<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/NCT01668368</url>
  </required_header>
  <id_info>
    <org_study_id>0082-12-WOMC</org_study_id>
    <nct_id>NCT01668368</nct_id>
  </id_info>
  <brief_title>Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance</brief_title>
  <official_title>Goal Directed Mechanical Ventilation Aimed at Optimal Lung Compliance Approach Guided by Esophageal Pressure in Acute Respiratory Failure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolfson Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with acute respiratory failure exhibiting decreased respiratory system compliance&#xD;
      with hypoxemia or carbon dioxide retention are often difficult to ventilate with current&#xD;
      guidelines that limit applied plateau pressure Yet, these guidelines do not take into&#xD;
      consideration chest wall mechanics. The investigators sought to determine whether partition&#xD;
      of the respiratory system into its components by measuring esophageal pressure and thus&#xD;
      assessment of pleural pressure, would help in patients with acute respiratory failure to&#xD;
      identify the factors contributing to low respiratory system compliance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Identifying the dominant factor affecting respiratory system compliance by measuring&#xD;
      transpulmonary pressure may better direct and optimize mechanical ventilation. Thus, instead&#xD;
      of limiting mechanical ventilation by plateau pressure, PEEP and Inspiratory pressure&#xD;
      adjustment would be individualized specifically for each patient's lung compliance as&#xD;
      indicated by transpulmonary pressure.&#xD;
&#xD;
      The main goal of this approach is to specifically target transpulmonary pressure instead of&#xD;
      plateau pressure, and therefore achieve the best Lung compliance with the least&#xD;
      transpulmonary pressure possible.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">September 2013</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygenation</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>lung compliance, expressed as ml/cmH2O.</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <condition>ARDS</condition>
  <arm_group>
    <arm_group_label>Esophageal balloon group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Esophageal balloon will be inserted, and esophageal pressure will be measured in patients with acute respiratory failure.&#xD;
Intervention - PEEP and Inspiratory pressure will be adjusted according to the measured esophageal pressure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>esophageal balloon</intervention_name>
    <description>esophageal pressure as a surrogate for pleural pressure</description>
    <arm_group_label>Esophageal balloon group</arm_group_label>
    <other_name>pleural pressure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be included in the study a prerequisite of high peak Inspiratory pressure (plateau&#xD;
             pressure of up to 30 cmH2O) had to be present, and at least one of the following four&#xD;
             inclusion criteria had to be met.&#xD;
&#xD;
             1 - Low Total Respiratory system compliance (CT), defined as less than 50ml/cmH2O. 2 -&#xD;
             P/F ratio of less than 300. 3 - Need for a PEEP greater than 10 cmH2O to maintain SaO2&#xD;
             of &gt; 90%. 4 - PCO2 over 60 mmHg, or PH less than 7.2 that is attributed to respiratory&#xD;
             acidosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any of the following were excluded from the study. Previous lung or&#xD;
             chest wall surgery, previous esophageal surgery, known Achalasia or any other&#xD;
             esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any&#xD;
             significant chest wall abnormality such as kyphoskoliosis.&#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>Arie Soroksky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wolfson MC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arie Soroksky, M.D.</last_name>
    <phone>972-50-4056787</phone>
    <email>soroksky@gmail.com</email>
  </overall_contact>
  <results_reference>
    <citation>Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.</citation>
    <PMID>19001507</PMID>
  </results_reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>August 14, 2012</last_update_submitted>
  <last_update_submitted_qc>August 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wolfson Medical Center</investigator_affiliation>
    <investigator_full_name>Soroksky Arie</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>ARDS</keyword>
  <keyword>Esophageal pressure</keyword>
  <keyword>pleural pressure</keyword>
  <keyword>pulmonary compliance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</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/NCT01668368
org study id: 0082-12-WOMC
nct id: NCT01668368
lead sponsor: 
has dmc: No
Patients with acute respiratory failure exhibiting decreased respiratory system compliance
      with hypoxemia or carbon dioxide retention are often difficult to ventilate with current
      guidelines that limit applied plateau pressure Yet, these guidelines do not take into
      consideration chest wall mechanics. The investigators sought to determine whether partition
      of the respiratory system into its components by measuring esophageal pressure and thus
      assessment of pleural pressure, would help in patients with acute respiratory failure to
      identify the factors contributing to low respiratory system compliance.
Identifying the dominant factor affecting respiratory system compliance by measuring
      transpulmonary pressure may better direct and optimize mechanical ventilation. Thus, instead
      of limiting mechanical ventilation by plateau pressure, PEEP and Inspiratory pressure
      adjustment would be individualized specifically for each patient's lung compliance as
      indicated by transpulmonary pressure.

      The main goal of this approach is to specifically target transpulmonary pressure instead of
      plateau pressure, and therefore achieve the best Lung compliance with the least
      transpulmonary pressure possible.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Oxygenation
time frame: 1 year
measure: lung compliance, expressed as ml/cmH2O.
time frame: 1 year
arm group label: Esophageal balloon group
arm group type: Other
description: Esophageal balloon will be inserted, and esophageal pressure will be measured in patients with acute respiratory failure.
Intervention - PEEP and Inspiratory pressure will be adjusted according to the measured esophageal pressure.
intervention type: Other
intervention name: esophageal balloon
description: esophageal pressure as a surrogate for pleural pressure
arm group label: Esophageal balloon group
other name: pleural pressure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arie Soroksky, MD
role: Principal Investigator
affiliation: Wolfson MC
last name: Arie Soroksky, M.D.
phone: 972-50-4056787
email: soroksky@gmail.com
citation: Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
PMID: 19001507
responsible party type: Principal Investigator
investigator affiliation: Wolfson Medical Center
investigator full name: Soroksky Arie
investigator title: M.D.
mesh term: Respiratory Insufficiency
mesh term: Respiratory Distress Syndrome