate the relationship between frailty and perioperative&#xD;
      complications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ICON decrease 40%</measure>
    <time_frame>during the painless procedure</time_frame>
    <description>estimated index of contractility decrease 40%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>perioperative hypotension 40%</measure>
    <time_frame>during the painless procedure</time_frame>
    <description>BP decrease 40%</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Cholangiopancreatography, Endoscopic Retrograde</condition>
  <condition>Endoscopic Ultrasonography</condition>
  <arm_group>
    <arm_group_label>mid age</arm_group_label>
    <description>mid age: 50-70 years old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>old age</arm_group_label>
    <description>old age: age older than 70 years old</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Portable Noninvasive Hemodynamic Monitor</intervention_name>
    <description>A non-invasive monitor for estimating patient's heart contractility and cardiac output by the change of thoracic electrical bioimpedance.</description>
    <arm_group_label>mid age</arm_group_label>
    <arm_group_label>old age</arm_group_label>
    <other_name>The ICON™ monitor</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Investigators are trying to find the non-invasive predictor of perioperative hypotension in&#xD;
        geriatric group. Investigator collected the patients who need painless endoscopic invasive&#xD;
        procedure, investigator record their hemodynamic data including estimated cardiac output&#xD;
        (CCO)，index of contractility (ICON)，NBP，HR，and saturation. Investigator wants to find that&#xD;
        weather geriatric group has more risk of perioperative hypotension.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient who need painless endoscopic invasive procedures&#xD;
&#xD;
          -  age above 50 y/o&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hsiu-po Wang, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03292627
org study id: 201612030RINA
nct id: NCT03292627
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Investigators include the patients who need painless invasive endoscopic procedure,
      investigators collect the demographic data and apply the non-invasive device ICON on
      participants during the who procedure.
Invasive endoscopy procedure including Endoscopic Retrograde Cholangio-Pancreatography
      (ERCP), endoscopic ultrasound guided fine needle aspiration (EUS-FNA), Endoscopic Retrograde
      Biliary Drainage (ERBD) and others is more and more popular which become the standard
      treatment before surgical intervention. However; the elder group who need this procedure is
      getting more common. The painless endoscopic sedation for elder group who has more
      comorbidity is not easy. During the procedure, the investigators found that the
      anticholinergic medication-buscopam which in order to suppress intestine mobilization can
      cause obvious tachycardia. Tachycardia makes the stroke volume decrease which enhance the
      perioperative hypotension, and the vasodilation effect of the analgesics make it worse.

      Investigators are trying to find the non-invasive predictor of perioperative hypotension in
      geriatric group. Investigators collected the patients who need painless endoscopic invasive
      procedure, investigators will record their hemodynamic data including estimated cardiac
      output (CCO)，index of contractility (ICON)，NBP，HR，and saturation. Investigators also add the
      evaluation of frailty to evaluate the relationship between frailty and perioperative
      complications.
observational model: Case-Control
time perspective: Prospective
measure: ICON decrease 40%
time frame: during the painless procedure
description: estimated index of contractility decrease 40%
measure: perioperative hypotension 40%
time frame: during the painless procedure
description: BP decrease 40%
arm group label: mid age
description: mid age: 50-70 years old
arm group label: old age
description: old age: age older than 70 years old
intervention type: Device
intervention name: Portable Noninvasive Hemodynamic Monitor
description: A non-invasive monitor for estimating patient's heart contractility and cardiac output by the change of thoracic electrical bioimpedance.
arm group label: mid age
arm group label: old age
other name: The ICON™ monitor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Hsiu-po Wang, M.D., Ph.D.
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor