<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/NCT02998294</url>
  </required_header>
  <id_info>
    <org_study_id>1-2016-0008</org_study_id>
    <nct_id>NCT02998294</nct_id>
  </id_info>
  <brief_title>Respiratory Volume Measure Using ExSpiron 1Xi</brief_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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to determine the accuracy of one-time respiratory volume&#xD;
      measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume&#xD;
      measured by mechanical ventilation in post-operative ICU patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study was to determine the accuracy of one-time respiratory volume&#xD;
      measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume&#xD;
      measured by mechanical ventilation in post-operative ICU patients.&#xD;
&#xD;
      In addition, the investigators investigated the decrease in respiratory volume in opioid&#xD;
      infusion after ventilator weaning in this patient, and to measure the one-time respiratory&#xD;
      volume change by RVM during deep breathing induction using Inspirometry exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 6, 2016</start_date>
  <completion_date type="Actual">February 15, 2017</completion_date>
  <primary_completion_date type="Actual">February 15, 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>Respiratory volume measure using ExSpiron 1Xi</measure>
    <time_frame>during 10-minute</time_frame>
    <description>During mechanical ventilator, we obtained respiratory parameter from ventilator and also we collected same parameter via RVM.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>ICU(Intensive Care Unit) Patients</condition>
  <condition>Mechanical Ventilation After Surgery</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>Respiratory Volume Monitor(RVM)</intervention_name>
    <description>The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.</description>
    <arm_group_label>Respiratory monitoring group</arm_group_label>
    <other_name>ExSpiron™ 1Xi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>artificial respirator</intervention_name>
    <description>The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.</description>
    <arm_group_label>Respiratory monitoring group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An adult patients ( ≥ age 19)&#xD;
&#xD;
          -  patients who receive mechanical ventilation in the ICU of the Severance Hospital after&#xD;
             surgery and plans to wean the mechanical ventilation within 3 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe respiratory illness patients (pneumothorax, chest tube intubation status,&#xD;
             severe restrictive respiratory disease, unilateral lung ventilation, lung&#xD;
             transplantation status, chronic restrictive respiratory disease, hydrothorax,&#xD;
             diaphragmatic movement disorder)&#xD;
&#xD;
          -  If the candidate can not understand and carry out the experiment contents and process&#xD;
      </textblock>
    </criteria>
    <gender>All</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>July 2018</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>July 15, 2018</last_update_submitted>
  <last_update_submitted_qc>July 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2018</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>


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/NCT02998294
org study id: 1-2016-0008
nct id: NCT02998294
lead sponsor: 
has dmc: No
The purpose of this study was to determine the accuracy of one-time respiratory volume
      measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume
      measured by mechanical ventilation in post-operative ICU patients.
The purpose of this study was to determine the accuracy of one-time respiratory volume
      measured by RVM(Respiratory Volume Monitor) compared to the one-time respiratory volume
      measured by mechanical ventilation in post-operative ICU patients.

      In addition, the investigators investigated the decrease in respiratory volume in opioid
      infusion after ventilator weaning in this patient, and to measure the one-time respiratory
      volume change by RVM during deep breathing induction using Inspirometry exercise.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Respiratory volume measure using ExSpiron 1Xi
time frame: during 10-minute
description: During mechanical ventilator, we obtained respiratory parameter from ventilator and also we collected same parameter via RVM.
arm group label: Respiratory monitoring group
arm group type: Experimental
intervention type: Device
intervention name: Respiratory Volume Monitor(RVM)
description: The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.
arm group label: Respiratory monitoring group
other name: ExSpiron™ 1Xi
intervention type: Device
intervention name: artificial respirator
description: The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.
arm group label: Respiratory monitoring group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
sharing ipd: Undecided