<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/NCT04506736</url>
  </required_header>
  <id_info>
    <org_study_id>6204</org_study_id>
    <nct_id>NCT04506736</nct_id>
  </id_info>
  <brief_title>Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery</brief_title>
  <official_title>Open Lung Approach Versus Conventional Protective Ventilation in Obese Patients Undergoing Open Abdominal Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig 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>
      the purpose of this study is to compare open lung approach versus conventional protective&#xD;
      ventilation in obese patients undergoing open abdominal surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      after being informed about the study and potential risks. All patients giving written consent&#xD;
      will be randomized by double blind manner into 2 groups each one containing 24 patients Group&#xD;
      SPV: will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with&#xD;
      addition of 5 cm H₂O fixed PEEP till the end of the surgery .&#xD;
&#xD;
      Group OLA: The patients will undergo ARM followed by personalized PEEP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Actual">April 30, 2022</completion_date>
  <primary_completion_date type="Actual">March 30, 2022</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>Participant, Care Provider</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>post-operative pulmonary complications</measure>
    <time_frame>one week postoperative</time_frame>
    <description>Pulmonary function tests will be done before surgery as a baseline then repeated after the surgery when the patient is fully awake using bedside spirometer in the sitting position.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>Baseline (before surgery) and intraoperative</time_frame>
    <description>hemodynamic changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>airway pressure</measure>
    <time_frame>intraoperative</time_frame>
    <description>During mechanical ventilation airway pressures will be continuously monitored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pulmonary complications.</measure>
    <time_frame>one week postoperative</time_frame>
    <description>1. Postoperative pulmonary complications which are defined as having one or more of the following: 1.Pneumonia 2. Respiratory failure requiring mechanical ventilation (Postoperative PaO2 &lt; 60 mm Hg on room air, a PaO2:FiO2 ratio &lt; 300 mm Hg) or peripheral oxygen saturation (SpO₂) &lt;90% and requiring oxygen therapy ). 3. Atelectasis requiring bronchoscopic intervention 4. Pulmonary edema ( postoperative acute lung injury or ARDS). 5. Delayed tracheal extubation ( &gt;24 hours postoperatively) or need for reintubation (because of respiratory distress, hypoxia, hypercarbia, or respiratory acidosis). 6. Pneumothorax 7. Bronchospasm (Newly detected refractory expiratory wheeze requiring bronchodilators</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length of hospital stay,</measure>
    <time_frame>postoperative up to one month</time_frame>
    <description>the length of hospital stay, and 30 days mortality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean arterial blood pressure</measure>
    <time_frame>Baseline (before surgery) and intraoperative</time_frame>
    <description>hemodynamic changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ETCO2</measure>
    <time_frame>Baseline (before surgery) and intraoperative</time_frame>
    <description>hemodynamic changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tidal volume</measure>
    <time_frame>intraoperative</time_frame>
    <description>During mechanical ventilation tidal volume will be continuously monitored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SpO2</measure>
    <time_frame>Baseline (before surgery) and intraoperative</time_frame>
    <description>hemodynamic changes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Abdominal Surgery</condition>
  <condition>Obese Patients</condition>
  <arm_group>
    <arm_group_label>SPV spontanous ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OLA open lung ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will undergo ARM followed by personalized PEEP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ARM</intervention_name>
    <description>The ARM is performed by setting the peak inspiratory pressure to 45 cmH₂O then changing the mode of ventilation to pressure controlled ventilation (PCV) with the inspiratory pressure set to give a tidal volume equal to that given during VCV, I:E ratio of 1:1 and a PEEP of 5 cmH₂O. The PEEP level is then increased in 5 cmH₂O steps every minute till it reaches 20 cmH₂O and inspiratory pressure is increased to get an airway opening pressure (inspiratory pressure + PEEP) of 40 cmH₂O which is maintained for one minute after which the ventilation returned to the original setting except for the PEEP level which is kept at 20 cmH₂O.&#xD;
The titration of individualized PEEP is done by decremental reduction of the 20 cmH₂O PEEP level in 2 cmH₂O steps every 2 minutes and measuring static compliance of the respiratory system (CRS) at each step.</description>
    <arm_group_label>OLA open lung ventilation</arm_group_label>
    <other_name>followed by personalized PEEP.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>spontanous ventilation</intervention_name>
    <description>volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .</description>
    <arm_group_label>SPV spontanous ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged between 18 - 65 years&#xD;
&#xD;
          -  BMI between 30-40 kg/m²&#xD;
&#xD;
          -  ASA I and II,open elective abdominal surgery which is expected to last for more than 2&#xD;
             hours under general anesthesia and planned to be extubated at the end of surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery, pregnancy, chronic obstructive pulmonary disease (FEV1 &lt; 80% of the&#xD;
             predicted value)&#xD;
&#xD;
          -  active asthma, acute respiratory distress syndrome&#xD;
&#xD;
          -  history of pneumothorax, lung cyst, Difficult airway, obstructive sleep apnea,ischemic&#xD;
             heart disease, heart failure&#xD;
&#xD;
          -  significant arrhythmias and intracranial hypertension. Exposure to radiotherapy and&#xD;
             chemotherapy within 2 months before surgery. Advanced Cardiovascular ,liver, renal&#xD;
             diseases ischemic heart disease, heart failure, significant arrhythmias and&#xD;
             intracranial hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Howida A kamal, M.D</last_name>
    <role>Study Director</role>
    <affiliation>zagazig U</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Medicine,Zagazig University</name>
      <address>
        <city>Zagazig</city>
        <state>Zagazig, Elsharkia,egypt</state>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>May 23, 2022</last_update_submitted>
  <last_update_submitted_qc>May 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Marwa Mohamed Medhat</investigator_full_name>
    <investigator_title>lecture of anesthesia and surgical intensive care (Principal Investigator)</investigator_title>
  </responsible_party>
  <keyword>Open lung approach</keyword>
  <keyword>conventional ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT04506736
org study id: 6204
nct id: NCT04506736
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
the purpose of this study is to compare open lung approach versus conventional protective
      ventilation in obese patients undergoing open abdominal surgery
after being informed about the study and potential risks. All patients giving written consent
      will be randomized by double blind manner into 2 groups each one containing 24 patients Group
      SPV: will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with
      addition of 5 cm H₂O fixed PEEP till the end of the surgery .

      Group OLA: The patients will undergo ARM followed by personalized PEEP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Care Provider)
masking description: Participant, Care Provider
measure: post-operative pulmonary complications
time frame: one week postoperative
description: Pulmonary function tests will be done before surgery as a baseline then repeated after the surgery when the patient is fully awake using bedside spirometer in the sitting position.
measure: heart rate
time frame: Baseline (before surgery) and intraoperative
description: hemodynamic changes
measure: airway pressure
time frame: intraoperative
description: During mechanical ventilation airway pressures will be continuously monitored.
measure: pulmonary complications.
time frame: one week postoperative
description: 1. Postoperative pulmonary complications which are defined as having one or more of the following: 1.Pneumonia 2. Respiratory failure requiring mechanical ventilation (Postoperative PaO2 < 60 mm Hg on room air, a PaO2:FiO2 ratio < 300 mm Hg) or peripheral oxygen saturation (SpO₂) <90% and requiring oxygen therapy ). 3. Atelectasis requiring bronchoscopic intervention 4. Pulmonary edema ( postoperative acute lung injury or ARDS). 5. Delayed tracheal extubation ( >24 hours postoperatively) or need for reintubation (because of respiratory distress, hypoxia, hypercarbia, or respiratory acidosis). 6. Pneumothorax 7. Bronchospasm (Newly detected refractory expiratory wheeze requiring bronchodilators
measure: length of hospital stay,
time frame: postoperative up to one month
description: the length of hospital stay, and 30 days mortality.
measure: mean arterial blood pressure
time frame: Baseline (before surgery) and intraoperative
description: hemodynamic changes
measure: ETCO2
time frame: Baseline (before surgery) and intraoperative
description: hemodynamic changes
measure: tidal volume
time frame: intraoperative
description: During mechanical ventilation tidal volume will be continuously monitored.
measure: SpO2
time frame: Baseline (before surgery) and intraoperative
description: hemodynamic changes
arm group label: SPV spontanous ventilation
arm group type: Active Comparator
description: The patients will be ventilated using volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .
arm group label: OLA open lung ventilation
arm group type: Active Comparator
description: The patients will undergo ARM followed by personalized PEEP.
intervention type: Other
intervention name: ARM
description: The ARM is performed by setting the peak inspiratory pressure to 45 cmH₂O then changing the mode of ventilation to pressure controlled ventilation (PCV) with the inspiratory pressure set to give a tidal volume equal to that given during VCV, I:E ratio of 1:1 and a PEEP of 5 cmH₂O. The PEEP level is then increased in 5 cmH₂O steps every minute till it reaches 20 cmH₂O and inspiratory pressure is increased to get an airway opening pressure (inspiratory pressure + PEEP) of 40 cmH₂O which is maintained for one minute after which the ventilation returned to the original setting except for the PEEP level which is kept at 20 cmH₂O.
The titration of individualized PEEP is done by decremental reduction of the 20 cmH₂O PEEP level in 2 cmH₂O steps every 2 minutes and measuring static compliance of the respiratory system (CRS) at each step.
arm group label: OLA open lung ventilation
other name: followed by personalized PEEP.
intervention type: Other
intervention name: spontanous ventilation
description: volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .
arm group label: SPV spontanous ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Howida A kamal, M.D
role: Study Director
affiliation: zagazig U
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Marwa Mohamed Medhat
investigator title: lecture of anesthesia and surgical intensive care (Principal Investigator)
mesh term: Obesity