<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/NCT03040297</url>
  </required_header>
  <id_info>
    <org_study_id>13.4.4.25/05/16</org_study_id>
    <nct_id>NCT03040297</nct_id>
  </id_info>
  <brief_title>Effect of Parallel Oxygen Delivery Through a Tracheal Gas Insufflation (TGI) and a T-piece, on Blood Gases and Respiratory Rate, in ICU Tracheostomized Patients</brief_title>
  <official_title>Effect of Parallel Oxygen Delivery Through a Tracheal Gas Insufflation (TGI) and a T-piece on Blood Gases and Respiratory Rate in ICU Tracheostomized Patients as an Extra Supporting Method During Weaning From Mechanical Ventilation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Attikon Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National and Kapodistrian University of Athens</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Attikon Hospital</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>
      The study investigates if there are benefits (better oxygenation, minimized work of breath)&#xD;
      from the parallel oxygenation with Tracheal Gas Insufflation and T-piece, in order to provide&#xD;
      respiratory support in tracheostomized patients and avoid mechanical ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The tracheal insufflation (TGI) of respiratory gasses near to carina is a technique who&#xD;
      designed for the removement of exhaled carbon dioxide from the dead space of the lung. In&#xD;
      order to investigate the utility of this technique on weaning of mechanical ventilation 11&#xD;
      tracheostomized patients on T-piece were recruited, with stable blood gasses more than 24&#xD;
      hours.&#xD;
&#xD;
      A TGI catheter enters the trachea through a new opened hole on the top of T-piece and then&#xD;
      passes through the tracheostomy tube to inside of the trachea and then stops one centimeter&#xD;
      before the carina. Patients received two parallel administered respiratory gases with the&#xD;
      same fraction of inspired oxygen (FiO2), through a T-piece and an endotracheal catheter, with&#xD;
      flows 6 Liters Per Minute (L/min) and 11 L/min, while continuously monitored by impedance&#xD;
      tomography device (ΕΙΤ). ΕΙΤ is a noninvasive imaging technique for monitoring in real time&#xD;
      the lung volumes and the regional lung ventilation without ionizing radiation.&#xD;
&#xD;
      The basic hypothesis of the study is if there are benefits (better oxygenation, minimized&#xD;
      work of breath) from the parallel oxygenation with Tracheal Gas Insufflation and T-piece, in&#xD;
      order to provide respiratory support in tracheostomized patients and avoid mechanical&#xD;
      ventilation.&#xD;
&#xD;
      The randomization of the study was achieved using sealed envelopes method and associated with&#xD;
      the flow to be first (6L/min or 11L/min) via Tracheal Gas Insufflation Catheter (6 envelopes&#xD;
      with the inscription 6 L/min on the inner side and 6 envelopes with the inscription 6 L/min&#xD;
      on the inner side 11 L/min)&#xD;
&#xD;
      Τhe investigators tested the differences on partial pressure of oxygen (PaO2), respiratory&#xD;
      rate and end expiratory impedance:&#xD;
&#xD;
        1. Before gasses supply via TGI&#xD;
&#xD;
        2. During 6L/min&#xD;
&#xD;
        3. During 11L/min&#xD;
&#xD;
        4. And finally with no gasses supply via TGI&#xD;
&#xD;
      Additionally the following were monitored:&#xD;
&#xD;
        -  Heart rate&#xD;
&#xD;
        -  Systolic and diastolic blood pressure&#xD;
&#xD;
        -  Oxygen saturation as disturbing factors and,&#xD;
&#xD;
        -  potential of hydrogen (pH)&#xD;
&#xD;
        -  PaCO2&#xD;
&#xD;
        -  hydrogen carbonate (-HCO3) for the monitoring of the acid-base balance of the patient&#xD;
           during procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">January 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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Respiratory Rate</measure>
    <time_frame>60 minutes</time_frame>
    <description>Respiratory cycles per minute at flows: 0, 6, 11, 0 L/min</description>
  </primary_outcome>
  <primary_outcome>
    <measure>partial pressure of oxygen (PaO2)</measure>
    <time_frame>60 minutes</time_frame>
    <description>Arterial blood oxygen tension at flows: 0, 6, 11,0 L/min</description>
  </primary_outcome>
  <primary_outcome>
    <measure>End respiratory lung impedance differences</measure>
    <time_frame>60 minutes</time_frame>
    <description>End respiratory lung impedance differences at flows: 0, 6, 11, 0 L/min</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>60 minutes</time_frame>
    <description>Heart beats per minute at flows: 0, 6, 11, 0 L/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>60 minutes</time_frame>
    <description>Systolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>60 minutes</time_frame>
    <description>Diastolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation (SaO2)</measure>
    <time_frame>60 minutes</time_frame>
    <description>Oxygen saturation (%) at flows: 0, 6, 11, 0 L/min</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Resp Gas Exchange Disorder Nos</condition>
  <arm_group>
    <arm_group_label>TGI 6 L/min</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tracheal gas insufflation 6 L/min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TGI 11 L/min</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tracheal gas insufflation 11 L/min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TGI 0 L/min</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tracheal gas insufflation catheter, without gas flow</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tracheal gas insufflation 6 L/min</intervention_name>
    <description>Endotracheal flow (6 L/min) of respiratory gases with standard FiO2</description>
    <arm_group_label>TGI 6 L/min</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tracheal gas insufflation 11 L/min</intervention_name>
    <description>Endotracheal flow (11 L/min) of respiratory gases with standard FiO2</description>
    <arm_group_label>TGI 11 L/min</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tracheal gas insufflation catheter, without gas flow</intervention_name>
    <description>Tracheal gas insufflation catheter, without gas flow</description>
    <arm_group_label>TGI 0 L/min</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Tracheostomized haemodynamically stable patients, without the need of vasopressors or&#xD;
             inotrope medications, without symptoms of pulmonary edema, or interstitial lung&#xD;
             diseases.&#xD;
&#xD;
        Stable blood gasses (no bigger changes than 15-20% in Oxygen and Carbon dioxide during last&#xD;
        24 hours)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Peripheral body temperature &lt; 38 C, White blood cells (WBCs) &lt; 15 x 109/L&#xD;
&#xD;
          -  Respiratory rate &gt;35&#xD;
&#xD;
          -  Paradoxical breathing&#xD;
&#xD;
          -  Abdominal muscle recruitment&#xD;
&#xD;
          -  Dyspnoea, SaO2 &lt; 94, without evidence of angina, cyanosis or arrhythmia.&#xD;
&#xD;
          -  Chest circumferences no bigger than 110 cm (for the larger belt of impedance&#xD;
             tomograph)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>86 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Konstantinos E Grigoriadis, Pt, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>National and Kapodistrian University of Athens</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Iraklis Tsagaris, MD. PhD</last_name>
    <role>Study Chair</role>
    <affiliation>National and Kapodistrian University of Athens</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antonia D Koutsoukou, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>National and Kapodistrian University of Athens</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eirini P Grammatopoulou, PT, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Technological Educational Institution of Athens</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anna K Grigoriadou, PT</last_name>
    <role>Study Chair</role>
    <affiliation>Lamia University of Applied Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Apostolos E Armaganidis</last_name>
    <role>Study Director</role>
    <affiliation>National and Kapodistrian University of Athens</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Attikon University Hospital</name>
      <address>
        <city>Athens</city>
        <state>Attica</state>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Knebel AR. When weaning from mechanical ventilation fails. Am J Crit Care. 1992 Nov;1(3):19-29; quiz 30-1.</citation>
    <PMID>1307903</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>Blanch LL. Clinical studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):158-66.</citation>
    <PMID>11175244</PMID>
  </reference>
  <reference>
    <citation>Hoffman LA, Tasota FJ, Delgado E, Zullo TG, Pinsky MR. Effect of tracheal gas insufflation during weaning from prolonged mechanical ventilation: a preliminary study. Am J Crit Care. 2003 Jan;12(1):31-9.</citation>
    <PMID>12526235</PMID>
  </reference>
  <reference>
    <citation>Hess DR, Gillette MA. Tracheal gas insufflation and related techniques to introduce gas flow into the trachea. Respir Care. 2001 Feb;46(2):119-29.</citation>
    <PMID>11175241</PMID>
  </reference>
  <reference>
    <citation>Nahum A. Animal and lung model studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):149-57.</citation>
    <PMID>11175243</PMID>
  </reference>
  <reference>
    <citation>Kacmarek RM. Complications of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):167-76.</citation>
    <PMID>11175245</PMID>
  </reference>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 9, 2018</last_update_submitted>
  <last_update_submitted_qc>January 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Attikon Hospital</investigator_affiliation>
    <investigator_full_name>Konstantinos Grigoriadis</investigator_full_name>
    <investigator_title>Physical Therapist</investigator_title>
  </responsible_party>
  <keyword>Weaning from mechanical ventilation</keyword>
  <keyword>tracheostomized patients</keyword>
  <keyword>Tracheal gas insufflation</keyword>
  <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/NCT03040297
org study id: 13.4.4.25/05/16
nct id: NCT03040297
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study investigates if there are benefits (better oxygenation, minimized work of breath)
      from the parallel oxygenation with Tracheal Gas Insufflation and T-piece, in order to provide
      respiratory support in tracheostomized patients and avoid mechanical ventilation.
The tracheal insufflation (TGI) of respiratory gasses near to carina is a technique who
      designed for the removement of exhaled carbon dioxide from the dead space of the lung. In
      order to investigate the utility of this technique on weaning of mechanical ventilation 11
      tracheostomized patients on T-piece were recruited, with stable blood gasses more than 24
      hours.

      A TGI catheter enters the trachea through a new opened hole on the top of T-piece and then
      passes through the tracheostomy tube to inside of the trachea and then stops one centimeter
      before the carina. Patients received two parallel administered respiratory gases with the
      same fraction of inspired oxygen (FiO2), through a T-piece and an endotracheal catheter, with
      flows 6 Liters Per Minute (L/min) and 11 L/min, while continuously monitored by impedance
      tomography device (ΕΙΤ). ΕΙΤ is a noninvasive imaging technique for monitoring in real time
      the lung volumes and the regional lung ventilation without ionizing radiation.

      The basic hypothesis of the study is if there are benefits (better oxygenation, minimized
      work of breath) from the parallel oxygenation with Tracheal Gas Insufflation and T-piece, in
      order to provide respiratory support in tracheostomized patients and avoid mechanical
      ventilation.

      The randomization of the study was achieved using sealed envelopes method and associated with
      the flow to be first (6L/min or 11L/min) via Tracheal Gas Insufflation Catheter (6 envelopes
      with the inscription 6 L/min on the inner side and 6 envelopes with the inscription 6 L/min
      on the inner side 11 L/min)

      Τhe investigators tested the differences on partial pressure of oxygen (PaO2), respiratory
      rate and end expiratory impedance:

        1. Before gasses supply via TGI

        2. During 6L/min

        3. During 11L/min

        4. And finally with no gasses supply via TGI

      Additionally the following were monitored:

        -  Heart rate

        -  Systolic and diastolic blood pressure

        -  Oxygen saturation as disturbing factors and,

        -  potential of hydrogen (pH)

        -  PaCO2

        -  hydrogen carbonate (-HCO3) for the monitoring of the acid-base balance of the patient
           during procedure.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: Respiratory Rate
time frame: 60 minutes
description: Respiratory cycles per minute at flows: 0, 6, 11, 0 L/min
measure: partial pressure of oxygen (PaO2)
time frame: 60 minutes
description: Arterial blood oxygen tension at flows: 0, 6, 11,0 L/min
measure: End respiratory lung impedance differences
time frame: 60 minutes
description: End respiratory lung impedance differences at flows: 0, 6, 11, 0 L/min
measure: Heart Rate
time frame: 60 minutes
description: Heart beats per minute at flows: 0, 6, 11, 0 L/min
measure: Systolic blood pressure
time frame: 60 minutes
description: Systolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min
measure: Diastolic blood pressure
time frame: 60 minutes
description: Diastolic blood pressure (mmHg) at flows: 0, 6, 11, 0 L/min
measure: Oxygen saturation (SaO2)
time frame: 60 minutes
description: Oxygen saturation (%) at flows: 0, 6, 11, 0 L/min
arm group label: TGI 6 L/min
arm group type: Active Comparator
description: Tracheal gas insufflation 6 L/min
arm group label: TGI 11 L/min
arm group type: Active Comparator
description: Tracheal gas insufflation 11 L/min
arm group label: TGI 0 L/min
arm group type: Active Comparator
description: Tracheal gas insufflation catheter, without gas flow
intervention type: Device
intervention name: Tracheal gas insufflation 6 L/min
description: Endotracheal flow (6 L/min) of respiratory gases with standard FiO2
arm group label: TGI 6 L/min
intervention type: Device
intervention name: Tracheal gas insufflation 11 L/min
description: Endotracheal flow (11 L/min) of respiratory gases with standard FiO2
arm group label: TGI 11 L/min
intervention type: Device
intervention name: Tracheal gas insufflation catheter, without gas flow
description: Tracheal gas insufflation catheter, without gas flow
arm group label: TGI 0 L/min
criteria: 
gender: All
minimum age: 18 Years
maximum age: 86 Years
healthy volunteers: No
last name: Konstantinos E Grigoriadis, Pt, MSc
role: Principal Investigator
affiliation: National and Kapodistrian University of Athens
last name: Iraklis Tsagaris, MD. PhD
role: Study Chair
affiliation: National and Kapodistrian University of Athens
last name: Antonia D Koutsoukou, MD, PhD
role: Study Chair
affiliation: National and Kapodistrian University of Athens
last name: Eirini P Grammatopoulou, PT, PhD
role: Study Chair
affiliation: Technological Educational Institution of Athens
last name: Anna K Grigoriadou, PT
role: Study Chair
affiliation: Lamia University of Applied Sciences
last name: Apostolos E Armaganidis
role: Study Director
affiliation: National and Kapodistrian University of Athens
facility: 
country: Greece
citation: Knebel AR. When weaning from mechanical ventilation fails. Am J Crit Care. 1992 Nov;1(3):19-29; quiz 30-1.
PMID: 1307903
citation: Durbin CG Jr. Tracheostomy: why, when, and how? Respir Care. 2010 Aug;55(8):1056-68.
PMID: 20667153
citation: Blanch LL. Clinical studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):158-66.
PMID: 11175244
citation: Hoffman LA, Tasota FJ, Delgado E, Zullo TG, Pinsky MR. Effect of tracheal gas insufflation during weaning from prolonged mechanical ventilation: a preliminary study. Am J Crit Care. 2003 Jan;12(1):31-9.
PMID: 12526235
citation: Hess DR, Gillette MA. Tracheal gas insufflation and related techniques to introduce gas flow into the trachea. Respir Care. 2001 Feb;46(2):119-29.
PMID: 11175241
citation: Nahum A. Animal and lung model studies of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):149-57.
PMID: 11175243
citation: Kacmarek RM. Complications of tracheal gas insufflation. Respir Care. 2001 Feb;46(2):167-76.
PMID: 11175245
responsible party type: Principal Investigator
investigator affiliation: Attikon Hospital
investigator full name: Konstantinos Grigoriadis
investigator title: Physical Therapist
sharing ipd: No