xml: <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/NCT05979129</url>
    </required_header>
    <id_info>
      <org_study_id>MD-65-2022</org_study_id>
      <nct_id>NCT05979129</nct_id>
    </id_info>
    <brief_title>Gastric Insufflation During Facemask Ventilation at Different Levels of End-expiratory Pressure in Obese Patients</brief_title>
    <official_title>Comparing the Incidence of Gastric Insufflation During Facemask Ventilation at Different Levels of End-expiratory Pressure During Induction of Anesthesia in Obese Patients: a Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kasr El Aini Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kasr El Aini Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Gastric insufflation occurs when the inspiratory pressure exceeds the lower esophageal&#xD;
        sphincter pressure. Thus, it is desirable to avoid excessive positive pressure during mask&#xD;
        ventilation after induction of anesthesia and keeping the inspiratory pressure &lt;15-20&#xD;
        cmH2O.In patients with obesity the lower compliance of the respiratory system usually&#xD;
        requires higher inspiratory pressures to maintain adequate ventilation making these patients&#xD;
        more prone to gastric insufflation. This high risk of gastric insufflation can be aggravated&#xD;
        by the use of positive end-expiratory pressure (PEEP) which is recommended to avoid lung&#xD;
        atelectasis. The application of PEEP during mask ventilation increases the risk of gastric&#xD;
        insufflation as it reduces the pressure threshold at which gastric insufflation occur The&#xD;
        optimum ventilatory strategy during mask ventilation should achieve the balance between&#xD;
        adequate lung ventilation and avoiding gastric insufflation. In obese patients, it is not&#xD;
        clear whether the use of PEEP during mask ventilation would increase the risk of gastric&#xD;
        insufflation or not.&#xD;
  &#xD;
        We hypothesize that using zero end-expiratory pressure (ZEEP) or low PEEP during mask&#xD;
        ventilation would reduce the risk of gastric insufflation in comparison to high PEEP.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and&#xD;
        non-invasive blood pressure monitor) will be applied, intravenous line will be secured.&#xD;
        End-tidal CO2 monitoring will be initiated after induction of general anesthesia and starting&#xD;
        face-mask ventilation. All patients will be positioned in the ramped position (achieved by&#xD;
        elevation of the head and shoulders till achieving alignment of sternal notch and external&#xD;
        auditory meatus). Preoxygenation will be achieved by pressure support ventilation with 5&#xD;
        cmH2O and FiO2 of 0.8 without PEEP for three minutes. Induction of anesthesia will be&#xD;
        achieved using fentanyl (2 mcg/Kg lean body weight), propofol (2 mg/Kg lean body weight), and&#xD;
        rocuronium (0.6 mg/Kg ideal body weight). After loss of verbal response, mask ventilation&#xD;
        will be achieved by appropriate size face mask and oropharyngeal airway with 100% oxygen and&#xD;
        double hand jaw thrust head tilt maneuver. The included patients will be receiving&#xD;
        volume-controlled ventilation adjusted to deliver tidal volume of 8-10 mL/kg (ideal body&#xD;
        weight), at I:E ratio of 1:2, inspiratory pause of 0.5 s, respiratory rate of 12 breath per&#xD;
        minute, FiO2 of 0.8.&#xD;
  &#xD;
        The 3 study groups will receive the planned ventilatory strategy for 120 seconds.&#xD;
  &#xD;
        Assessment gastric insufflation during mask ventilation will be achieved by ultrasound&#xD;
        assessment of gastric antrum (at the sagittal plane between left lobe of the liver and&#xD;
        pancreas at level of the aorta). Gastric antral cross-sectional area (CSA) [ (longitudinal&#xD;
        diameter) X (anteroposterior diameter) X π /4] will be assessed in between contractions&#xD;
        before face mask ventilation and after insertion of endotracheal tube. [9] The proportion of&#xD;
        change in the CSA will be calculated as (delta CSA %= [CSA after intubation - baseline CSA] /&#xD;
        baseline CSA X 100). Significant gastric insufflation will be identified if the CSA increased&#xD;
        by &gt; 30% after endotracheal intubation in relation to the baseline.&#xD;
  &#xD;
        Intermittent gastric auscultation will be performed during mask ventilation at 30, 60, 90,&#xD;
        120 seconds by a blinded investigator (the presence of gastric insufflation will be defined&#xD;
        as a gurgling sound).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in gastric cross sectional area more than 30%</measure>
      <time_frame>1 minute before preoxygenation and 1 minute after intubation</time_frame>
      <description>number of patients with increase in percentage of change in gastric cross sectional area by more than 30%</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>gastric cross sectional area</measure>
      <time_frame>1 minute before preoxygenation and 1 minute after intubation</time_frame>
      <description>gastric cross sectional area measured by ultrasonography in cm2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>percentage of change in gastric cross sectional area</measure>
      <time_frame>1 minute before preoxygenation and 1 minute after intubation</time_frame>
      <description>gastric cross sectional area after intubation divided by gastric cross sectional area before preoxygenation %</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>tidal volume</measure>
      <time_frame>30 seconds until 120 seconds after induction of anesthesia</time_frame>
      <description>mL/kg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>end-tidal CO2</measure>
      <time_frame>30 seconds until 120 seconds after induction of anesthesia</time_frame>
      <description>mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak airway pressure</measure>
      <time_frame>30 seconds until 120 seconds after induction of anesthesia</time_frame>
      <description>mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gastric insufflation</measure>
      <time_frame>30 seconds until 120 seconds after induction of anesthesia</time_frame>
      <description>incidence of gastric insufflation by auscultation</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">126</enrollment>
    <condition>Gastric Insufflation</condition>
    <condition>Face Mask Ventilation</condition>
    <condition>Obese</condition>
    <condition>Positive End Expiratory Pressure</condition>
    <arm_group>
      <arm_group_label>ZEEP group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Low PEEP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>High PEEP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>zero PEEP</intervention_name>
      <description>zero end-expiratory pressure during face mask ventilation</description>
      <arm_group_label>ZEEP group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>low PEEP</intervention_name>
      <description>4 cmH2O PEEP during mask ventilation</description>
      <arm_group_label>Low PEEP</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>high PEEP</intervention_name>
      <description>8 cmH2O PEEP during mask ventilation</description>
      <arm_group_label>High PEEP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adult patients,&#xD;
  &#xD;
            -  with American Society of Anesthesiologists physical status II,&#xD;
  &#xD;
            -  body mass index &gt;35 kg/m2,&#xD;
  &#xD;
            -  scheduled for elective surgery under general anesthesia.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients at increased risk of difficult mask ventilation: Mallampati classification&#xD;
               &gt;2, presence of beard, limited neck extension, limited jaw protrusion, patients with&#xD;
               history of obstructive sleep apnea or STOP-Bang score&gt;2&#xD;
  &#xD;
            -  Patients at risk of aspiration or history of esophageal reflux.&#xD;
  &#xD;
            -  Patients with craniofacial anomalies, and pregnant patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>ahmed hasanin</last_name>
      <phone>01095076954</phone>
      <email>ahmedmohamedhasanin@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kasr Alaini Hospital</name>
        <address>
          <city>Cairo</city>
          <zip>11562</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
      <investigator_full_name>Maha Mostafa Ahmad, MD</investigator_full_name>
      <investigator_title>assistant professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>data from this study will be available from PI upon reasonable request</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979129
  org study id: MD-65-2022
  nct id: NCT05979129
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Gastric insufflation occurs when the inspiratory pressure exceeds the lower esophageal
        sphincter pressure. Thus, it is desirable to avoid excessive positive pressure during mask
        ventilation after induction of anesthesia and keeping the inspiratory pressure <15-20
        cmH2O.In patients with obesity the lower compliance of the respiratory system usually
        requires higher inspiratory pressures to maintain adequate ventilation making these patients
        more prone to gastric insufflation. This high risk of gastric insufflation can be aggravated
        by the use of positive end-expiratory pressure (PEEP) which is recommended to avoid lung
        atelectasis. The application of PEEP during mask ventilation increases the risk of gastric
        insufflation as it reduces the pressure threshold at which gastric insufflation occur The
        optimum ventilatory strategy during mask ventilation should achieve the balance between
        adequate lung ventilation and avoiding gastric insufflation. In obese patients, it is not
        clear whether the use of PEEP during mask ventilation would increase the risk of gastric
        insufflation or not.
  
        We hypothesize that using zero end-expiratory pressure (ZEEP) or low PEEP during mask
        ventilation would reduce the risk of gastric insufflation in comparison to high PEEP.
  Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and
        non-invasive blood pressure monitor) will be applied, intravenous line will be secured.
        End-tidal CO2 monitoring will be initiated after induction of general anesthesia and starting
        face-mask ventilation. All patients will be positioned in the ramped position (achieved by
        elevation of the head and shoulders till achieving alignment of sternal notch and external
        auditory meatus). Preoxygenation will be achieved by pressure support ventilation with 5
        cmH2O and FiO2 of 0.8 without PEEP for three minutes. Induction of anesthesia will be
        achieved using fentanyl (2 mcg/Kg lean body weight), propofol (2 mg/Kg lean body weight), and
        rocuronium (0.6 mg/Kg ideal body weight). After loss of verbal response, mask ventilation
        will be achieved by appropriate size face mask and oropharyngeal airway with 100% oxygen and
        double hand jaw thrust head tilt maneuver. The included patients will be receiving
        volume-controlled ventilation adjusted to deliver tidal volume of 8-10 mL/kg (ideal body
        weight), at I:E ratio of 1:2, inspiratory pause of 0.5 s, respiratory rate of 12 breath per
        minute, FiO2 of 0.8.
  
        The 3 study groups will receive the planned ventilatory strategy for 120 seconds.
  
        Assessment gastric insufflation during mask ventilation will be achieved by ultrasound
        assessment of gastric antrum (at the sagittal plane between left lobe of the liver and
        pancreas at level of the aorta). Gastric antral cross-sectional area (CSA) [ (longitudinal
        diameter) X (anteroposterior diameter) X π /4] will be assessed in between contractions
        before face mask ventilation and after insertion of endotracheal tube. [9] The proportion of
        change in the CSA will be calculated as (delta CSA %= [CSA after intubation - baseline CSA] /
        baseline CSA X 100). Significant gastric insufflation will be identified if the CSA increased
        by > 30% after endotracheal intubation in relation to the baseline.
  
        Intermittent gastric auscultation will be performed during mask ventilation at 30, 60, 90,
        120 seconds by a blinded investigator (the presence of gastric insufflation will be defined
        as a gurgling sound).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Change in gastric cross sectional area more than 30%
  time frame: 1 minute before preoxygenation and 1 minute after intubation
  description: number of patients with increase in percentage of change in gastric cross sectional area by more than 30%
  measure: gastric cross sectional area
  time frame: 1 minute before preoxygenation and 1 minute after intubation
  description: gastric cross sectional area measured by ultrasonography in cm2
  measure: percentage of change in gastric cross sectional area
  time frame: 1 minute before preoxygenation and 1 minute after intubation
  description: gastric cross sectional area after intubation divided by gastric cross sectional area before preoxygenation %
  measure: tidal volume
  time frame: 30 seconds until 120 seconds after induction of anesthesia
  description: mL/kg
  measure: end-tidal CO2
  time frame: 30 seconds until 120 seconds after induction of anesthesia
  description: mmHg
  measure: Peak airway pressure
  time frame: 30 seconds until 120 seconds after induction of anesthesia
  description: mmHg
  measure: Gastric insufflation
  time frame: 30 seconds until 120 seconds after induction of anesthesia
  description: incidence of gastric insufflation by auscultation
  arm group label: ZEEP group
  arm group type: Active Comparator
  arm group label: Low PEEP
  arm group type: Active Comparator
  arm group label: High PEEP
  arm group type: Active Comparator
  intervention type: Other
  intervention name: zero PEEP
  description: zero end-expiratory pressure during face mask ventilation
  arm group label: ZEEP group
  intervention type: Other
  intervention name: low PEEP
  description: 4 cmH2O PEEP during mask ventilation
  arm group label: Low PEEP
  intervention type: Other
  intervention name: high PEEP
  description: 8 cmH2O PEEP during mask ventilation
  arm group label: High PEEP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: ahmed hasanin
  phone: 01095076954
  email: ahmedmohamedhasanin@gmail.com
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Kasr El Aini Hospital
  investigator full name: Maha Mostafa Ahmad, MD
  investigator title: assistant professor
  mesh term: Obesity
  sharing ipd: No
  ipd description: data from this study will be available from PI upon reasonable request