<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/NCT01682486</url>
  </required_header>
  <id_info>
    <org_study_id>1842-2026-CDOC</org_study_id>
    <nct_id>NCT01682486</nct_id>
  </id_info>
  <brief_title>BIP ETT Clinical Tolerability, Safety and Performance Study</brief_title>
  <acronym>BIPETT</acronym>
  <official_title>Evaluation of Tolerability, Safety and Performance of BIP Endotracheal Tubes With Bactiguard Coating</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bactiguard AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bactiguard AB</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s&#xD;
      tolerability, safety and performance and compare it to a standard un-coated Endotracheal&#xD;
      tube.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tolerability assessment by using a symptom questionnaire (QLQ-H&amp;N35) before and after surgery. Evaluation of tracheal mucosa directly during surgery and after the end of study by using photos.</measure>
    <time_frame>Change from Baseline in symptoms and tracheal mucosa after surgery of expected average length of 5 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall assessment of safety (device related adverse events and any problems in post postoperative course)</measure>
    <time_frame>Participants will be followed on the surgery day and the day after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall assessment of device performance</measure>
    <time_frame>The performance will be followed during surgery of an expected average duration of 5 hours</time_frame>
    <description>Recording of any device related problems experienced by the physician/health care personnel</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Develop a method for surrogate performance evaluation by microbial colonization testing of bacteria from the ETT surface</measure>
    <time_frame>Microbial testing up to 1 day after surgery</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Endotracheal Intubation During Surgery</condition>
  <condition>Hospital Acquired Infections</condition>
  <arm_group>
    <arm_group_label>BIP ETT, Bactigaurd coated endotracheal tube</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard ETT, un-coated endotracheal tube</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BIP ETT (Bactiguard)</intervention_name>
    <description>Ventilation of surgery patients during anesthesia using BIP ETT</description>
    <arm_group_label>BIP ETT, Bactigaurd coated endotracheal tube</arm_group_label>
    <other_name>BIP Endotracheal tube</other_name>
    <other_name>Bactiguard coated ETT</other_name>
    <other_name>Bactiguard coated Endotracheal tube</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard ETT</intervention_name>
    <description>Ventilation of surgery patients during anesthesia using standard ETT</description>
    <arm_group_label>Standard ETT, un-coated endotracheal tube</arm_group_label>
    <other_name>ETT</other_name>
    <other_name>Endotracheal tube</other_name>
    <other_name>Standard Endotracheal tube</other_name>
    <other_name>Uncoated ETT</other_name>
    <other_name>Uncoated Endotracheal tube</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult men and women &gt;=18 years of age&#xD;
&#xD;
          -  are, in opinion of the investigator able to communicate with and understand the trial&#xD;
             personnel and comply with the requirements of the trial (e.g. fill in questionnaire)&#xD;
&#xD;
          -  requiring endotracheal intubation &gt;=3 h for elective surgery of upper gastrointestinal&#xD;
             tract with a tube size of 7 or 8&#xD;
&#xD;
          -  has signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known transmissive blood disease&#xD;
&#xD;
          -  known multiresistant bacterial colonization&#xD;
&#xD;
          -  current and continuous treatment by immunomodulating therapies - e.g. systemic (or&#xD;
             inhalation) use of cortisone or NSAIDS&#xD;
&#xD;
          -  ongoing respiratory infection&#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>Sigridur Kalman, MD PhD Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Huddinge</city>
        <state>Stockholm</state>
        <zip>SE-141 86</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <results_reference>
    <citation>Bjorling G, Johansson D, Bergstrom L, Jalal S, Kohn I, Frostell C, Kalman S. Tolerability and performance of BIP endotracheal tubes with noble metal alloy coating--a randomized clinical evaluation study. BMC Anesthesiol. 2015 Dec 1;15:174. doi: 10.1186/s12871-015-0156-z.</citation>
    <PMID>26625869</PMID>
  </results_reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>June 17, 2016</last_update_submitted>
  <last_update_submitted_qc>June 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medical device</keyword>
  <keyword>Endotracheal Tube(s), ETT</keyword>
  <keyword>Bactiguard Coated ETT</keyword>
  <keyword>Tolerability</keyword>
  <keyword>Safety</keyword>
  <keyword>Performance</keyword>
  <keyword>Bacterial colonization on ETT surface</keyword>
  <keyword>Hospital Acquired Infections, HAI</keyword>
  <keyword>Ventilator Associated Pneumonia, VAP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Cross Infection</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/NCT01682486
org study id: 1842-2026-CDOC
nct id: NCT01682486
lead sponsor: 
has dmc: Yes
The objective of the study is to determine Bactiguard coated BIP Endotracheal tube´s
      tolerability, safety and performance and compare it to a standard un-coated Endotracheal
      tube.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Tolerability assessment by using a symptom questionnaire (QLQ-H&N35) before and after surgery. Evaluation of tracheal mucosa directly during surgery and after the end of study by using photos.
time frame: Change from Baseline in symptoms and tracheal mucosa after surgery of expected average length of 5 hours
measure: Overall assessment of safety (device related adverse events and any problems in post postoperative course)
time frame: Participants will be followed on the surgery day and the day after surgery
measure: Overall assessment of device performance
time frame: The performance will be followed during surgery of an expected average duration of 5 hours
description: Recording of any device related problems experienced by the physician/health care personnel
measure: Develop a method for surrogate performance evaluation by microbial colonization testing of bacteria from the ETT surface
time frame: Microbial testing up to 1 day after surgery
arm group label: BIP ETT, Bactigaurd coated endotracheal tube
arm group type: Experimental
arm group label: Standard ETT, un-coated endotracheal tube
arm group type: Placebo Comparator
intervention type: Device
intervention name: BIP ETT (Bactiguard)
description: Ventilation of surgery patients during anesthesia using BIP ETT
arm group label: BIP ETT, Bactigaurd coated endotracheal tube
other name: BIP Endotracheal tube
other name: Bactiguard coated ETT
other name: Bactiguard coated Endotracheal tube
intervention type: Procedure
intervention name: Standard ETT
description: Ventilation of surgery patients during anesthesia using standard ETT
arm group label: Standard ETT, un-coated endotracheal tube
other name: ETT
other name: Endotracheal tube
other name: Standard Endotracheal tube
other name: Uncoated ETT
other name: Uncoated Endotracheal tube
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sigridur Kalman, MD PhD Prof
role: Principal Investigator
affiliation: Karolinska University Hospital
facility: 
country: Sweden
citation: Bjorling G, Johansson D, Bergstrom L, Jalal S, Kohn I, Frostell C, Kalman S. Tolerability and performance of BIP endotracheal tubes with noble metal alloy coating--a randomized clinical evaluation study. BMC Anesthesiol. 2015 Dec 1;15:174. doi: 10.1186/s12871-015-0156-z.
PMID: 26625869
responsible party type: Sponsor
mesh term: Infections
mesh term: Cross Infection
sharing ipd: No