<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/NCT03758937</url>
  </required_header>
  <id_info>
    <org_study_id>AntalyaTRH31</org_study_id>
    <nct_id>NCT03758937</nct_id>
  </id_info>
  <brief_title>Comparison of Volume Controlled Ventilation and Pressure Controlled Ventilation in Laparoscopic Bariatric Surgery</brief_title>
  <official_title>Comparison of Volume Controlled Ventilation and Pressure Controlled Ventilation in Terms of Respiratory Mechanics in Laparoscopic Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Antalya Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Antalya Training and Research Hospital</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 volume controlled-ventilation (VCV) and&#xD;
      pressure-controlled ventilation (PCV) in terms of pulmonary gas exchange, respiratory&#xD;
      mechanics and arterial blood gas values in patients undergoing laparoscopic bariatric&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Today, morbid obesity has become a global problem. It is not clear which mechanical&#xD;
      ventilation mode will be used in bariatric surgery, which is one of the treatment options of&#xD;
      these patients. VCV is the most commonly used mode to ventilate anesthetized patients.&#xD;
      However, especially in obese patients, high airway pressures and hypoxia may occur due to&#xD;
      increased intrapulmonary shunts. Therefore, we aimed to investigate the potential of PCV&#xD;
      strategy to improve pulmonary gas exchange, respiratory mechanics and arterial blood gas&#xD;
      values according to VCV in patients undergoing bariatric surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">April 1, 2017</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Partial oxygen pressure</measure>
    <time_frame>5 minutes after induction</time_frame>
    <description>Assessed 5 minutes after induction by using arterial blood gas analysis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Partial oxygen pressure</measure>
    <time_frame>30 minutes after pneumoperitoneum</time_frame>
    <description>Assessed 30 minutes after pneumoperitoneum by using arterial blood gas</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Partial oxygen pressure</measure>
    <time_frame>through surgery completion, an average of 90 minutes</time_frame>
    <description>Assessed through surgery completion, an average of 90 minutes by using arterial blood gas</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Partial carbon dioxide pressure</measure>
    <time_frame>5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes</time_frame>
    <description>Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using arterial blood gas analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial carbon dioxide pressure - end-tidal carbon dioxide pressure</measure>
    <time_frame>5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes</time_frame>
    <description>Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using arterial blood gas analysis and end-tidal monitor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak airway pressure</measure>
    <time_frame>5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes</time_frame>
    <description>Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using the patient monitor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic compliance</measure>
    <time_frame>5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes</time_frame>
    <description>Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using formula (Tidal volume/peak airway pressure - Positive end-expiratory pressure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inspired oxygen pressure / Fractional oxygen ratio</measure>
    <time_frame>5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes</time_frame>
    <description>Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alveolar-arterial oxygen gradient pressure</measure>
    <time_frame>5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes</time_frame>
    <description>Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using formula (D(A-a) O2).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Bariatric Surgery</condition>
  <arm_group>
    <arm_group_label>volume-controlled ventilation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the operation, necessary interventions were made by following the algorithm. Hemodynamic and mechanical ventilation parameters of patients were recorded 5 minutes after induction, 30 minutes after pneumoperitoneum and at the end of surgery and were performed arterial blood gas analysis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pressure-controlled ventilation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During the operation, necessary interventions were made by following the algorithm. Hemodynamic and mechanical ventilation parameters of patients were recorded 5 minutes after induction, 30 minutes after pneumoperitoneum and at the end of surgery and were performed arterial blood gas analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>volume-controlled ventilation</intervention_name>
    <arm_group_label>volume-controlled ventilation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pressure-controlled ventilation</intervention_name>
    <arm_group_label>pressure-controlled ventilation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or above,&#xD;
&#xD;
          -  ASA II patients&#xD;
&#xD;
          -  BMI &gt; 40 kg / m2&#xD;
&#xD;
          -  No serious comorbidity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable patients during the operation&#xD;
&#xD;
          -  The requirement for mechanical ventilation in the postoperative period.&#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>Erhan Ozyurt, MD</last_name>
    <role>Study Director</role>
    <affiliation>Antalya Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Antalya Traning and Research Hospital</name>
      <address>
        <city>Antalya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bariatric surgery</keyword>
  <keyword>volume-controlled ventilation</keyword>
  <keyword>pressure-controlled ventilation</keyword>
  <!-- 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/NCT03758937
org study id: AntalyaTRH31
nct id: NCT03758937
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare volume controlled-ventilation (VCV) and
      pressure-controlled ventilation (PCV) in terms of pulmonary gas exchange, respiratory
      mechanics and arterial blood gas values in patients undergoing laparoscopic bariatric
      surgery.
Today, morbid obesity has become a global problem. It is not clear which mechanical
      ventilation mode will be used in bariatric surgery, which is one of the treatment options of
      these patients. VCV is the most commonly used mode to ventilate anesthetized patients.
      However, especially in obese patients, high airway pressures and hypoxia may occur due to
      increased intrapulmonary shunts. Therefore, we aimed to investigate the potential of PCV
      strategy to improve pulmonary gas exchange, respiratory mechanics and arterial blood gas
      values according to VCV in patients undergoing bariatric surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Partial oxygen pressure
time frame: 5 minutes after induction
description: Assessed 5 minutes after induction by using arterial blood gas analysis.
measure: Partial oxygen pressure
time frame: 30 minutes after pneumoperitoneum
description: Assessed 30 minutes after pneumoperitoneum by using arterial blood gas
measure: Partial oxygen pressure
time frame: through surgery completion, an average of 90 minutes
description: Assessed through surgery completion, an average of 90 minutes by using arterial blood gas
measure: Partial carbon dioxide pressure
time frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
description: Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using arterial blood gas analysis.
measure: Partial carbon dioxide pressure - end-tidal carbon dioxide pressure
time frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
description: Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using arterial blood gas analysis and end-tidal monitor.
measure: Peak airway pressure
time frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
description: Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using the patient monitor.
measure: Dynamic compliance
time frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
description: Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using formula (Tidal volume/peak airway pressure - Positive end-expiratory pressure)
measure: Inspired oxygen pressure / Fractional oxygen ratio
time frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
description: Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes
measure: Alveolar-arterial oxygen gradient pressure
time frame: 5 minutes after induction, 30 minutes after pneumoperitoneum, through surgery completion, an average of 90 minutes
description: Assessed 5 minutes after induction, 30 minutes after pneumoperitoneum and through surgery completion, an average of 90 minutes by using formula (D(A-a) O2).
arm group label: volume-controlled ventilation group
arm group type: Active Comparator
description: During the operation, necessary interventions were made by following the algorithm. Hemodynamic and mechanical ventilation parameters of patients were recorded 5 minutes after induction, 30 minutes after pneumoperitoneum and at the end of surgery and were performed arterial blood gas analysis.
arm group label: pressure-controlled ventilation group
arm group type: Active Comparator
description: During the operation, necessary interventions were made by following the algorithm. Hemodynamic and mechanical ventilation parameters of patients were recorded 5 minutes after induction, 30 minutes after pneumoperitoneum and at the end of surgery and were performed arterial blood gas analysis.
intervention type: Procedure
intervention name: volume-controlled ventilation
arm group label: volume-controlled ventilation group
intervention type: Procedure
intervention name: pressure-controlled ventilation
arm group label: pressure-controlled ventilation group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erhan Ozyurt, MD
role: Study Director
affiliation: Antalya Training and Research Hospital
facility: 
country: Turkey
responsible party type: Sponsor