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/NCT06000969</url>
    </required_header>
    <id_info>
      <org_study_id>36264MD12</org_study_id>
      <nct_id>NCT06000969</nct_id>
    </id_info>
    <brief_title>Lung Recruitment Manoeuvre in Morbidly Obese Patients Underdoing Laparoscopic Bariatric Surgery</brief_title>
    <official_title>Conventional Versus Ultrasound-guided Lung Recruitment Manoeuvre in Morbidly Obese Patients Underdoing Laparoscopic Bariatric Surgery: Prospective Randomized Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tanta University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</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>
        Lung ultrasonography is an easy-to-use, portable, non-invasive, visual, and non-radiative&#xD;
        technique that has been widely used in clinical monitoring and diagnosis.&#xD;
  &#xD;
        Many studies have demonstrated that pulmonary ultrasonography can evaluate the degree of&#xD;
        aeration loss and diagnose atelectasis accurately by using a validated semiquantitative score&#xD;
        in the perioperative period, and lung ultrasonic imaging can be conducive to confirming the&#xD;
        effects of lung recruitment manoeuvres.&#xD;
  &#xD;
        This clinical trial suggested that the use of ultrasound-guided recruitment maneuver in&#xD;
        morbidly obese patients scheduled for laparoscopic bariatric surgery can improve the lung&#xD;
        aeration, decrease the incidence of basal lung atelectasis, decrease the incidence of&#xD;
        intraoperative&amp; postoperative oxygen desaturation, and reduce the incidence of post operative&#xD;
        pulmonary complications.&#xD;
  &#xD;
        The aim of this prospective randomized clinical study is to compare the conventional&#xD;
        recruitment manoeuvre and ultrasound-guided recruitment manoeuvre in morbidly obese patients&#xD;
        scheduled for laparoscopic bariatric surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        -  This prospective randomized clinical double-blinded study will be carried out at&#xD;
             Anesthesiology Department in Tanta University Hospitals for one year from August 2023 to&#xD;
             August 2024 after approval from our institutional ethical committee. All enrolled&#xD;
             patients will sign an informed written consent to participate in the study.&#xD;
  &#xD;
          -  Every patient will receive an explanation of the purpose of the study and have secret&#xD;
             code number to ensure privacy and confidentiality, all given data will be used for&#xD;
             scientific purposes only.&#xD;
  &#xD;
          -  Any unexpected risks encountered during the research will be cleared to the&#xD;
             participants, as well as to the Ethical Committee on time. The risk at the study&#xD;
             includes increased risk of bradycardia and hypotension that will be managed by adequate&#xD;
             monitoring, atropine, IV fluids, and ephedrine.&#xD;
  &#xD;
        -Patients will be randomly allocated in one of the two equal groups using a&#xD;
        computer-generated table of random numbers to :-&#xD;
  &#xD;
        • Conventional group (group C); 30 patients: Patients will be shifted to 100% Oxygen then;&#xD;
        the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O&#xD;
        for 30 seconds.&#xD;
  &#xD;
        • Ultrasound-guided group (group US); 30 patients: Patients will be shifted to 100% Oxygen&#xD;
        then; the recruitment maneuver will be performed under the direct real-time guidance of&#xD;
        ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This&#xD;
        will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10&#xD;
        cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum&#xD;
        airway pressure will be limited to 40 cmH2O. This could be repeated if needed.&#xD;
  &#xD;
        -Anesthesia technique&#xD;
  &#xD;
        I-Preoperative assessment:&#xD;
  &#xD;
        ▪ All patients will be assessed preoperatively at the Anesthesia Clinic through history,&#xD;
        physical examination and requesting the appropriate investigations.&#xD;
  &#xD;
        II-In the Holding Area:&#xD;
  &#xD;
          -  Patient counselling regarding anesthesia technique and surgery.&#xD;
  &#xD;
          -  Secured IV line.&#xD;
  &#xD;
        III- In the Operation Room:&#xD;
  &#xD;
          -  Standard Monitoring: On arrival of the patient to the operating theater and before&#xD;
             induction of anesthesia, all standard monitors will be applied, including heart rate&#xD;
             (HR), ECG, oxygen saturation (SpO2), end-tidal CO2, non-invasive blood pressure, and&#xD;
             temperature.&#xD;
  &#xD;
          -  Induction of anesthesia: all patients will be pre-oxygenated with 80% oxygen for 3&#xD;
             minutes before induction. Anesthesia will be induced by slowly titrating doses of&#xD;
             intravenous fentanyl (2 ug/kg of lean body weight) and propofol (1 mg/kg of lean body&#xD;
             weight). Intubation will be facilitated with atracurium (0.5 mg/kg of lean body weight).&#xD;
             Anesthesia will be maintained with atracurium, isoflurane of 1 MAC and fraction inspired&#xD;
             Oxygen of 0.5 for each patient.&#xD;
  &#xD;
          -  Mechanical ventilation protocol: patients will receive the standard ventilation protocol&#xD;
             as follows: volume-controlled ventilation mode, with a tidal volume of 4-6 mL/kg of&#xD;
             predicted body weight, inspiratory: expiratory ratio 1: 2, PEEP 5 cmH2O, initial&#xD;
             respiratory rate is 12/m then adjusted to keep end-tidal carbon dioxide tension (EtCO2)&#xD;
             between 35- and 40-mm Hg, and inspired oxygen fraction of 0.5 with total gas flow 1L/m.&#xD;
             The patients and investigators who will be responsible for assessing the primary&#xD;
             outcomes will be blinded to study group assignment. However, the attending&#xD;
             anesthesiologists, intraoperative nursing staff, and intraoperative assessors will not&#xD;
             be blinded to study group assignment.&#xD;
  &#xD;
          -  Positioning and pneumoperitoneum: the patients will be put in reverse trendelenburg&#xD;
             position, 30°C head-up position slowly, the position will be kept until the end of&#xD;
             surgery.&#xD;
  &#xD;
        Intraabdominal pressure will be maintained between 12 ± 3 cmH2O during surgery.&#xD;
  &#xD;
        ▪ Lung ultrasound examination: will be done: After the induction of anaesthesia (time point&#xD;
        T1). After pneumoperitoneum (time point T2). At the end of surgery (before administrating&#xD;
        reversal agents for neuromuscular blockade; (time point T3).&#xD;
  &#xD;
          -  Lung recruitment: recruitment maneuver will be performed in each group as described&#xD;
             before after every intraoperative lung ultrasound examination. Intra-abdominal pressure&#xD;
             will be recorded. If hypotension (MAP&lt;65mmhg), bradycardia (heart rate&lt;50/m.) or oxygen&#xD;
             desaturation (spO2&lt;95%) has been occurred, rescue strategy will be applied as described&#xD;
             later.&#xD;
  &#xD;
          -  Rescue strategy for oxygen desaturation: In both groups, when SpO2 decreased to 95% or&#xD;
             lower, the following rescue ventilation strategies will be performed in a stepwise&#xD;
             manner (i.e., if SpO2 did not increase after a step, then the following step was&#xD;
             applied; otherwise, no further steps were applied).&#xD;
  &#xD;
        Steps were performed according to the following order:&#xD;
  &#xD;
          -  Step (1), three rounds of recruitment maneuvers with a pressure of 30 cmH2O for 10 s.&#xD;
  &#xD;
          -  Step (2), three rounds of recruitment maneuvers with a pressure of 35 cmH2O for 10 s.&#xD;
  &#xD;
          -  Step (3), increase FIO2 to 1.0. If SpO2 did not increase after all three rescue&#xD;
             strategies, the ventilation strategies could be modified according to the attending&#xD;
             anesthesiologist's judgement.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">August 13, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 13, 2024</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>
      <intervention_model_description>Patients will be randomly allocated in one of the two equal groups using a computer-generated table of random numbers to :-&#xD;
  Conventional group (group C); 30 patients:&#xD;
  Ultrasound-guided group (group US); 30 patients:</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The participants will be kept blind through the use of ultrasound assessment in both groups.&#xD;
  Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>the change of Lung Ultrasound Score</measure>
      <time_frame>2 hours</time_frame>
      <description>Assessment of the changes in the lung ultrasound score</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The incidence of atelectasis</measure>
      <time_frame>2 hours</time_frame>
      <description>defined as LUS of ≥ 2 for any of the 12 regions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of intra-operative desaturation</measure>
      <time_frame>3 hours</time_frame>
      <description>defined as an SpO2 &lt;95%</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Bariatric Surgery</condition>
    <condition>Obesity, Morbid</condition>
    <arm_group>
      <arm_group_label>Conventional group (group C)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ultrasound-guided group (group US)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Lung Recruitment Conventional</intervention_name>
      <description>the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.</description>
      <arm_group_label>Conventional group (group C)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Lung Recruitment Ultrasound</intervention_name>
      <description>the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.</description>
      <arm_group_label>Ultrasound-guided group (group US)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adult morbidly obese patients of BMI more than 40, scheduled for laparoscopic&#xD;
               bariatric surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient refusal&#xD;
  &#xD;
            -  Patients with history of severe obstructive or restrictive pulmonary disease.&#xD;
  &#xD;
            -  Patients with severe obstructive sleep apnea (OSA).&#xD;
  &#xD;
            -  Presence of emphysematous lung bullae.&#xD;
  &#xD;
            -  Decompensated cardiac disease (NYHA class 3 or 4).&#xD;
  &#xD;
            -  Patients with uncontrolled hepatic or renal disorders.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sameh Ismaiel, M.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistant Professor of Anesthesia and Intensive Care, Tanta University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sohair Soliman, Professor</last_name>
      <phone>00201283929049</phone>
      <email>sohairsoliman@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mohammed Aly, Professor</last_name>
      <phone>00201099957971</phone>
      <email>moh_aly_2005@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Tanta University</name>
        <address>
          <city>Tanta</city>
          <state>Algharbia</state>
          <zip>31511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sameh Abdelkhalik, M.D</last_name>
        <phone>+201002977048</phone>
        <email>samehabdelkhalik1982@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Mohamed Aly, M.D</last_name>
        <phone>00201099957971</phone>
        <email>moh_aly_2005@hotmail.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Tanta University hospitals</name>
        <address>
          <city>Tanta</city>
          <zip>31511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sohair Soliman, Professor</last_name>
        <phone>00201283929049</phone>
        <email>sohairsoliman@hotmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Mohamed Abduallah, M.D</last_name>
        <phone>00201099957971</phone>
        <email>moh_aly_2005@hotmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Sameh Abdelkhalik Ahmed Ismaiel</investigator_full_name>
      <investigator_title>Assistant Professor of Anesthesia and Intensive Care</investigator_title>
    </responsible_party>
    <keyword>Morbidly obese, Bariatric surgery, Lung recruitment</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>The IPD will be available with the principle investigator within 6 months after publishing the study.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>within 6 months after publishing the study.</ipd_time_frame>
      <ipd_access_criteria>Contact samehabdelkhalik1982@gmail.com</ipd_access_criteria>
    </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/NCT06000969
  org study id: 36264MD12
  nct id: NCT06000969
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Lung ultrasonography is an easy-to-use, portable, non-invasive, visual, and non-radiative
        technique that has been widely used in clinical monitoring and diagnosis.
  
        Many studies have demonstrated that pulmonary ultrasonography can evaluate the degree of
        aeration loss and diagnose atelectasis accurately by using a validated semiquantitative score
        in the perioperative period, and lung ultrasonic imaging can be conducive to confirming the
        effects of lung recruitment manoeuvres.
  
        This clinical trial suggested that the use of ultrasound-guided recruitment maneuver in
        morbidly obese patients scheduled for laparoscopic bariatric surgery can improve the lung
        aeration, decrease the incidence of basal lung atelectasis, decrease the incidence of
        intraoperative& postoperative oxygen desaturation, and reduce the incidence of post operative
        pulmonary complications.
  
        The aim of this prospective randomized clinical study is to compare the conventional
        recruitment manoeuvre and ultrasound-guided recruitment manoeuvre in morbidly obese patients
        scheduled for laparoscopic bariatric surgery.
  -  This prospective randomized clinical double-blinded study will be carried out at
             Anesthesiology Department in Tanta University Hospitals for one year from August 2023 to
             August 2024 after approval from our institutional ethical committee. All enrolled
             patients will sign an informed written consent to participate in the study.
  
          -  Every patient will receive an explanation of the purpose of the study and have secret
             code number to ensure privacy and confidentiality, all given data will be used for
             scientific purposes only.
  
          -  Any unexpected risks encountered during the research will be cleared to the
             participants, as well as to the Ethical Committee on time. The risk at the study
             includes increased risk of bradycardia and hypotension that will be managed by adequate
             monitoring, atropine, IV fluids, and ephedrine.
  
        -Patients will be randomly allocated in one of the two equal groups using a
        computer-generated table of random numbers to :-
  
        • Conventional group (group C); 30 patients: Patients will be shifted to 100% Oxygen then;
        the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O
        for 30 seconds.
  
        • Ultrasound-guided group (group US); 30 patients: Patients will be shifted to 100% Oxygen
        then; the recruitment maneuver will be performed under the direct real-time guidance of
        ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This
        will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10
        cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum
        airway pressure will be limited to 40 cmH2O. This could be repeated if needed.
  
        -Anesthesia technique
  
        I-Preoperative assessment:
  
        ▪ All patients will be assessed preoperatively at the Anesthesia Clinic through history,
        physical examination and requesting the appropriate investigations.
  
        II-In the Holding Area:
  
          -  Patient counselling regarding anesthesia technique and surgery.
  
          -  Secured IV line.
  
        III- In the Operation Room:
  
          -  Standard Monitoring: On arrival of the patient to the operating theater and before
             induction of anesthesia, all standard monitors will be applied, including heart rate
             (HR), ECG, oxygen saturation (SpO2), end-tidal CO2, non-invasive blood pressure, and
             temperature.
  
          -  Induction of anesthesia: all patients will be pre-oxygenated with 80% oxygen for 3
             minutes before induction. Anesthesia will be induced by slowly titrating doses of
             intravenous fentanyl (2 ug/kg of lean body weight) and propofol (1 mg/kg of lean body
             weight). Intubation will be facilitated with atracurium (0.5 mg/kg of lean body weight).
             Anesthesia will be maintained with atracurium, isoflurane of 1 MAC and fraction inspired
             Oxygen of 0.5 for each patient.
  
          -  Mechanical ventilation protocol: patients will receive the standard ventilation protocol
             as follows: volume-controlled ventilation mode, with a tidal volume of 4-6 mL/kg of
             predicted body weight, inspiratory: expiratory ratio 1: 2, PEEP 5 cmH2O, initial
             respiratory rate is 12/m then adjusted to keep end-tidal carbon dioxide tension (EtCO2)
             between 35- and 40-mm Hg, and inspired oxygen fraction of 0.5 with total gas flow 1L/m.
             The patients and investigators who will be responsible for assessing the primary
             outcomes will be blinded to study group assignment. However, the attending
             anesthesiologists, intraoperative nursing staff, and intraoperative assessors will not
             be blinded to study group assignment.
  
          -  Positioning and pneumoperitoneum: the patients will be put in reverse trendelenburg
             position, 30°C head-up position slowly, the position will be kept until the end of
             surgery.
  
        Intraabdominal pressure will be maintained between 12 ± 3 cmH2O during surgery.
  
        ▪ Lung ultrasound examination: will be done: After the induction of anaesthesia (time point
        T1). After pneumoperitoneum (time point T2). At the end of surgery (before administrating
        reversal agents for neuromuscular blockade; (time point T3).
  
          -  Lung recruitment: recruitment maneuver will be performed in each group as described
             before after every intraoperative lung ultrasound examination. Intra-abdominal pressure
             will be recorded. If hypotension (MAP<65mmhg), bradycardia (heart rate<50/m.) or oxygen
             desaturation (spO2<95%) has been occurred, rescue strategy will be applied as described
             later.
  
          -  Rescue strategy for oxygen desaturation: In both groups, when SpO2 decreased to 95% or
             lower, the following rescue ventilation strategies will be performed in a stepwise
             manner (i.e., if SpO2 did not increase after a step, then the following step was
             applied; otherwise, no further steps were applied).
  
        Steps were performed according to the following order:
  
          -  Step (1), three rounds of recruitment maneuvers with a pressure of 30 cmH2O for 10 s.
  
          -  Step (2), three rounds of recruitment maneuvers with a pressure of 35 cmH2O for 10 s.
  
          -  Step (3), increase FIO2 to 1.0. If SpO2 did not increase after all three rescue
             strategies, the ventilation strategies could be modified according to the attending
             anesthesiologist's judgement.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients will be randomly allocated in one of the two equal groups using a computer-generated table of random numbers to :-
  Conventional group (group C); 30 patients:
  Ultrasound-guided group (group US); 30 patients:
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  masking description: The participants will be kept blind through the use of ultrasound assessment in both groups.
  Outcome assessors will be blinded as they will be anesthesia resident and nurse not participating in the study.
  measure: the change of Lung Ultrasound Score
  time frame: 2 hours
  description: Assessment of the changes in the lung ultrasound score
  measure: The incidence of atelectasis
  time frame: 2 hours
  description: defined as LUS of ≥ 2 for any of the 12 regions
  measure: The incidence of intra-operative desaturation
  time frame: 3 hours
  description: defined as an SpO2 <95%
  arm group label: Conventional group (group C)
  arm group type: Experimental
  description: Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.
  arm group label: Ultrasound-guided group (group US)
  arm group type: Experimental
  description: Patients will be shifted to 100% Oxygen then; the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.
  intervention type: Device
  intervention name: Lung Recruitment Conventional
  description: the recruitment maneuver will be performed by manual inflation with a pressure of 30 cmH2O for 30 seconds.
  arm group label: Conventional group (group C)
  intervention type: Device
  intervention name: Lung Recruitment Ultrasound
  description: the recruitment maneuver will be performed under the direct real-time guidance of ultrasound if atelectasis (defined as LUS of ≥ 2 for any of the 12 regions) is present. This will be done by manual inflation with a pressure of 10 cmH2O for 10 seconds, increased 10 cmH2O every 10 seconds until no collapsed areas are visible on the ultrasound, the maximum airway pressure will be limited to 40 cmH2O. This could be repeated if needed.
  arm group label: Ultrasound-guided group (group US)
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Sameh Ismaiel, M.D
  role: Principal Investigator
  affiliation: Assistant Professor of Anesthesia and Intensive Care, Tanta University
  last name: Sohair Soliman, Professor
  phone: 00201283929049
  email: sohairsoliman@hotmail.com
  last name: Mohammed Aly, Professor
  phone: 00201099957971
  email: moh_aly_2005@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Tanta University
  investigator full name: Sameh Abdelkhalik Ahmed Ismaiel
  investigator title: Assistant Professor of Anesthesia and Intensive Care
  mesh term: Obesity, Morbid
  sharing ipd: Yes
  ipd description: The IPD will be available with the principle investigator within 6 months after publishing the study.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: within 6 months after publishing the study.
  ipd access criteria: Contact samehabdelkhalik1982@gmail.com