<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/NCT03023670</url>
  </required_header>
  <id_info>
    <org_study_id>IRB0000871180</org_study_id>
    <nct_id>NCT03023670</nct_id>
  </id_info>
  <brief_title>Lung Protection and Pediatric Cardiac Surgery</brief_title>
  <official_title>Ventilatory Patterns During Cardiopulmonary Bypass In Pediatric Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung&#xD;
      perfusion is maintained solely by the bronchial arterial system&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be performed in the pediatric cardiothoracic unit, pediatric Assiut University&#xD;
      Hospital. After obtaining approval from the local ethics committee and written informed&#xD;
      parents consent 60 patients will be included in this study according to the following&#xD;
      criteria:&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">March 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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative</measure>
    <time_frame>preoperative and within the first 7 days postoperative</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation</measure>
    <time_frame>Within the first 7 days postoperative</time_frame>
    <description>Duration of mechanical ventilation (hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care unit stay</measure>
    <time_frame>Within the first 7 days postoperative</time_frame>
    <description>Intensive care unit stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubation time</measure>
    <time_frame>Within the first 7 days postoperative</time_frame>
    <description>Intubation time (hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial blood gases</measure>
    <time_frame>Within the first 7 days postoperative</time_frame>
    <description>Intraoperative and postoperative by appropriate scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Lung Injury, Acute</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive low rate (4\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cardiopulmonary bypass</intervention_name>
    <description>Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass</description>
    <arm_group_label>Group A</arm_group_label>
    <other_name>Control group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cardiopulmonary bypass</intervention_name>
    <description>Low rate (4\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.</description>
    <arm_group_label>Group B</arm_group_label>
    <other_name>Low frequency group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective cardiac surgery&#xD;
&#xD;
          -  Ventricular septal defect (VSD).&#xD;
&#xD;
          -  Atrial septal defect (ASD)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cyanotic heart disease.&#xD;
&#xD;
          -  Patients with preoperative chest problems.&#xD;
&#xD;
          -  Patients with known renal or hepatic dysfunctions.&#xD;
&#xD;
          -  Planned off-pump cardiac surgery.&#xD;
&#xD;
          -  Emergency cardiac surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sayed Abd-Elshafy, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Associate profossor of Anesthesiology and critical care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>December 2, 2018</last_update_submitted>
  <last_update_submitted_qc>December 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Sayed Kaoud Abd-Elshafy</investigator_full_name>
    <investigator_title>Associate profossor of anesthesiology and critical care</investigator_title>
  </responsible_party>
  <keyword>Lung</keyword>
  <keyword>Cardiopulmonary Bypass</keyword>
  <keyword>Pediatric</keyword>
  <keyword>Cardiac surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Injury</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
  </condition_browse>
  <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/NCT03023670
org study id: IRB0000871180
nct id: NCT03023670
lead sponsor: 
has dmc: Yes
The lung is at risk for ischemic insults during total cardiopulmonary bypass because lung
      perfusion is maintained solely by the bronchial arterial system
The study will be performed in the pediatric cardiothoracic unit, pediatric Assiut University
      Hospital. After obtaining approval from the local ethics committee and written informed
      parents consent 60 patients will be included in this study according to the following
      criteria:
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Change from Baseline Computerized tomography chest (CT chest) within 7 days postoperative
time frame: preoperative and within the first 7 days postoperative
measure: Mechanical ventilation
time frame: Within the first 7 days postoperative
description: Duration of mechanical ventilation (hours)
measure: Intensive care unit stay
time frame: Within the first 7 days postoperative
description: Intensive care unit stay
measure: Intubation time
time frame: Within the first 7 days postoperative
description: Intubation time (hours)
measure: Arterial blood gases
time frame: Within the first 7 days postoperative
description: Intraoperative and postoperative by appropriate scale
arm group label: Group A
arm group type: Active Comparator
description: This group will include patients with low flow of mixed oxygen / air (1:1L) during the period of cardiopulmonary bypass
arm group label: Group B
arm group type: Active Comparator
description: This group will receive low rate (4\min) with low tidal volume ( 2ml/kg ) during the period of cardiopulmonary bypass.
intervention type: Procedure
intervention name: cardiopulmonary bypass
description: Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass
arm group label: Group A
other name: Control group
intervention type: Procedure
intervention name: cardiopulmonary bypass
description: Low rate (4\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.
arm group label: Group B
other name: Low frequency group
criteria: 
gender: All
minimum age: 2 Years
maximum age: 10 Years
healthy volunteers: No
last name: Sayed Abd-Elshafy, M.D
role: Principal Investigator
affiliation: Associate profossor of Anesthesiology and critical care
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Sayed Kaoud Abd-Elshafy
investigator title: Associate profossor of anesthesiology and critical care
mesh term: Lung Injury
mesh term: Acute Lung Injury
sharing ipd: Undecided