<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/NCT03281785</url>
  </required_header>
  <id_info>
    <org_study_id>MD%2f16.12.52</org_study_id>
    <nct_id>NCT03281785</nct_id>
  </id_info>
  <brief_title>Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.</brief_title>
  <official_title>Ultrasound Evaluation of the Diaphragmatic Musculature in Mechanically Ventilated Patients in Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</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>
      Muscle weakness and dysfunction are common problems in patients hospitalized in the intensive&#xD;
      care unit. Respiratory muscle weakness during mechanical ventilation was recognized a state&#xD;
      of muscular fatigue. The terminology 'ventilator-induced diaphragmatic dysfunction' (VIDD)&#xD;
      originally was introduced to describe these effects of mechanical ventilation and respiratory&#xD;
      muscle unloading on the diaphragm.&#xD;
&#xD;
      Ultrasonography is becoming increasingly popular management of ICU patients. It is a simple,&#xD;
      non-invasive and safe imaging technique that can be used for the assessment of distinctive&#xD;
      diaphragmatic characteristics.&#xD;
&#xD;
      Parameters such as amplitude and velocity of contraction, which can be assessed using M-mode&#xD;
      ultrasound. In addition, static and dynamic (thickening fraction during inspiration)&#xD;
      diaphragmatic thickness can also be measured by ultrasonography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to evaluate the effect of different modes of mechanical ventilation&#xD;
      on diaphragmatic thickness using ultrasonography and the relation between time of mechanical&#xD;
      ventilation and the percentage of change of diaphragmatic thickness in head trauma patients&#xD;
      subjected for mechanical ventilation (&gt;2 days) intensive care unit.&#xD;
&#xD;
      Modes of ventilation will be used in the study are:&#xD;
&#xD;
        -  Pressure controlled mandatory ventilation mode (P-CMV).&#xD;
&#xD;
        -  Pressure synchronized intermittent mandatory ventilation mode (P-SIMV).&#xD;
&#xD;
        -  Pressure support (PS) mode.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diaphragmatic thickness</measure>
    <time_frame>for 3 weeks after initiation of mechanical ventilation</time_frame>
    <description>changes in diaphragmatic thickness from baseline to nadir</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness</measure>
    <time_frame>for 3 weeks after initiation of mechanical ventilation</time_frame>
    <description>measurement of the diaphragmatic thickness as usual and calculate the percentage of change of the diaphragmatic thickness over the time of mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glasgow coma scale (GCS)</measure>
    <time_frame>for 2 weeks after initiation of mechanical ventilation.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sequential organ failure assessment (SOFA) score</measure>
    <time_frame>for 3 weeks after admission to the ICU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete blood picture</measure>
    <time_frame>for 3 weeks after admission to the ICU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coagulation profile</measure>
    <time_frame>for 3 weeks after admission to the ICU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver function</measure>
    <time_frame>for 3 weeks after admission to the ICU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function tests</measure>
    <time_frame>for 3 weeks after admission to the ICU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean blood pressure</measure>
    <time_frame>for 3 weeks after admission to the ICU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>for 3 weeks after admission to the ICU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial Oxygen Saturation</measure>
    <time_frame>for 3 weeks after admission to the ICU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central Venous Pressure</measure>
    <time_frame>for 3 weeks after admission to the ICU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>temperature</measure>
    <time_frame>for 3 weeks after admission to the ICU</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mode of ventilation</measure>
    <time_frame>for 3 weeks after initiation of mechanical ventilation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tidal volume</measure>
    <time_frame>for 3 weeks after initiation of mechanical ventilation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>respiratory rate</measure>
    <time_frame>for 3 weeks after initiation of mechanical ventilation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>airway pressure</measure>
    <time_frame>for 3 weeks after initiation of mechanical ventilation</time_frame>
    <description>peak and mean airway pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>for 3 weeks after initiation of mechanical ventilation</time_frame>
    <description>Time from admission to the ICU untill discharge or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>for 3 weeks after initiation of mechanical ventilation</time_frame>
    <description>time from initiation of mechanical ventilation till extubation or death</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Mechanical Ventilation</condition>
  <arm_group>
    <arm_group_label>Pressure controlled mandatory ventilation mode (P-CMV)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be ventilated using pressure controlled mandatory ventilation mode</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pressure synchronized intermittent mandatory ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be ventilated using pressure synchronized intermittent mandatory ventilation mode (P-SIMV)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pressure support mode (PS)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patents will be ventilated with pressure support mode (PS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pressure controlled mandatory ventilation mode (P-CMV)</intervention_name>
    <description>Pressure controlled mandatory ventilation mode (P-CMV)</description>
    <arm_group_label>Pressure controlled mandatory ventilation mode (P-CMV)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pressure synchronized intermittent mandatory ventilation</intervention_name>
    <description>Pressure synchronized intermittent mandatory ventilation</description>
    <arm_group_label>Pressure synchronized intermittent mandatory ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pressure support mode (PS)</intervention_name>
    <description>Pressure support mode (PS)</description>
    <arm_group_label>Pressure support mode (PS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status grades I and II.&#xD;
&#xD;
          -  Glasgow coma scale &lt; 8.&#xD;
&#xD;
          -  Selections of patients need mechanical ventilation (&gt;2 days).&#xD;
&#xD;
          -  Head trauma patients.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of diaphragmatic disease&#xD;
&#xD;
          -  Neuromuscular disease&#xD;
&#xD;
          -  Anatomical malformation of the diaphragm.&#xD;
&#xD;
          -  Patients with chest disease&#xD;
&#xD;
          -  Diabetic patients.&#xD;
&#xD;
          -  Chest trauma&#xD;
&#xD;
          -  Chest malignancy.&#xD;
&#xD;
          -  Use of non-invasive ventilation before the start of invasive ventilation.&#xD;
&#xD;
          -  Selection of patients of short period of mechanical ventilation (&lt; 2 days).&#xD;
&#xD;
          -  Hemodynamic instability.&#xD;
&#xD;
          -  Morbid obesity (body mass index &gt; 40 kg/m2).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amal R Ali, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of Anesthesia and Surgical Intensive Care</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanaa M Elbendary, MD</last_name>
    <role>Study Director</role>
    <affiliation>Professor of Anesthesia and Surgical Intensive Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University, Faculty of Medicine</name>
      <address>
        <city>Mansourah</city>
        <state>DK</state>
        <zip>050</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 26, 2019</last_update_submitted>
  <last_update_submitted_qc>March 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03281785
org study id: MD%2f16.12.52
nct id: NCT03281785
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Muscle weakness and dysfunction are common problems in patients hospitalized in the intensive
      care unit. Respiratory muscle weakness during mechanical ventilation was recognized a state
      of muscular fatigue. The terminology 'ventilator-induced diaphragmatic dysfunction' (VIDD)
      originally was introduced to describe these effects of mechanical ventilation and respiratory
      muscle unloading on the diaphragm.

      Ultrasonography is becoming increasingly popular management of ICU patients. It is a simple,
      non-invasive and safe imaging technique that can be used for the assessment of distinctive
      diaphragmatic characteristics.

      Parameters such as amplitude and velocity of contraction, which can be assessed using M-mode
      ultrasound. In addition, static and dynamic (thickening fraction during inspiration)
      diaphragmatic thickness can also be measured by ultrasonography.
The aim of this study is to evaluate the effect of different modes of mechanical ventilation
      on diaphragmatic thickness using ultrasonography and the relation between time of mechanical
      ventilation and the percentage of change of diaphragmatic thickness in head trauma patients
      subjected for mechanical ventilation (>2 days) intensive care unit.

      Modes of ventilation will be used in the study are:

        -  Pressure controlled mandatory ventilation mode (P-CMV).

        -  Pressure synchronized intermittent mandatory ventilation mode (P-SIMV).

        -  Pressure support (PS) mode.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Diaphragmatic thickness
time frame: for 3 weeks after initiation of mechanical ventilation
description: changes in diaphragmatic thickness from baseline to nadir
measure: The relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness
time frame: for 3 weeks after initiation of mechanical ventilation
description: measurement of the diaphragmatic thickness as usual and calculate the percentage of change of the diaphragmatic thickness over the time of mechanical ventilation
measure: Glasgow coma scale (GCS)
time frame: for 2 weeks after initiation of mechanical ventilation.
measure: Sequential organ failure assessment (SOFA) score
time frame: for 3 weeks after admission to the ICU
measure: Complete blood picture
time frame: for 3 weeks after admission to the ICU
measure: Coagulation profile
time frame: for 3 weeks after admission to the ICU
measure: Liver function
time frame: for 3 weeks after admission to the ICU
measure: Renal function tests
time frame: for 3 weeks after admission to the ICU
measure: Mean blood pressure
time frame: for 3 weeks after admission to the ICU
measure: Heart rate
time frame: for 3 weeks after admission to the ICU
measure: Arterial Oxygen Saturation
time frame: for 3 weeks after admission to the ICU
measure: Central Venous Pressure
time frame: for 3 weeks after admission to the ICU
measure: temperature
time frame: for 3 weeks after admission to the ICU
measure: mode of ventilation
time frame: for 3 weeks after initiation of mechanical ventilation
measure: tidal volume
time frame: for 3 weeks after initiation of mechanical ventilation
measure: respiratory rate
time frame: for 3 weeks after initiation of mechanical ventilation
measure: airway pressure
time frame: for 3 weeks after initiation of mechanical ventilation
description: peak and mean airway pressure
measure: ICU stay
time frame: for 3 weeks after initiation of mechanical ventilation
description: Time from admission to the ICU untill discharge or death
measure: Duration of mechanical ventilation
time frame: for 3 weeks after initiation of mechanical ventilation
description: time from initiation of mechanical ventilation till extubation or death
arm group label: Pressure controlled mandatory ventilation mode (P-CMV)
arm group type: Active Comparator
description: Patients will be ventilated using pressure controlled mandatory ventilation mode
arm group label: Pressure synchronized intermittent mandatory ventilation
arm group type: Active Comparator
description: Patients will be ventilated using pressure synchronized intermittent mandatory ventilation mode (P-SIMV)
arm group label: Pressure support mode (PS)
arm group type: Active Comparator
description: Patents will be ventilated with pressure support mode (PS)
intervention type: Other
intervention name: Pressure controlled mandatory ventilation mode (P-CMV)
description: Pressure controlled mandatory ventilation mode (P-CMV)
arm group label: Pressure controlled mandatory ventilation mode (P-CMV)
intervention type: Other
intervention name: Pressure synchronized intermittent mandatory ventilation
description: Pressure synchronized intermittent mandatory ventilation
arm group label: Pressure synchronized intermittent mandatory ventilation
intervention type: Other
intervention name: Pressure support mode (PS)
description: Pressure support mode (PS)
arm group label: Pressure support mode (PS)
criteria: 
gender: Male
gender based: Yes
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Amal R Ali, MD
role: Study Chair
affiliation: Professor of Anesthesia and Surgical Intensive Care
last name: Hanaa M Elbendary, MD
role: Study Director
affiliation: Professor of Anesthesia and Surgical Intensive Care
facility: 
country: Egypt
responsible party type: Sponsor
sharing ipd: Undecided