<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/NCT03791437</url>
  </required_header>
  <id_info>
    <org_study_id>CGMH-IRB-201701495A3</org_study_id>
    <nct_id>NCT03791437</nct_id>
  </id_info>
  <brief_title>Optimization of Chest Tube Drainage Management</brief_title>
  <official_title>Optimization of Chest Tube Drainage Management to Shorten Postoperative Hospital Stay and Increase Satisfaction of Patients After Video-Assisted Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Early recovery after surgery was new developing science in recent years. However , there was&#xD;
      few reports in thoracic surgery field . Investigators try to using digital chest drainage&#xD;
      management system into the field of postoperative care and to see whether it could help&#xD;
      patients to recovery from surgery as soon as possible. According to investigators's clinical&#xD;
      data collecting , investigators will establish a new postoperative care guideline for those&#xD;
      patients who receive thoracic surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Drainage of the space between the ribs and lungs has been practiced since the time of&#xD;
      Hippocrates. Thus far, the function of chest tubes, specifically to drain fluid or air from&#xD;
      the pleural space, has virtually remained unchanged for more than 3000 years. The use of&#xD;
      chest drainage tubes after thoracic surgery is crucial to evacuate air leakage and/or pleural&#xD;
      effusion; however, delayed tube removal may exacerbate pain, delay recovery of lung function&#xD;
      and prolong hospitalization. Recently, Thopaz digitally monitored thoracic drainage system&#xD;
      (Medela Healthcare, Baar, Switzerland)has been designed to provide objective measurements of&#xD;
      air leakage and pleural pressure. With this system, air leakage and pleural pressure can be&#xD;
      accurately measured in mL/min and mm H2O, respectively. The rate of air leakage can be seen&#xD;
      on a display in real time. Digital surveillance for air leakage is reported to reduce&#xD;
      interobserver disagreement in decision making in the management of patients with chest tubes,&#xD;
      which might help caregiver a more solid evidence of strategies of postoperative chest&#xD;
      drainage care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>digital chest drainage system</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Air leak graph of digital drainage system</measure>
    <time_frame>Follow patient 's condition in OPD post surgery in two years</time_frame>
    <description>Compare Digital chest drainage system with traditional drainage system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Days of hospital stay after surgery</measure>
    <time_frame>Follow patient 's condition in OPD post surgery in two years</time_frame>
    <description>Compare Digital chest drainage system with traditional drainage system</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fluid graph of digital drainage system</measure>
    <time_frame>Follow patient 's condition in OPD post surgery in two years</time_frame>
    <description>Compare Digital chest drainage system with traditional drainage system</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">366</enrollment>
  <condition>Lung Diseases</condition>
  <condition>Age &gt;18 Years-old</condition>
  <condition>Patient Who Received Thoracoscope Surgery</condition>
  <arm_group>
    <arm_group_label>Experiment groups</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Post chest operative use Digital chest drainage system until Patient's discharge day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control groups</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Post chest operative use traditional drainage system until Patient's discharge day Not use Digital chest drainage system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Digital chest drainage system</intervention_name>
    <description>patients who received Digital chest drainage system</description>
    <arm_group_label>Experiment groups</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Not use Digital chest drainage system</intervention_name>
    <description>patients who not received Digital chest drainage system( traditional drainage system)</description>
    <arm_group_label>Control groups</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Volunteer to join the study after thoroughly explanations&#xD;
&#xD;
          -  Patient who received thoracoscope surgery for lung lesion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not willing to join the study after thoroughly explanations&#xD;
&#xD;
          -  Patients who have not received thoracoscope surgery for lung lesion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ching-Feng Wu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>digital chest tube system, shorten hospital stay</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03791437
org study id: CGMH-IRB-201701495A3
nct id: NCT03791437
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Early recovery after surgery was new developing science in recent years. However , there was
      few reports in thoracic surgery field . Investigators try to using digital chest drainage
      management system into the field of postoperative care and to see whether it could help
      patients to recovery from surgery as soon as possible. According to investigators's clinical
      data collecting , investigators will establish a new postoperative care guideline for those
      patients who receive thoracic surgery
Drainage of the space between the ribs and lungs has been practiced since the time of
      Hippocrates. Thus far, the function of chest tubes, specifically to drain fluid or air from
      the pleural space, has virtually remained unchanged for more than 3000 years. The use of
      chest drainage tubes after thoracic surgery is crucial to evacuate air leakage and/or pleural
      effusion; however, delayed tube removal may exacerbate pain, delay recovery of lung function
      and prolong hospitalization. Recently, Thopaz digitally monitored thoracic drainage system
      (Medela Healthcare, Baar, Switzerland)has been designed to provide objective measurements of
      air leakage and pleural pressure. With this system, air leakage and pleural pressure can be
      accurately measured in mL/min and mm H2O, respectively. The rate of air leakage can be seen
      on a display in real time. Digital surveillance for air leakage is reported to reduce
      interobserver disagreement in decision making in the management of patients with chest tubes,
      which might help caregiver a more solid evidence of strategies of postoperative chest
      drainage care.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: digital chest drainage system
primary purpose: Other
masking: None (Open Label)
measure: Air leak graph of digital drainage system
time frame: Follow patient 's condition in OPD post surgery in two years
description: Compare Digital chest drainage system with traditional drainage system
measure: Days of hospital stay after surgery
time frame: Follow patient 's condition in OPD post surgery in two years
description: Compare Digital chest drainage system with traditional drainage system
measure: Fluid graph of digital drainage system
time frame: Follow patient 's condition in OPD post surgery in two years
description: Compare Digital chest drainage system with traditional drainage system
arm group label: Experiment groups
arm group type: Experimental
description: Post chest operative use Digital chest drainage system until Patient's discharge day
arm group label: Control groups
arm group type: Active Comparator
description: Post chest operative use traditional drainage system until Patient's discharge day Not use Digital chest drainage system
intervention type: Device
intervention name: Digital chest drainage system
description: patients who received Digital chest drainage system
arm group label: Experiment groups
intervention type: Device
intervention name: Not use Digital chest drainage system
description: patients who not received Digital chest drainage system( traditional drainage system)
arm group label: Control groups
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ching-Feng Wu, MD
role: Study Director
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Lung Diseases