<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/NCT02993497</url>
  </required_header>
  <id_info>
    <org_study_id>1-2016-0063</org_study_id>
    <nct_id>NCT02993497</nct_id>
  </id_info>
  <brief_title>Respiratory Measurement Using Infrared Camera and Respiratory Volume Monitor (ExSpiron 1Xi) for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia</brief_title>
  <official_title>Respiratory Measurement Using Infrared Camera and Respiratory Volume Monitor (ExSpiron 1Xi) for Sedation in Patients Undergoing TURP/TURB Under Spinal Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</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 patients undergoing spinal anesthesia, the investigators used an Infra-red camera and a&#xD;
      respiratory volume monitor to determine the accuracy of the ventilation rate of the infra red&#xD;
      camera by measuring the respiratory rate, ventilation volume, and ventilation volume with&#xD;
      respiratory volume monitor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2017</start_date>
  <completion_date type="Actual">July 4, 2017</completion_date>
  <primary_completion_date type="Actual">July 4, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The accuracy of breathing measurements</measure>
    <time_frame>Intraoperative period about 1 hour</time_frame>
    <description>The accuracy of breathing measurements between infrared camera and RVM in patients with spinal anesthesia</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Bladder Cancer</condition>
  <arm_group>
    <arm_group_label>Respiratory monitoring group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Infrared camera</intervention_name>
    <description>In patients undergoing spinal anesthesia, the respiratory parameters are measured using an Infrared camera.</description>
    <arm_group_label>Respiratory monitoring group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RVM(Respiratory Volume Monitor)</intervention_name>
    <description>In patients undergoing spinal anesthesia, the respiratory parameters are measured using an RVM(Respiratory Volume Monitor).</description>
    <arm_group_label>Respiratory monitoring group</arm_group_label>
    <other_name>ExSpiron™ 1Xi</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An adult male who underwent endoscopic prostatectomy resection with regular surgery&#xD;
&#xD;
          -  An adult male who underwent endoscopic bladder resection with regular surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presenting alteration in respiratory function detected by functional analysis of lung&#xD;
             volume and capacity- pneumonectomy patient, severe ipsilateral destroyed lung patient&#xD;
&#xD;
          -  Inability to understand or perform the procedure&#xD;
&#xD;
          -  ASA(American Society of Anesthesiologists) class 4,5&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>November 9, 2017</last_update_submitted>
  <last_update_submitted_qc>November 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02993497
org study id: 1-2016-0063
nct id: NCT02993497
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In patients undergoing spinal anesthesia, the investigators used an Infra-red camera and a
      respiratory volume monitor to determine the accuracy of the ventilation rate of the infra red
      camera by measuring the respiratory rate, ventilation volume, and ventilation volume with
      respiratory volume monitor.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The accuracy of breathing measurements
time frame: Intraoperative period about 1 hour
description: The accuracy of breathing measurements between infrared camera and RVM in patients with spinal anesthesia
arm group label: Respiratory monitoring group
arm group type: Experimental
intervention type: Device
intervention name: Infrared camera
description: In patients undergoing spinal anesthesia, the respiratory parameters are measured using an Infrared camera.
arm group label: Respiratory monitoring group
intervention type: Device
intervention name: RVM(Respiratory Volume Monitor)
description: In patients undergoing spinal anesthesia, the respiratory parameters are measured using an RVM(Respiratory Volume Monitor).
arm group label: Respiratory monitoring group
other name: ExSpiron™ 1Xi
criteria: 
gender: Male
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Urinary Bladder Neoplasms
sharing ipd: Undecided