<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/NCT01722981</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-12-PS-0408-12-CTIL</org_study_id>
    <nct_id>NCT01722981</nct_id>
  </id_info>
  <brief_title>Percutaneous Tracheostomy - Systematic Comparison Among Three Methods: Prospective Study</brief_title>
  <official_title>Percutaneous Tracheostomy - Systematic Comparison Among Three Methods: US-guided Tracheostomy, Bronchoscopy Guided Tracheostomy, and Direct Laryngoscopy Tracheostomy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Percutaneous tracheostomy is routinely performed in most intensive care units in the&#xD;
      world.Several studies have shown that the procedure is safe and economically efficient in&#xD;
      comparison to open surgical operation in the operating room.&#xD;
&#xD;
      In our institution as in a number of institutions in the country, it is acceptable to perform&#xD;
      the operation by placing the tube on a high position near the vocal cords by direct&#xD;
      laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by&#xD;
      palpation of the neck.&#xD;
&#xD;
      Using technological aids, such as direct sonography and bronchoscopy in real time may&#xD;
      significantly reduce the rate of complications as a result of performing percutaneous&#xD;
      tracheostomy.&#xD;
&#xD;
      So far, no systematic comparison has been made among the three methods.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Percutaneous tracheostomy is routinely performed in most intensive care units in the world in&#xD;
      a number of indications, such as: airway obstruction, need for a long respiratory support,&#xD;
      improvement in respiratory toilet, prophylaxis before head and neck procedures and cases of&#xD;
      severe obstructive sleep apnea.&#xD;
&#xD;
      Several studies have shown that the procedure is safe and economically efficient in&#xD;
      comparison to open surgical operation in the operating room.&#xD;
&#xD;
      In many places around the world it is customary in to perform the operation under the&#xD;
      guidance of a bronchoscope to prevent damage to adjacent structures, high or low position of&#xD;
      the tube, and damage to the posterior wall of the trachea and to approve the final position&#xD;
      of the tube. However, the use of a bronchoscope depends on the availability of the equipment,&#xD;
      knowledge of the operator, temporary occlusion of the trachea and hypercarbia, increased&#xD;
      length of the procedure, and maintenance cost (disinfection, replacement, etc.).&#xD;
&#xD;
      Ultrasound that is performed before percutaneous procedure may be useful in preventing damage&#xD;
      to para tracheal adjacent structures, and preventing high placement of the tube. The use of&#xD;
      duplex sonography with real-time visualization of the needle path is done routinely in&#xD;
      procedures such as central venous catheterization, and may improve the safety and accuracy of&#xD;
      percutaneous tracheostomy without causing airway obstruction or hypercarbia. Feasibility of&#xD;
      the procedure has been reviewed in an article by Rajajee et al .&#xD;
&#xD;
      In our institution as in a number of institutions in the country, it is acceptable to perform&#xD;
      the operation by placing the tube on a high position near the vocal cords by direct&#xD;
      laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by&#xD;
      palpation of the neck.&#xD;
&#xD;
      So far, no systematic comparison has been made among the three methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">January 2016</completion_date>
  <primary_completion_date type="Anticipated">January 2016</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Systematic comparison</measure>
    <time_frame>3 years</time_frame>
    <description>a systematic comparison among the three methods of percutaneous tracheostomy in terms of safety: minor and major periprocedural morbidity and mortality, up to 30 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minor morbidity</measure>
    <time_frame>3 years</time_frame>
    <description>Minor morbidity among patients, and a comparison between the in-house patients to the rest of hospitalized patients that come to the unit for the procedure, according to the same criteria.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Other Tracheostomy Complication</condition>
  <arm_group>
    <arm_group_label>Direct laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Performing percutaneous tracheostomy as accepted in our institute: By placing the tube higher up near the vocal cords by direct laryngoscopy. In the second stage tracheal perforation by a needle will be carried out by palpation of the anatomical placement of the neck.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Real time sonography</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Percutaneous tracheostomy will be guided by real time sonography (with the visualization of the needle path) using acoustic shadows of the cricoid and the tracheal rings.&#xD;
In both methods, in order to identify the anatomic location of the needle prick- after passing the guide wire, the front elevation will be verified by optical means, which will be drawn out immediately afterwards.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bronchoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Percutaneous tracheostomy will be guided by bronchoscopy. Initially, the tube will be placed according to the desired height observed by the bronchoscope, phase two will be tracheal perforation by a needle under trans illumination and real-time view on the income of the needle and the passage of the guide wire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Percutaneous tracheostomy</intervention_name>
    <description>Three methods of percutaneous tracheostomy</description>
    <arm_group_label>Bronchoscopy</arm_group_label>
    <arm_group_label>Direct laryngoscopy</arm_group_label>
    <arm_group_label>Real time sonography</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All intubated patients with various injuries requiring percutaneous tracheostomy (in-&#xD;
             house and out- house patients)&#xD;
&#xD;
          -  Minimal age 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No patient consent for participation.&#xD;
&#xD;
          -  Anatomical problem which does not allow for percutaneous tracheostomy and requires&#xD;
             open procedure in the operating room.&#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>Patrick Sorkine, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tel-Aviv Sourasky Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tel-Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel-Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Akiva Nachshon, MD</last_name>
      <phone>972-52-4266342</phone>
      <email>medethic@bgu.ac.il</email>
    </contact>
    <investigator>
      <last_name>Akiva Nachshon, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 4, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>November 13, 2012</last_update_submitted>
  <last_update_submitted_qc>November 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</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/NCT01722981
org study id: TASMC-12-PS-0408-12-CTIL
nct id: NCT01722981
lead sponsor: 
has dmc: Yes
Percutaneous tracheostomy is routinely performed in most intensive care units in the
      world.Several studies have shown that the procedure is safe and economically efficient in
      comparison to open surgical operation in the operating room.

      In our institution as in a number of institutions in the country, it is acceptable to perform
      the operation by placing the tube on a high position near the vocal cords by direct
      laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by
      palpation of the neck.

      Using technological aids, such as direct sonography and bronchoscopy in real time may
      significantly reduce the rate of complications as a result of performing percutaneous
      tracheostomy.

      So far, no systematic comparison has been made among the three methods.
Percutaneous tracheostomy is routinely performed in most intensive care units in the world in
      a number of indications, such as: airway obstruction, need for a long respiratory support,
      improvement in respiratory toilet, prophylaxis before head and neck procedures and cases of
      severe obstructive sleep apnea.

      Several studies have shown that the procedure is safe and economically efficient in
      comparison to open surgical operation in the operating room.

      In many places around the world it is customary in to perform the operation under the
      guidance of a bronchoscope to prevent damage to adjacent structures, high or low position of
      the tube, and damage to the posterior wall of the trachea and to approve the final position
      of the tube. However, the use of a bronchoscope depends on the availability of the equipment,
      knowledge of the operator, temporary occlusion of the trachea and hypercarbia, increased
      length of the procedure, and maintenance cost (disinfection, replacement, etc.).

      Ultrasound that is performed before percutaneous procedure may be useful in preventing damage
      to para tracheal adjacent structures, and preventing high placement of the tube. The use of
      duplex sonography with real-time visualization of the needle path is done routinely in
      procedures such as central venous catheterization, and may improve the safety and accuracy of
      percutaneous tracheostomy without causing airway obstruction or hypercarbia. Feasibility of
      the procedure has been reviewed in an article by Rajajee et al .

      In our institution as in a number of institutions in the country, it is acceptable to perform
      the operation by placing the tube on a high position near the vocal cords by direct
      laryngoscopy and then puncturing the trachea with a needle, by location of the anatomy by
      palpation of the neck.

      So far, no systematic comparison has been made among the three methods.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Systematic comparison
time frame: 3 years
description: a systematic comparison among the three methods of percutaneous tracheostomy in terms of safety: minor and major periprocedural morbidity and mortality, up to 30 days.
measure: Minor morbidity
time frame: 3 years
description: Minor morbidity among patients, and a comparison between the in-house patients to the rest of hospitalized patients that come to the unit for the procedure, according to the same criteria.
arm group label: Direct laryngoscopy
arm group type: Active Comparator
description: Performing percutaneous tracheostomy as accepted in our institute: By placing the tube higher up near the vocal cords by direct laryngoscopy. In the second stage tracheal perforation by a needle will be carried out by palpation of the anatomical placement of the neck.
arm group label: Real time sonography
arm group type: Active Comparator
description: Percutaneous tracheostomy will be guided by real time sonography (with the visualization of the needle path) using acoustic shadows of the cricoid and the tracheal rings.
In both methods, in order to identify the anatomic location of the needle prick- after passing the guide wire, the front elevation will be verified by optical means, which will be drawn out immediately afterwards.
arm group label: Bronchoscopy
arm group type: Active Comparator
description: Percutaneous tracheostomy will be guided by bronchoscopy. Initially, the tube will be placed according to the desired height observed by the bronchoscope, phase two will be tracheal perforation by a needle under trans illumination and real-time view on the income of the needle and the passage of the guide wire.
intervention type: Procedure
intervention name: Percutaneous tracheostomy
description: Three methods of percutaneous tracheostomy
arm group label: Bronchoscopy
arm group label: Direct laryngoscopy
arm group label: Real time sonography
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick Sorkine, professor
role: Principal Investigator
affiliation: Tel-Aviv Sourasky Medical Center
facility: 
contact: 
investigator: 
country: Israel
responsible party type: Sponsor