<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/NCT03824301</url>
  </required_header>
  <id_info>
    <org_study_id>ASCSH32/17</org_study_id>
    <nct_id>NCT03824301</nct_id>
  </id_info>
  <brief_title>Different Modes of Ventilation During Cardiopulmonary Bypass</brief_title>
  <official_title>Comparative Study Between Different Modes of Ventilation During Cardiopulmonary Bypass and Its Effect on Postoperative Pulmonary Dysfunction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      66 patients divided into 3 groups with different modes of ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty-six patients going through open-heart surgeries were included in the study, divided&#xD;
      into 3 groups (P: pressure controlled ventilation, V: volume controlled ventilation, C:&#xD;
      control) in accordance with the mode of ventilation. Patients studied for chest x-ray, lung&#xD;
      ultrasound, arterial oxygen partial pressure to fractional inspired oxygen ratio (PaO2/FiO2),&#xD;
      Alveolar-arterial oxygen gradient, static lung compliance and dynamic lung compliance, taken&#xD;
      after induction of anesthesia, 1h post cardiopulmonary bypass, 1h after arrival to cardiac&#xD;
      surgical unit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2017</start_date>
  <completion_date type="Actual">November 20, 2018</completion_date>
  <primary_completion_date type="Actual">March 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>chest x-ray</measure>
    <time_frame>after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.</time_frame>
    <description>Chest x ray to detect any lung pathology or changes from baseline like pleural effusion, pulmonary edema or pneumonia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lung ultrasonography</measure>
    <time_frame>after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.</time_frame>
    <description>Lung ultrasonography to detect any lung changes from baseline or development of consolidation, pulmonary edema or pleural effusion</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Postoperative Pulmonary Dysfunction</condition>
  <arm_group>
    <arm_group_label>Volume-controlled ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During cardiopulmonary bypass period the patients were ventilated with volume-controlled ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pressure-controlled ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During cardiopulmonary bypass period the patients were ventilated with pressure-controlled ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No ventilation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>During cardiopulmonary bypass period the patients were disconnected from ventilator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Volume controlled ventilation</intervention_name>
    <description>Changing modes of ventilation during cardiopulmonary bypass</description>
    <arm_group_label>Volume-controlled ventilation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pressure controlled ventilation</intervention_name>
    <description>Applying pressure controlled ventilation during cardiopulmonary bypass Period</description>
    <arm_group_label>Pressure-controlled ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoingvalve surgeries&#xD;
&#xD;
          -  Patients undergoing coronary artery bypass grafting surgeries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency cases.&#xD;
&#xD;
          -  Off-pump surgeries.&#xD;
&#xD;
          -  Patients with chronic lung diseases with forced expiratory volume in first second&#xD;
             (FEV1) or forced vital capacity (FVC) less than 40% of the predicted value.&#xD;
&#xD;
          -  Massive blood transfusion during surgery.&#xD;
&#xD;
          -  Complicated surgeries.&#xD;
&#xD;
          -  Redo surgeries.&#xD;
&#xD;
          -  Patients with decompensated heart failure prior to surgery.&#xD;
&#xD;
          -  Patients refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams University cardiothoracic hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ayman Anis Metry</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>cardiopulmonary bypass</keyword>
  <keyword>pressure-controlled ventilation</keyword>
  <keyword>volume-controlled ventilation</keyword>
  <keyword>atelectasis</keyword>
  <keyword>pleural effusion</keyword>
  <keyword>lung compliance</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/NCT03824301
org study id: ASCSH32/17
nct id: NCT03824301
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
66 patients divided into 3 groups with different modes of ventilation.
Sixty-six patients going through open-heart surgeries were included in the study, divided
      into 3 groups (P: pressure controlled ventilation, V: volume controlled ventilation, C:
      control) in accordance with the mode of ventilation. Patients studied for chest x-ray, lung
      ultrasound, arterial oxygen partial pressure to fractional inspired oxygen ratio (PaO2/FiO2),
      Alveolar-arterial oxygen gradient, static lung compliance and dynamic lung compliance, taken
      after induction of anesthesia, 1h post cardiopulmonary bypass, 1h after arrival to cardiac
      surgical unit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: chest x-ray
time frame: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.
description: Chest x ray to detect any lung pathology or changes from baseline like pleural effusion, pulmonary edema or pneumonia
measure: lung ultrasonography
time frame: after induction of anesthesia, 1hour post cardiopulmonary bypass and 1hour after arrival to cardiac surgical unit.
description: Lung ultrasonography to detect any lung changes from baseline or development of consolidation, pulmonary edema or pleural effusion
arm group label: Volume-controlled ventilation
arm group type: Active Comparator
description: During cardiopulmonary bypass period the patients were ventilated with volume-controlled ventilation
arm group label: Pressure-controlled ventilation
arm group type: Active Comparator
description: During cardiopulmonary bypass period the patients were ventilated with pressure-controlled ventilation
arm group label: No ventilation
arm group type: No Intervention
description: During cardiopulmonary bypass period the patients were disconnected from ventilator
intervention type: Device
intervention name: Volume controlled ventilation
description: Changing modes of ventilation during cardiopulmonary bypass
arm group label: Volume-controlled ventilation
intervention type: Device
intervention name: Pressure controlled ventilation
description: Applying pressure controlled ventilation during cardiopulmonary bypass Period
arm group label: Pressure-controlled ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ayman Anis Metry
investigator title: Assistant professor
sharing ipd: No