<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/NCT01691222</url>
  </required_header>
  <id_info>
    <org_study_id>90/12</org_study_id>
    <nct_id>NCT01691222</nct_id>
  </id_info>
  <brief_title>Tracheostomy in ICU With a Double Lumen Endotracheal Tube</brief_title>
  <official_title>Percutaneous Tracheostomy in Intensive Care Unit With a Dedicated Double Lumen Endotracheal Tube</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Genova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Genova</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible&#xD;
      fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the&#xD;
      patients. This situation may lead to many disadvantages for ventilation and airway protection&#xD;
      of critically ill patients during the procedures. The use of double lumen endotracheal tube&#xD;
      dedicated to the percutaneous tracheostomies may:&#xD;
&#xD;
        1. improve the ventilation of patients during the procedure,&#xD;
&#xD;
        2. protect the posterior tracheal wall from damage related to the different step of&#xD;
           tracheostomies,&#xD;
&#xD;
        3. protect the lungs from blood and secretions coming down from the chosen site of&#xD;
           tracheostomy.&#xD;
&#xD;
      So the aim of this study is to evaluate the oxygenation, gas exchange, ventilation and&#xD;
      complications of percutaneous tracheostomies performed in ICU with a dedicated double lumen&#xD;
      endotracheal tube.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">December 2014</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in gas-exchange</measure>
    <time_frame>at the baseline and the end of the procedure (average time expected for the procedure is 30 minutes)</time_frame>
    <description>The investigator will perform an arterial blood gas to evaluate PaO2/FiO2 ratio</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in arterial carbon dioxide</measure>
    <time_frame>at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)</time_frame>
    <description>the investigator will perform an arterial blood gas to evaluate PaCO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in peak airway pressure</measure>
    <time_frame>at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)</time_frame>
    <description>the investigator will record peak airway pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in plateau airway pressure</measure>
    <time_frame>at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)</time_frame>
    <description>the investigator will record plateau airway pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in air-trapping</measure>
    <time_frame>at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)</time_frame>
    <description>the investigator will record auto-PEEP at the of expiration as a measure of air-trapping</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>early complications</measure>
    <time_frame>in the first 24 hours from the end of the procedure</time_frame>
    <description>early complications are:multiple intubation attempts (more than 1), accidental extubation, paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 1), surgical conversion and percutaneous tracheostomy failure, minor bleeding (compressible), major bleeding (incompressible), pneumothorax,</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>late complications</measure>
    <time_frame>from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)</time_frame>
    <description>late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <condition>Heart Failure</condition>
  <condition>Neurological Disease</condition>
  <arm_group>
    <arm_group_label>Double lumen endotracheal tube tracheostomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Tracheostomy with a dedicated double lumen endotracheal tube</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Double lumen endotracheal tube tracheostomy</intervention_name>
    <description>Percutaneous tracheostomy in this study will be performed with the use of a dedicated double-lumen endotracheal tube.&#xD;
The dedicated double-lumen endotracheal tube (Deas S.R.L, Italy) has an upper and a lower lumen. The upper one will be occupied by flexible fiberoptic bronchoscope while the lower one is exclusively dedicated to patient ventilation during the procedure. The lower lumen has a a semi-elliptical cross section. This tube will be placed in the patient airway with a direct laryngoscopy. After this intubation, a percutaneous dilatational tracheostomy will be performed with the standard techniques recognised in the literature.</description>
    <arm_group_label>Double lumen endotracheal tube tracheostomy</arm_group_label>
    <other_name>International Patent n° PCT/IT2012/000154</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years and at least one of following criteria:&#xD;
&#xD;
          -  prolonged endotracheal intubation&#xD;
&#xD;
          -  prolonged mechanical ventilation&#xD;
&#xD;
          -  difficult/prolonged weaning&#xD;
&#xD;
          -  inability to protect the airway&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infection of neck tissues&#xD;
&#xD;
          -  previous surgical neck interventions&#xD;
&#xD;
          -  recent surgical interventions or fracture of the cervical spine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>82 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paolo Pelosi, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Universita degli Studi di Genova</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Giuseppe Servillo, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Federico II University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paolo Pelosi, Professor</last_name>
    <phone>+39 010 555 3136</phone>
    <email>ppelosi@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Genoa</name>
      <address>
        <city>Genoa</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paolo Pelosi, Professor</last_name>
      <phone>+ 39 0101 5553136</phone>
      <email>ppelosi@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Paolo Pelosi, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maria Vargas, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Naples &quot;Federico II&quot;</name>
      <address>
        <city>Naples</city>
        <zip>80100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giuseppe Servillo, Professor</last_name>
      <phone>+39 081 7463552</phone>
      <email>servillo@unina.it</email>
    </contact>
    <investigator>
      <last_name>Giuseppe Servillo, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Rana S, Pendem S, Pogodzinski MS, Hubmayr RD, Gajic O. Tracheostomy in critically ill patients. Mayo Clin Proc. 2005 Dec;80(12):1632-8. doi: 10.4065/80.12.1632.</citation>
    <PMID>16342657</PMID>
  </reference>
  <reference>
    <citation>De Leyn P, Bedert L, Delcroix M, Depuydt P, Lauwers G, Sokolov Y, Van Meerhaeghe A, Van Schil P; Belgian Association of Pneumology and Belgian Association of Cardiothoracic Surgery. Tracheotomy: clinical review and guidelines. Eur J Cardiothorac Surg. 2007 Sep;32(3):412-21. doi: 10.1016/j.ejcts.2007.05.018. Epub 2007 Jun 27.</citation>
    <PMID>17588767</PMID>
  </reference>
  <reference>
    <citation>King C, Moores LK. Controversies in mechanical ventilation: when should a tracheotomy be placed? Clin Chest Med. 2008 Jun;29(2):253-63, vi. doi: 10.1016/j.ccm.2008.01.002.</citation>
    <PMID>18440435</PMID>
  </reference>
  <reference>
    <citation>Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.</citation>
    <PMID>20667153</PMID>
  </reference>
  <reference>
    <citation>Mallick A, Bodenham AR. Tracheostomy in critically ill patients. Eur J Anaesthesiol. 2010 Aug;27(8):676-82. doi: 10.1097/EJA.0b013e32833b1ba0.</citation>
    <PMID>20523214</PMID>
  </reference>
  <reference>
    <citation>Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9. doi: 10.1378/chest.87.6.715.</citation>
    <PMID>3996056</PMID>
  </reference>
  <reference>
    <citation>Fantoni A, Ripamonti D. A non-derivative, non-surgical tracheostomy: the translaryngeal method. Intensive Care Med. 1997 Apr;23(4):386-92. doi: 10.1007/s001340050345.</citation>
    <PMID>9142576</PMID>
  </reference>
  <reference>
    <citation>Griggs WM, Worthley LI, Gilligan JE, Thomas PD, Myburg JA. A simple percutaneous tracheostomy technique. Surg Gynecol Obstet. 1990 Jun;170(6):543-5.</citation>
    <PMID>2343371</PMID>
  </reference>
  <reference>
    <citation>Trottier SJ, Hazard PB, Sakabu SA, Levine JH, Troop BR, Thompson JA, McNary R. Posterior tracheal wall perforation during percutaneous dilational tracheostomy: an investigation into its mechanism and prevention. Chest. 1999 May;115(5):1383-9. doi: 10.1378/chest.115.5.1383.</citation>
    <PMID>10334157</PMID>
  </reference>
  <reference>
    <citation>Campos JH. Update on tracheobronchial anatomy and flexible fiberoptic bronchoscopy in thoracic anesthesia. Curr Opin Anaesthesiol. 2009 Feb;22(1):4-10. doi: 10.1097/ACO.0b013e32831a43ab.</citation>
    <PMID>19295287</PMID>
  </reference>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>July 2, 2013</last_update_submitted>
  <last_update_submitted_qc>July 2, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 3, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Genova</investigator_affiliation>
    <investigator_full_name>Paolo Pelosi</investigator_full_name>
    <investigator_title>Full Professor chair of Anesthesiology and Intensive Care Medicine. Chief of Intensive Care Unit</investigator_title>
  </responsible_party>
  <keyword>Bedside percutaneous tracheostomy</keyword>
  <keyword>Intensive Care Unit</keyword>
  <keyword>Dedicated Double-lumen tube</keyword>
  <keyword>Ineffective Airway Clearance</keyword>
  <keyword>weaning failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Nervous System 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/NCT01691222
org study id: 90/12
nct id: NCT01691222
lead sponsor: 
has dmc: Yes
Percutaneous tracheostomy in Intensive care unit (ICU) is performed with the use of flexible
      fiberoptic bronchoscope inside the conventional single lumen endotracheal tube owned by the
      patients. This situation may lead to many disadvantages for ventilation and airway protection
      of critically ill patients during the procedures. The use of double lumen endotracheal tube
      dedicated to the percutaneous tracheostomies may:

        1. improve the ventilation of patients during the procedure,

        2. protect the posterior tracheal wall from damage related to the different step of
           tracheostomies,

        3. protect the lungs from blood and secretions coming down from the chosen site of
           tracheostomy.

      So the aim of this study is to evaluate the oxygenation, gas exchange, ventilation and
      complications of percutaneous tracheostomies performed in ICU with a dedicated double lumen
      endotracheal tube.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: change in gas-exchange
time frame: at the baseline and the end of the procedure (average time expected for the procedure is 30 minutes)
description: The investigator will perform an arterial blood gas to evaluate PaO2/FiO2 ratio
measure: change in arterial carbon dioxide
time frame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
description: the investigator will perform an arterial blood gas to evaluate PaCO2
measure: change in peak airway pressure
time frame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
description: the investigator will record peak airway pressure
measure: change in plateau airway pressure
time frame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
description: the investigator will record plateau airway pressure
measure: change in air-trapping
time frame: at the baseline and at the end of the procedure (average time expected for the procedure is 30 minutes)
description: the investigator will record auto-PEEP at the of expiration as a measure of air-trapping
measure: early complications
time frame: in the first 24 hours from the end of the procedure
description: early complications are:multiple intubation attempts (more than 1), accidental extubation, paratracheal insertion, injuries to blood vessels in the neck, oesophageal injury, accidental decannulation, malposition of the tracheostomy tube, tracheal cuff puncture, multiple punctures (more than 1), surgical conversion and percutaneous tracheostomy failure, minor bleeding (compressible), major bleeding (incompressible), pneumothorax,
measure: late complications
time frame: from the 2nd day ofter the procedure until the ICU discharge (expected average of 2 weeks)
description: late complications are: minor bleeding (compressible), major bleeding (incompressible) tracheostomy puncture site infection, subglottic stenosis, fracture of a tracheal cartilage, granuloma.
arm group label: Double lumen endotracheal tube tracheostomy
arm group type: Other
description: Tracheostomy with a dedicated double lumen endotracheal tube
intervention type: Device
intervention name: Double lumen endotracheal tube tracheostomy
description: Percutaneous tracheostomy in this study will be performed with the use of a dedicated double-lumen endotracheal tube.
The dedicated double-lumen endotracheal tube (Deas S.R.L, Italy) has an upper and a lower lumen. The upper one will be occupied by flexible fiberoptic bronchoscope while the lower one is exclusively dedicated to patient ventilation during the procedure. The lower lumen has a a semi-elliptical cross section. This tube will be placed in the patient airway with a direct laryngoscopy. After this intubation, a percutaneous dilatational tracheostomy will be performed with the standard techniques recognised in the literature.
arm group label: Double lumen endotracheal tube tracheostomy
other name: International Patent n° PCT/IT2012/000154
criteria: 
gender: All
minimum age: 18 Years
maximum age: 82 Years
healthy volunteers: No
last name: Paolo Pelosi, Professor
role: Study Director
affiliation: Universita degli Studi di Genova
last name: Giuseppe Servillo, Professor
role: Study Director
affiliation: Federico II University
last name: Paolo Pelosi, Professor
phone: +39 010 555 3136
email: ppelosi@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
citation: Rana S, Pendem S, Pogodzinski MS, Hubmayr RD, Gajic O. Tracheostomy in critically ill patients. Mayo Clin Proc. 2005 Dec;80(12):1632-8. doi: 10.4065/80.12.1632.
PMID: 16342657
citation: De Leyn P, Bedert L, Delcroix M, Depuydt P, Lauwers G, Sokolov Y, Van Meerhaeghe A, Van Schil P; Belgian Association of Pneumology and Belgian Association of Cardiothoracic Surgery. Tracheotomy: clinical review and guidelines. Eur J Cardiothorac Surg. 2007 Sep;32(3):412-21. doi: 10.1016/j.ejcts.2007.05.018. Epub 2007 Jun 27.
PMID: 17588767
citation: King C, Moores LK. Controversies in mechanical ventilation: when should a tracheotomy be placed? Clin Chest Med. 2008 Jun;29(2):253-63, vi. doi: 10.1016/j.ccm.2008.01.002.
PMID: 18440435
citation: Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
PMID: 20667153
citation: Mallick A, Bodenham AR. Tracheostomy in critically ill patients. Eur J Anaesthesiol. 2010 Aug;27(8):676-82. doi: 10.1097/EJA.0b013e32833b1ba0.
PMID: 20523214
citation: Ciaglia P, Firsching R, Syniec C. Elective percutaneous dilatational tracheostomy. A new simple bedside procedure; preliminary report. Chest. 1985 Jun;87(6):715-9. doi: 10.1378/chest.87.6.715.
PMID: 3996056
citation: Fantoni A, Ripamonti D. A non-derivative, non-surgical tracheostomy: the translaryngeal method. Intensive Care Med. 1997 Apr;23(4):386-92. doi: 10.1007/s001340050345.
PMID: 9142576
citation: Griggs WM, Worthley LI, Gilligan JE, Thomas PD, Myburg JA. A simple percutaneous tracheostomy technique. Surg Gynecol Obstet. 1990 Jun;170(6):543-5.
PMID: 2343371
citation: Trottier SJ, Hazard PB, Sakabu SA, Levine JH, Troop BR, Thompson JA, McNary R. Posterior tracheal wall perforation during percutaneous dilational tracheostomy: an investigation into its mechanism and prevention. Chest. 1999 May;115(5):1383-9. doi: 10.1378/chest.115.5.1383.
PMID: 10334157
citation: Campos JH. Update on tracheobronchial anatomy and flexible fiberoptic bronchoscopy in thoracic anesthesia. Curr Opin Anaesthesiol. 2009 Feb;22(1):4-10. doi: 10.1097/ACO.0b013e32831a43ab.
PMID: 19295287
responsible party type: Principal Investigator
investigator affiliation: University of Genova
investigator full name: Paolo Pelosi
investigator title: Full Professor chair of Anesthesiology and Intensive Care Medicine. Chief of Intensive Care Unit
mesh term: Respiratory Insufficiency
mesh term: Nervous System Diseases