<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/NCT03024658</url>
  </required_header>
  <id_info>
    <org_study_id>Saims/IEC/14/02/35</org_study_id>
    <nct_id>NCT03024658</nct_id>
  </id_info>
  <brief_title>Effect of Positive End Expiratory Pressure at the Time of Induction in Morbidly Obese Patients</brief_title>
  <official_title>Single Minute of Positive End Expiratory Pressure at the Time of Induction: Effect on Arterial Blood Gases and Hemodynamics in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sri Aurobindo Institute of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sri Aurobindo Institute of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Positive end expiratory pressure (PEEP) at the time of induction increases&#xD;
      oxygenation by preventing lung atelectasis. However, PEEP may not prove beneficial in all&#xD;
      cases. Factors affecting the action of PEEP have not been elucidated well and remain&#xD;
      controversial. Pulmonary vasculature has direct bearing on the action of PEEP as has been&#xD;
      proven in previous studies. Thus this study was planned to evaluate the action of PEEP on the&#xD;
      basis of pulmonary artery systolic pressure (PASP) which is non invasive and easily measured&#xD;
      by trans-thoracic echocardiography.&#xD;
&#xD;
      Methodology: This Randomized prospective study comprised of 70 morbidly obese patients, ASA&#xD;
      grade II or III, aged 20-65 years with BMI &gt; 40kg/m2, scheduled for elective laparoscopic&#xD;
      bariatric surgery. Ten patients had to be excluded. Thus a total of 60 patients participated&#xD;
      in the study. Thirty patients received no PEEP at the time of induction while other 30&#xD;
      patients were given a PEEP of 10cm of H2O. Serial ABG samples were taken pre operatively, at&#xD;
      the time of intubation, 5 min after intubation and 10 min after intubation. Patients were&#xD;
      then divided into four groups on the basis of PASP value of ≤ 30 mm Hg with and without PEEP&#xD;
      or &gt; 30 mm Hg&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective study was conducted in the Department Of Anaesthesiology&amp; Critical Care, Sri&#xD;
      Aurobindo Institute of Medical Sciences &amp; P.G. Institute and Mohak Hospitals, Indore, over a&#xD;
      period of one year. Seventy morbidly obese patients, ASA grade II or III, aged 20-65 years&#xD;
      with BMI &gt; 40kg/m2, scheduled for elective laparoscopic bariatric surgery were selected and a&#xD;
      written informed consent was obtained. All the recruited patients underwent 2D-trans-thoracic&#xD;
      echocardiography and PASP was recorded. Echocardiography was performed by same cardiologist&#xD;
      as this measurement is operator dependent. Patients who denied consent, those undergoing&#xD;
      Emergency and/or open surgery and those requiring more than 2 attempts for intubation were&#xD;
      excluded.&#xD;
&#xD;
      Arterial line was inserted pre operatively and ABG sample was taken and hemodynamic parameter&#xD;
      recording done while the patient was breathing room air. Both groups were pre-oxygenated for&#xD;
      3 minutes with 100% Oxygen. Standard procedure was used for induction of anesthesia in all&#xD;
      the patients. No premedication was given. All the patients were induced with i.v.&#xD;
      Glycopyrolate (0.005-0.01 mg/kg), i.v. Fentanyl (2µg/kg) and i.v. Propofol. Once the patient&#xD;
      became unresponsive to verbal commands, Succinylcholine was then administered in a dose of 1-&#xD;
      1.5 mg/ kg. Mechanical ventilation was started with 100% oxygen. A PEEP of 10 cm H2O was&#xD;
      applied using four hand technique in Study group while the control group received no PEEP.&#xD;
      After one minute endotracheal intubation was done. PEEP was continued in study group after&#xD;
      intubation.&#xD;
&#xD;
      Arterial blood gas (ABG) analysis and hemodynamic parameters were recorded at following&#xD;
      stages:&#xD;
&#xD;
        1. Just after inflation of cuff of endotracheal tube&#xD;
&#xD;
        2. 5 minutes post intubation&#xD;
&#xD;
        3. 10 minutes post intubation&#xD;
&#xD;
      Patients were then again divided into four groups on the basis of PASP:&#xD;
&#xD;
      Group 1: Patients with PASP ≤ 30 mmHg receiving no PEEP (n= 11) Group 2: PASP ≤ 30 mm Hg&#xD;
      receiving PEEP of 10 cm H2O (n= 11) Group 3: PASP &gt; 30 mm Hg receiving no PEEP (n= 19) Group&#xD;
      4: PASP &gt; 30 mm Hg receiving PEEP of 10 cm H2O (n=19)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Arterial oxygenation (PaO2) in mm Hg recorded preoperatively and taken as baseline value</time_frame>
    <description>Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia</measure>
    <time_frame>Arterial carbon di oxide (PaCO2) in mm Hg was recorded from ABG preoperatively and taken as baseline value</time_frame>
    <description>Arterial carbon di oxide (PaCO2) values in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia</measure>
    <time_frame>Pulse Rate (beats/ min) was recorded from ABG preoperatively and taken as baseline value</time_frame>
    <description>Pulse Rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia</measure>
    <time_frame>Systolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value</time_frame>
    <description>Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia</measure>
    <time_frame>Diastolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value</time_frame>
    <description>Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Arterial oxygenation (PaO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube</time_frame>
    <description>Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Arterial carbon di oxide (PaCO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube</time_frame>
    <description>Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Pulse rate (beats/ min) was recorded just after the placement and cuff inflation of endotracheal tube</time_frame>
    <description>Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Systolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube</time_frame>
    <description>Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Diastolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube</time_frame>
    <description>Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Arterial oxygenation (PaO2) in mm Hg was recorded five minutes post intubation</time_frame>
    <description>Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Arterial carbon di oxide (PaCO2) in mm Hg was recorded five minutes post intubation</time_frame>
    <description>Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Pulse rate (beats/ min) was recorded five minutes post intubation</time_frame>
    <description>Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Systolic BP in mm Hg was recorded five minutes post intubation</time_frame>
    <description>Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Diastolic BP in mm Hg was recorded five minutes post intubation</time_frame>
    <description>Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Arterial oxygenation (PaO2) in mm Hg was recorded ten minutes post intubation</time_frame>
    <description>Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Arterial carbon di oxide (PaCO2) in mm Hg was recorded ten minutes post intubation</time_frame>
    <description>Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>pulse Rate (beats/ min) was recorded ten minutes post intubation</time_frame>
    <description>Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Systolic BP in mm Hg was recorded ten minutes post intubation</time_frame>
    <description>Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction</measure>
    <time_frame>Diastolic BP in mm Hg was recorded ten minutes post intubation</time_frame>
    <description>Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value</time_frame>
    <description>Preoperative arterial oxygenation was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value</time_frame>
    <description>Preoperative arterial carbon di oxide was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value</time_frame>
    <description>Preoperative pulse rate was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value</time_frame>
    <description>Systolic blood pressure was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value</time_frame>
    <description>Diastolic blood pressure was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube</time_frame>
    <description>Arterial oxygenation recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube</time_frame>
    <description>Arterial carbon di oxide (mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube</time_frame>
    <description>Pulse rate (beats/ min) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameters was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube</time_frame>
    <description>Systolic pressure(mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube</time_frame>
    <description>Diastolic blood pressure(mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded five minutes post intubation</time_frame>
    <description>Arterial oxygenation recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded five minutes post intubation</time_frame>
    <description>Arterial carbon di oxide (mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded five minutes post intubation</time_frame>
    <description>Pulse rate (beats/ min) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded five minutes post intubation</time_frame>
    <description>Systolic pressure(mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded five minutes post intubation</time_frame>
    <description>Diastolic blood pressure(mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded ten minutes post intubation</time_frame>
    <description>Arterial oxygenation (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded ten minutes post intubation</time_frame>
    <description>Arterial carbon di oxide (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded ten minutes post intubation</time_frame>
    <description>Pulse rate (beats/ min) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded ten minutes post intubation</time_frame>
    <description>Systolic blood pressure (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters</measure>
    <time_frame>ABG and hemodynamic parameters were recorded ten minutes post intubation</time_frame>
    <description>Diastolic blood pressure(mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP &gt; 30 mm Hg receiving PEEP with those not receiving any PEEP</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>Zero PEEP</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group of patients did not receive any PEEP at the time of induction of general anesthesia (n= 30)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEEP- 10 cm of H2O</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group comprised of patients who received a PEEP of 10 cm H2O at the time of induction of general anesthesia (n= 30)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>positive end expiratory pressure (PEEP)</intervention_name>
    <description>Positive end expiratory pressure was applied using anesthesia machine at the time of induction in the patients undergoing laparoscopic bariatric surgery</description>
    <arm_group_label>PEEP- 10 cm of H2O</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Patients recruited were&#xD;
&#xD;
          -  Anesthesia society of Anesthesiologist (ASA) physical status l, II or III,&#xD;
&#xD;
          -  Aged 20-65 years&#xD;
&#xD;
          -  BMI &gt; 40kg/m2&#xD;
&#xD;
          -  scheduled for elective laparoscopic bariatric surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who denied consent&#xD;
&#xD;
          -  Did not fulfill the inclusion criteria,&#xD;
&#xD;
          -  patients undergoing Emergency and/or open surgery&#xD;
&#xD;
          -  Patients requiring more than 2 attempts for intubation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.</citation>
    <PMID>19809292</PMID>
  </reference>
  <results_reference>
    <citation>Pelosi P, Croci M, Ravagnan I, Cerisara M, Vicardi P, Lissoni A, Gattinoni L. Respiratory system mechanics in sedated, paralyzed, morbidly obese patients. J Appl Physiol (1985). 1997 Mar;82(3):811-8. doi: 10.1152/jappl.1997.82.3.811.</citation>
    <PMID>9074968</PMID>
  </results_reference>
  <results_reference>
    <citation>Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060.</citation>
    <PMID>12456460</PMID>
  </results_reference>
  <results_reference>
    <citation>Coussa M, Proietti S, Schnyder P, Frascarolo P, Suter M, Spahn DR, Magnusson L. Prevention of atelectasis formation during the induction of general anesthesia in morbidly obese patients. Anesth Analg. 2004 May;98(5):1491-5, table of contents. doi: 10.1213/01.ane.0000111743.61132.99.</citation>
    <PMID>15105237</PMID>
  </results_reference>
  <results_reference>
    <citation>Almarakbi WA, Fawzi HM, Alhashemi JA. Effects of four intraoperative ventilatory strategies on respiratory compliance and gas exchange during laparoscopic gastric banding in obese patients. Br J Anaesth. 2009 Jun;102(6):862-8. doi: 10.1093/bja/aep084. Epub 2009 Apr 29.</citation>
    <PMID>19403595</PMID>
  </results_reference>
  <results_reference>
    <citation>Pelosi P, Goldner M, McKibben A, Adams A, Eccher G, Caironi P, Losappio S, Gattinoni L, Marini JJ. Recruitment and derecruitment during acute respiratory failure: an experimental study. Am J Respir Crit Care Med. 2001 Jul 1;164(1):122-30. doi: 10.1164/ajrccm.164.1.2007010.</citation>
    <PMID>11435250</PMID>
  </results_reference>
  <results_reference>
    <citation>Luecke T, Roth H, Joachim A, Herrmann P, Deventer B, Weisser G, Pelosi P, Quintel M. Effects of end-inspiratory and end-expiratory pressures on alveolar recruitment and derecruitment in saline-washout-induced lung injury -- a computed tomography study. Acta Anaesthesiol Scand. 2004 Jan;48(1):82-92. doi: 10.1111/j.1399-6576.2004.00265.x.</citation>
    <PMID>14674978</PMID>
  </results_reference>
  <results_reference>
    <citation>Gattinoni L, Pesenti A, Bombino M, Baglioni S, Rivolta M, Rossi F, Rossi G, Fumagalli R, Marcolin R, Mascheroni D, et al. Relationships between lung computed tomographic density, gas exchange, and PEEP in acute respiratory failure. Anesthesiology. 1988 Dec;69(6):824-32. doi: 10.1097/00000542-198812000-00005.</citation>
    <PMID>3057937</PMID>
  </results_reference>
  <results_reference>
    <citation>Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801. doi: 10.1164/ajrccm.164.5.2006071.</citation>
    <PMID>11549535</PMID>
  </results_reference>
  <results_reference>
    <citation>Gattinoni L, Pesenti A, Baglioni S, Vitale G, Rivolta M, Pelosi P. Inflammatory pulmonary edema and positive end-expiratory pressure: correlations between imaging and physiologic studies. J Thorac Imaging. 1988 Jul;3(3):59-64. doi: 10.1097/00005382-198807000-00013.</citation>
    <PMID>3292784</PMID>
  </results_reference>
  <results_reference>
    <citation>Fougeres E, Teboul JL, Richard C, Osman D, Chemla D, Monnet X. Hemodynamic impact of a positive end-expiratory pressure setting in acute respiratory distress syndrome: importance of the volume status. Crit Care Med. 2010 Mar;38(3):802-7. doi: 10.1097/CCM.0b013e3181c587fd.</citation>
    <PMID>19926983</PMID>
  </results_reference>
  <results_reference>
    <citation>McQuillan BM, Picard MH, Leavitt M, Weyman AE. Clinical correlates and reference intervals for pulmonary artery systolic pressure among echocardiographically normal subjects. Circulation. 2001 Dec 4;104(23):2797-802. doi: 10.1161/hc4801.100076.</citation>
    <PMID>11733397</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 14, 2017</last_update_submitted>
  <last_update_submitted_qc>January 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sri Aurobindo Institute of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Dr. Dipti Saxena</investigator_full_name>
    <investigator_title>Associate Professor, Anaesthesiology</investigator_title>
  </responsible_party>
  <keyword>Pulmonary artery systolic pressure</keyword>
  <keyword>Positive end expiratory pressure</keyword>
  <keyword>morbidly obese</keyword>
  <keyword>laparoscopic bariatric surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>data was recorded on a planned proforma. Masterchart was prepared on completion which is available for sharing.</ipd_description>
  </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/NCT03024658
org study id: Saims/IEC/14/02/35
nct id: NCT03024658
lead sponsor: 
has dmc: No
Background: Positive end expiratory pressure (PEEP) at the time of induction increases
      oxygenation by preventing lung atelectasis. However, PEEP may not prove beneficial in all
      cases. Factors affecting the action of PEEP have not been elucidated well and remain
      controversial. Pulmonary vasculature has direct bearing on the action of PEEP as has been
      proven in previous studies. Thus this study was planned to evaluate the action of PEEP on the
      basis of pulmonary artery systolic pressure (PASP) which is non invasive and easily measured
      by trans-thoracic echocardiography.

      Methodology: This Randomized prospective study comprised of 70 morbidly obese patients, ASA
      grade II or III, aged 20-65 years with BMI > 40kg/m2, scheduled for elective laparoscopic
      bariatric surgery. Ten patients had to be excluded. Thus a total of 60 patients participated
      in the study. Thirty patients received no PEEP at the time of induction while other 30
      patients were given a PEEP of 10cm of H2O. Serial ABG samples were taken pre operatively, at
      the time of intubation, 5 min after intubation and 10 min after intubation. Patients were
      then divided into four groups on the basis of PASP value of ≤ 30 mm Hg with and without PEEP
      or > 30 mm Hg
This prospective study was conducted in the Department Of Anaesthesiology& Critical Care, Sri
      Aurobindo Institute of Medical Sciences & P.G. Institute and Mohak Hospitals, Indore, over a
      period of one year. Seventy morbidly obese patients, ASA grade II or III, aged 20-65 years
      with BMI > 40kg/m2, scheduled for elective laparoscopic bariatric surgery were selected and a
      written informed consent was obtained. All the recruited patients underwent 2D-trans-thoracic
      echocardiography and PASP was recorded. Echocardiography was performed by same cardiologist
      as this measurement is operator dependent. Patients who denied consent, those undergoing
      Emergency and/or open surgery and those requiring more than 2 attempts for intubation were
      excluded.

      Arterial line was inserted pre operatively and ABG sample was taken and hemodynamic parameter
      recording done while the patient was breathing room air. Both groups were pre-oxygenated for
      3 minutes with 100% Oxygen. Standard procedure was used for induction of anesthesia in all
      the patients. No premedication was given. All the patients were induced with i.v.
      Glycopyrolate (0.005-0.01 mg/kg), i.v. Fentanyl (2µg/kg) and i.v. Propofol. Once the patient
      became unresponsive to verbal commands, Succinylcholine was then administered in a dose of 1-
      1.5 mg/ kg. Mechanical ventilation was started with 100% oxygen. A PEEP of 10 cm H2O was
      applied using four hand technique in Study group while the control group received no PEEP.
      After one minute endotracheal intubation was done. PEEP was continued in study group after
      intubation.

      Arterial blood gas (ABG) analysis and hemodynamic parameters were recorded at following
      stages:

        1. Just after inflation of cuff of endotracheal tube

        2. 5 minutes post intubation

        3. 10 minutes post intubation

      Patients were then again divided into four groups on the basis of PASP:

      Group 1: Patients with PASP ≤ 30 mmHg receiving no PEEP (n= 11) Group 2: PASP ≤ 30 mm Hg
      receiving PEEP of 10 cm H2O (n= 11) Group 3: PASP > 30 mm Hg receiving no PEEP (n= 19) Group
      4: PASP > 30 mm Hg receiving PEEP of 10 cm H2O (n=19)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Arterial oxygenation (PaO2) in mm Hg recorded preoperatively and taken as baseline value
description: Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia
time frame: Arterial carbon di oxide (PaCO2) in mm Hg was recorded from ABG preoperatively and taken as baseline value
description: Arterial carbon di oxide (PaCO2) values in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia
time frame: Pulse Rate (beats/ min) was recorded from ABG preoperatively and taken as baseline value
description: Pulse Rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia
time frame: Systolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value
description: Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction of general anesthesia
time frame: Diastolic BP in mm Hg was recorded from ABG preoperatively and taken as baseline value
description: Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP preoperatively just before taking the patient in operation theater
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Arterial oxygenation (PaO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube
description: Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Arterial carbon di oxide (PaCO2) in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube
description: Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Pulse rate (beats/ min) was recorded just after the placement and cuff inflation of endotracheal tube
description: Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Systolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube
description: Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Diastolic BP in mm Hg was recorded just after the placement and cuff inflation of endotracheal tube
description: Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP just after the placement and cuff inflation of endotracheal tube
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Arterial oxygenation (PaO2) in mm Hg was recorded five minutes post intubation
description: Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Arterial carbon di oxide (PaCO2) in mm Hg was recorded five minutes post intubation
description: Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Pulse rate (beats/ min) was recorded five minutes post intubation
description: Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Systolic BP in mm Hg was recorded five minutes post intubation
description: Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Diastolic BP in mm Hg was recorded five minutes post intubation
description: Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP five minutes after intubation
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Arterial oxygenation (PaO2) in mm Hg was recorded ten minutes post intubation
description: Arterial oxygenation (PaO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Arterial carbon di oxide (PaCO2) in mm Hg was recorded ten minutes post intubation
description: Arterial carbon di oxide (PaCO2) in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: pulse Rate (beats/ min) was recorded ten minutes post intubation
description: Pulse rate (beats/ min) was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Systolic BP in mm Hg was recorded ten minutes post intubation
description: Systolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
measure: effect of PEEP of 10 cm H2O on arterial blood gases and hemodynamic parameters, when applied at the time of induction
time frame: Diastolic BP in mm Hg was recorded ten minutes post intubation
description: Diastolic BP in mm Hg was recorded and compared between group receiving PEEP and group not receiving PEEP ten minutes after intubation
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
description: Preoperative arterial oxygenation was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
description: Preoperative arterial carbon di oxide was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
description: Preoperative pulse rate was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
description: Systolic blood pressure was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded preoperatively and taken as baseline value
description: Diastolic blood pressure was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
description: Arterial oxygenation recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
description: Arterial carbon di oxide (mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
description: Pulse rate (beats/ min) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameters was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
description: Systolic pressure(mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded just after the placement and cuff inflation of endotracheal tube
description: Diastolic blood pressure(mm Hg) recorded just after the placement and cuff inflation of endotracheal tube, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded five minutes post intubation
description: Arterial oxygenation recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded five minutes post intubation
description: Arterial carbon di oxide (mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded five minutes post intubation
description: Pulse rate (beats/ min) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded five minutes post intubation
description: Systolic pressure(mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded five minutes post intubation
description: Diastolic blood pressure(mm Hg) recorded five minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation
description: Arterial oxygenation (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation
description: Arterial carbon di oxide (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation
description: Pulse rate (beats/ min) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation
description: Systolic blood pressure (mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
measure: Effect of pulmonary artery systolic pressure (PASP) on the efficacy of PEEP as reflected by changes in ABG and hemodynamic parameters
time frame: ABG and hemodynamic parameters were recorded ten minutes post intubation
description: Diastolic blood pressure(mm Hg) recorded ten minutes after intubation, was compared of those patients who received PEEP and had PASP ≤ 30 mm Hg with those patients who did not receive PEEP and had PASP ≤ 30 mm Hg. Similarly the above parameter was compared in patients with PASP > 30 mm Hg receiving PEEP with those not receiving any PEEP
arm group label: Zero PEEP
arm group type: No Intervention
description: This group of patients did not receive any PEEP at the time of induction of general anesthesia (n= 30)
arm group label: PEEP- 10 cm of H2O
arm group type: Experimental
description: This group comprised of patients who received a PEEP of 10 cm H2O at the time of induction of general anesthesia (n= 30)
intervention type: Other
intervention name: positive end expiratory pressure (PEEP)
description: Positive end expiratory pressure was applied using anesthesia machine at the time of induction in the patients undergoing laparoscopic bariatric surgery
arm group label: PEEP- 10 cm of H2O
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
citation: Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.
PMID: 19809292
citation: Pelosi P, Croci M, Ravagnan I, Cerisara M, Vicardi P, Lissoni A, Gattinoni L. Respiratory system mechanics in sedated, paralyzed, morbidly obese patients. J Appl Physiol (1985). 1997 Mar;82(3):811-8. doi: 10.1152/jappl.1997.82.3.811.
PMID: 9074968
citation: Eichenberger A, Proietti S, Wicky S, Frascarolo P, Suter M, Spahn DR, Magnusson L. Morbid obesity and postoperative pulmonary atelectasis: an underestimated problem. Anesth Analg. 2002 Dec;95(6):1788-92, table of contents. doi: 10.1097/00000539-200212000-00060.
PMID: 12456460
citation: Coussa M, Proietti S, Schnyder P, Frascarolo P, Suter M, Spahn DR, Magnusson L. Prevention of atelectasis formation during the induction of general anesthesia in morbidly obese patients. Anesth Analg. 2004 May;98(5):1491-5, table of contents. doi: 10.1213/01.ane.0000111743.61132.99.
PMID: 15105237
citation: Almarakbi WA, Fawzi HM, Alhashemi JA. Effects of four intraoperative ventilatory strategies on respiratory compliance and gas exchange during laparoscopic gastric banding in obese patients. Br J Anaesth. 2009 Jun;102(6):862-8. doi: 10.1093/bja/aep084. Epub 2009 Apr 29.
PMID: 19403595
citation: Pelosi P, Goldner M, McKibben A, Adams A, Eccher G, Caironi P, Losappio S, Gattinoni L, Marini JJ. Recruitment and derecruitment during acute respiratory failure: an experimental study. Am J Respir Crit Care Med. 2001 Jul 1;164(1):122-30. doi: 10.1164/ajrccm.164.1.2007010.
PMID: 11435250
citation: Luecke T, Roth H, Joachim A, Herrmann P, Deventer B, Weisser G, Pelosi P, Quintel M. Effects of end-inspiratory and end-expiratory pressures on alveolar recruitment and derecruitment in saline-washout-induced lung injury -- a computed tomography study. Acta Anaesthesiol Scand. 2004 Jan;48(1):82-92. doi: 10.1111/j.1399-6576.2004.00265.x.
PMID: 14674978
citation: Gattinoni L, Pesenti A, Bombino M, Baglioni S, Rivolta M, Rossi F, Rossi G, Fumagalli R, Marcolin R, Mascheroni D, et al. Relationships between lung computed tomographic density, gas exchange, and PEEP in acute respiratory failure. Anesthesiology. 1988 Dec;69(6):824-32. doi: 10.1097/00000542-198812000-00005.
PMID: 3057937
citation: Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795-801. doi: 10.1164/ajrccm.164.5.2006071.
PMID: 11549535
citation: Gattinoni L, Pesenti A, Baglioni S, Vitale G, Rivolta M, Pelosi P. Inflammatory pulmonary edema and positive end-expiratory pressure: correlations between imaging and physiologic studies. J Thorac Imaging. 1988 Jul;3(3):59-64. doi: 10.1097/00005382-198807000-00013.
PMID: 3292784
citation: Fougeres E, Teboul JL, Richard C, Osman D, Chemla D, Monnet X. Hemodynamic impact of a positive end-expiratory pressure setting in acute respiratory distress syndrome: importance of the volume status. Crit Care Med. 2010 Mar;38(3):802-7. doi: 10.1097/CCM.0b013e3181c587fd.
PMID: 19926983
citation: McQuillan BM, Picard MH, Leavitt M, Weyman AE. Clinical correlates and reference intervals for pulmonary artery systolic pressure among echocardiographically normal subjects. Circulation. 2001 Dec 4;104(23):2797-802. doi: 10.1161/hc4801.100076.
PMID: 11733397
responsible party type: Principal Investigator
investigator affiliation: Sri Aurobindo Institute of Medical Sciences
investigator full name: Dr. Dipti Saxena
investigator title: Associate Professor, Anaesthesiology
mesh term: Obesity, Morbid
sharing ipd: Yes
ipd description: data was recorded on a planned proforma. Masterchart was prepared on completion which is available for sharing.