<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/NCT03021369</url>
  </required_header>
  <id_info>
    <org_study_id>Medela1</org_study_id>
    <nct_id>NCT03021369</nct_id>
  </id_info>
  <brief_title>Comparison of Two Different Pleural Drainage Systems</brief_title>
  <official_title>Vergleich Zweier Thoraxdrainage-Systeme in Der Herzchirurgie</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kerckhoff Klinik</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kerckhoff Klinik</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The digital pleural drainage system Topaz+ by Medela is compared to the analogue system&#xD;
      Atrium OCEAN by Maquet in patients undergoing cardiac surgery.&#xD;
&#xD;
      The study is prospectively randomized with an all-comer setup. The patients are randomly&#xD;
      selected for one of the systems. The surgery is performed in the standard fashion and chest&#xD;
      tubes are placed routinely by the surgeon depending on the type of surgery. A retrosternal 32&#xD;
      French drain is placed in every patient and pericardial and/or pleural drains are optional.&#xD;
&#xD;
      The postoperative course does not vary from the clinical standard and the chest tubes are&#xD;
      removed according to institutional standard. The clinical data about fluid amount, time of&#xD;
      removal, air leaks, tamponade are routinely collected in a digital patient documentation&#xD;
      system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of air leak due to lung leakage or injury during surgery by the pleural drainage system.</measure>
    <time_frame>Occurrence of air leak is until the drain is removed (usually postoperative day 2 or 3)</time_frame>
    <description>The Thopaz+ system displays the amount of air leak on the screen in ml/min and the Ocean system is a 'wet seal' system, where bubbles in the box might indicate an air leak. If air leak is detected, the train cannot be removed and has to stay until no more air leak is detected. If air leak is unclear, chest x-rays with clamped drains are performed. If an pneumothorax is visible in the x-ray, the drains have to stay, otherwise they can be removed safely. The digital air leak detection and quantification by the Thopaz+ system might help in clearly detecting the air leaks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time of chest drain removal</measure>
    <time_frame>Number of days until the chest drains are removed (usually postoperative day 2 or 3, depending on air leak and amount of fluid).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluid amount</measure>
    <time_frame>Total amount of fluid at the time of chest drain removal (usually postoperative day 2 or 3, depending on air leak and amount of fluid).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with pericardial tamponade that has to be treated by puncture or surgically</measure>
    <time_frame>Occurrence through hospital stay (an average of 1 week).</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with pleural effusion at discharge echo, without intervention</measure>
    <time_frame>Occurrence through hospital stay (an average of 1 week).</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">374</enrollment>
  <condition>Air Leak From Lung</condition>
  <arm_group>
    <arm_group_label>Pleural drainage system Medela</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These patients receive the digital Medela system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pleural drainage system Ocean</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These patients receive the analogue Maquet system</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pleural drainage system</intervention_name>
    <description>Pleural drainage system is connected to the chest tubes after surgery.</description>
    <arm_group_label>Pleural drainage system Medela</arm_group_label>
    <arm_group_label>Pleural drainage system Ocean</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients undergoing cardiac surgery&#xD;
&#xD;
          -  capability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no specific exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kerckhoff Klinik</name>
      <address>
        <city>Bad Nauheim</city>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>February 22, 2020</last_update_submitted>
  <last_update_submitted_qc>February 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 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/NCT03021369
org study id: Medela1
nct id: NCT03021369
lead sponsor: 
has dmc: No
The digital pleural drainage system Topaz+ by Medela is compared to the analogue system
      Atrium OCEAN by Maquet in patients undergoing cardiac surgery.

      The study is prospectively randomized with an all-comer setup. The patients are randomly
      selected for one of the systems. The surgery is performed in the standard fashion and chest
      tubes are placed routinely by the surgeon depending on the type of surgery. A retrosternal 32
      French drain is placed in every patient and pericardial and/or pleural drains are optional.

      The postoperative course does not vary from the clinical standard and the chest tubes are
      removed according to institutional standard. The clinical data about fluid amount, time of
      removal, air leaks, tamponade are routinely collected in a digital patient documentation
      system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Detection of air leak due to lung leakage or injury during surgery by the pleural drainage system.
time frame: Occurrence of air leak is until the drain is removed (usually postoperative day 2 or 3)
description: The Thopaz+ system displays the amount of air leak on the screen in ml/min and the Ocean system is a 'wet seal' system, where bubbles in the box might indicate an air leak. If air leak is detected, the train cannot be removed and has to stay until no more air leak is detected. If air leak is unclear, chest x-rays with clamped drains are performed. If an pneumothorax is visible in the x-ray, the drains have to stay, otherwise they can be removed safely. The digital air leak detection and quantification by the Thopaz+ system might help in clearly detecting the air leaks.
measure: Time of chest drain removal
time frame: Number of days until the chest drains are removed (usually postoperative day 2 or 3, depending on air leak and amount of fluid).
measure: Fluid amount
time frame: Total amount of fluid at the time of chest drain removal (usually postoperative day 2 or 3, depending on air leak and amount of fluid).
measure: Number of patients with pericardial tamponade that has to be treated by puncture or surgically
time frame: Occurrence through hospital stay (an average of 1 week).
measure: Number of patients with pleural effusion at discharge echo, without intervention
time frame: Occurrence through hospital stay (an average of 1 week).
arm group label: Pleural drainage system Medela
arm group type: Active Comparator
description: These patients receive the digital Medela system
arm group label: Pleural drainage system Ocean
arm group type: Active Comparator
description: These patients receive the analogue Maquet system
intervention type: Device
intervention name: Pleural drainage system
description: Pleural drainage system is connected to the chest tubes after surgery.
arm group label: Pleural drainage system Medela
arm group label: Pleural drainage system Ocean
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Sponsor