<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/NCT03000504</url>
  </required_header>
  <id_info>
    <org_study_id>217496</org_study_id>
    <nct_id>NCT03000504</nct_id>
  </id_info>
  <brief_title>Ballooned Intercostal Drain Trial</brief_title>
  <official_title>A Randomized, Controlled Trial of the Use of a Dedicated Ballooned Intercostal Tube</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Brompton &amp; Harefield NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sherwood Forest Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Brompton &amp; Harefield NHS Foundation Trust</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>
      This study is designed to assess whether a new type of chest drain reduces the number of&#xD;
      drains that fall out of or are accidentally removed from the chest cavity (usually requiring&#xD;
      another drain to be inserted), without causing any increase in discomfort or other&#xD;
      side-effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chest drains are an essential part of the treatment for patients with fluid or air around the&#xD;
      lung, which usually causes breathlessness. Draining the fluid or air relieves symptoms and&#xD;
      allows investigations to be carried out that can identify a cause for why the fluid or air is&#xD;
      there. Chest drains are difficult to secure in place, and sometimes fall out despite the best&#xD;
      possible care. This study tests a modified drain that has a small balloon near the end which,&#xD;
      when inflated inside the chest cavity, should make it much harder for the drain to fall out&#xD;
      of the chest. This was tested in a small pilot study, with encouraging results. The current&#xD;
      study is comparing a group of patients treated with the new ballooned drain against a group&#xD;
      treated with the standard drain, with patients equally but randomly allocated to each group.&#xD;
      The chest drain has been through rigorous laboratory testing and has been CE marked for human&#xD;
      use.&#xD;
&#xD;
      All patients requiring intercostal drainage for clinical reasons will be offered entry into&#xD;
      the study, unless, in the view of the treating physician, blunt dissection is required. No&#xD;
      other screening assessments will be required, other than the ability to sign the informed&#xD;
      consent form.Patients who have provided signed informed consent will then proceed to the&#xD;
      study protocol. Patients will be randomised to undergo either standard ICT insertion (usual&#xD;
      clinical care) or insertion of the study drain using standard clinical policies and&#xD;
      procedures at each participating centre.&#xD;
&#xD;
      Once a patient has been identified for the trial and has signed the informed consent form,&#xD;
      baseline details will be entered into a dedicated web-based programme accessible at all&#xD;
      sites, and patients will be allocated 1:1 to either usual care or to the study drain.&#xD;
&#xD;
      All subsequent care will be as per best clinical care for all patients in both arms of the&#xD;
      study. The only additional assessments over and above usual care will be the collection of&#xD;
      pain scores. Pain will be rated by the patients on a visual analogue scale (VAS) on up to 4&#xD;
      occasions - insertion, 24 and 72 hours post insertion, and at drain removal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 7, 2018</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</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>The difference in the percentage of accidental removal of ICTs between study arms</measure>
    <time_frame>Up to 1 week dependent upon duration of intercostal drainage</time_frame>
    <description>The number of drains prematurely and unintentionally removed from the pleural space</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The difference in patient reported pain scores, using a visual analogue scale</measure>
    <time_frame>At drain insertion, 24hrs post-insertion, 72hrs-post insertion, and at drain removal, usually a maximum of 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The frequency of balloon rupture</measure>
    <time_frame>Up to 1 week dependent upon duration of intercostal drainage</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The difference in duration of drainage between the study arms</measure>
    <time_frame>Up to 1 week dependent upon duration of intercostal drainage</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness profiles for each intervention</measure>
    <time_frame>Up to 1 week dependent upon duration of intercostal drainage</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">178</enrollment>
  <condition>Pleural Effusion</condition>
  <condition>Pneumothorax</condition>
  <arm_group>
    <arm_group_label>Ballooned intercostal drain</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will have a Rocket Medical 16F ballooned chest drain inserted as per usual clinical guidelines. No other change to treatment will be made, and the drain is inserted in exactly the same way as a standard drain, using the Seldinger technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard intercostal drain</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will have a standard 12F-16F Rocket Medical chest drain inserted as per usual clinical guidelines, using the Seldinger technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ballooned intercostal drain</intervention_name>
    <description>Patients will have a Rocket Medical 16F ballooned intercostal drain inserted as per usual clinical guidelines. No other change to treatment will be made, and the drain is inserted in exactly the same way as a standard drain, using the Seldinger technique.</description>
    <arm_group_label>Ballooned intercostal drain</arm_group_label>
    <arm_group_label>Standard intercostal drain</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;16 years&#xD;
&#xD;
          2. Able to give written informed consent&#xD;
&#xD;
          3. Requiring intercostal tube drainage for clinical reasons&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to provide written informed consent&#xD;
&#xD;
          2. Requiring blunt dissection for intercostal tube insertion&#xD;
&#xD;
          3. Haemothorax&#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>Samuel V Kemp, MBBS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Brompton and Harefield NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Samuel V Kemp, MBBS, MD</last_name>
    <phone>+442073518021</phone>
    <email>s.kemp@rbht.nhs.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sherwood Forest Hospitals NHS Foundation Trusty</name>
      <address>
        <city>Sutton in Ashfield</city>
        <state>Nottinghamshire</state>
        <zip>NG17 4JL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicola J Downer, MBBS</last_name>
      <phone>+441623622515</phone>
      <email>nicola.downer@sfh-tr.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Oxford Respiratory Trials Unit</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Najib Rahman, PhD</last_name>
      <phone>+441865 225256</phone>
      <email>najib.rahman@ndm.ox.ac.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Brompton Hospital</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Samuel V Kemp, MBBS MD</last_name>
      <phone>+442073518021</phone>
      <email>s.kemp@rbht.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>May 10, 2018</last_update_submitted>
  <last_update_submitted_qc>May 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2018</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>Pleural Effusion</mesh_term>
    <mesh_term>Pneumothorax</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03000504
org study id: 217496
nct id: NCT03000504
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is designed to assess whether a new type of chest drain reduces the number of
      drains that fall out of or are accidentally removed from the chest cavity (usually requiring
      another drain to be inserted), without causing any increase in discomfort or other
      side-effects.
Chest drains are an essential part of the treatment for patients with fluid or air around the
      lung, which usually causes breathlessness. Draining the fluid or air relieves symptoms and
      allows investigations to be carried out that can identify a cause for why the fluid or air is
      there. Chest drains are difficult to secure in place, and sometimes fall out despite the best
      possible care. This study tests a modified drain that has a small balloon near the end which,
      when inflated inside the chest cavity, should make it much harder for the drain to fall out
      of the chest. This was tested in a small pilot study, with encouraging results. The current
      study is comparing a group of patients treated with the new ballooned drain against a group
      treated with the standard drain, with patients equally but randomly allocated to each group.
      The chest drain has been through rigorous laboratory testing and has been CE marked for human
      use.

      All patients requiring intercostal drainage for clinical reasons will be offered entry into
      the study, unless, in the view of the treating physician, blunt dissection is required. No
      other screening assessments will be required, other than the ability to sign the informed
      consent form.Patients who have provided signed informed consent will then proceed to the
      study protocol. Patients will be randomised to undergo either standard ICT insertion (usual
      clinical care) or insertion of the study drain using standard clinical policies and
      procedures at each participating centre.

      Once a patient has been identified for the trial and has signed the informed consent form,
      baseline details will be entered into a dedicated web-based programme accessible at all
      sites, and patients will be allocated 1:1 to either usual care or to the study drain.

      All subsequent care will be as per best clinical care for all patients in both arms of the
      study. The only additional assessments over and above usual care will be the collection of
      pain scores. Pain will be rated by the patients on a visual analogue scale (VAS) on up to 4
      occasions - insertion, 24 and 72 hours post insertion, and at drain removal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The difference in the percentage of accidental removal of ICTs between study arms
time frame: Up to 1 week dependent upon duration of intercostal drainage
description: The number of drains prematurely and unintentionally removed from the pleural space
measure: The difference in patient reported pain scores, using a visual analogue scale
time frame: At drain insertion, 24hrs post-insertion, 72hrs-post insertion, and at drain removal, usually a maximum of 7 days
measure: The frequency of balloon rupture
time frame: Up to 1 week dependent upon duration of intercostal drainage
measure: The difference in duration of drainage between the study arms
time frame: Up to 1 week dependent upon duration of intercostal drainage
measure: Cost-effectiveness profiles for each intervention
time frame: Up to 1 week dependent upon duration of intercostal drainage
arm group label: Ballooned intercostal drain
arm group type: Experimental
description: Patients will have a Rocket Medical 16F ballooned chest drain inserted as per usual clinical guidelines. No other change to treatment will be made, and the drain is inserted in exactly the same way as a standard drain, using the Seldinger technique.
arm group label: Standard intercostal drain
arm group type: Active Comparator
description: Patients will have a standard 12F-16F Rocket Medical chest drain inserted as per usual clinical guidelines, using the Seldinger technique.
intervention type: Device
intervention name: Ballooned intercostal drain
description: Patients will have a Rocket Medical 16F ballooned intercostal drain inserted as per usual clinical guidelines. No other change to treatment will be made, and the drain is inserted in exactly the same way as a standard drain, using the Seldinger technique.
arm group label: Ballooned intercostal drain
arm group label: Standard intercostal drain
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samuel V Kemp, MBBS, MD
role: Principal Investigator
affiliation: Royal Brompton and Harefield NHS Foundation Trust
last name: Samuel V Kemp, MBBS, MD
phone: +442073518021
email: s.kemp@rbht.nhs.uk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Pleural Effusion
mesh term: Pneumothorax
sharing ipd: No