<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/NCT02966535</url>
  </required_header>
  <id_info>
    <org_study_id>1609-102-793</org_study_id>
    <nct_id>NCT02966535</nct_id>
  </id_info>
  <brief_title>The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial</brief_title>
  <official_title>The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gas exchange disturbance frequently occurs in steep Trendelenburg position during&#xD;
      robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic&#xD;
      pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity, hypercapnia&#xD;
      as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during&#xD;
      mechanical ventilation has been reported to be improve gas exchange in adult respiratory&#xD;
      distress syndrome. The investigators attempt to test the hypothesis that prolonged&#xD;
      inspiratory time may improve the gas exchange during robot-assisted laparoscopic urologic&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gas exchange disturbance frequently occurs in steep Trendelenburg position during&#xD;
      robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic&#xD;
      pressure and absorbed CO2 gas insufflated into abdominal cavity, hypercapnia as well as&#xD;
      hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical&#xD;
      ventilation has been reported to be improve gas exchange in adult respiratory distress&#xD;
      syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time&#xD;
      (I:E ratio = 1:1) may improve the gas exchange during robot-assisted laparoscopic urologic&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PaCO2 (mmHg) in the patient's arterial blood gas analysis</measure>
    <time_frame>60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning</time_frame>
    <description>PaCO2 (arterial partial pressure of carbon dioxide)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PaCO2 (mmHg) in the patient's arterial blood gas analysis</measure>
    <time_frame>5 minutes after anesthesia induction</time_frame>
    <description>PaCO2 (arterial partial pressure of carbon dioxide)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaO2 (mmHg) in the patient's arterial blood gas analysis</measure>
    <time_frame>5 minutes after anesthesia induction</time_frame>
    <description>PaO2 (arterial partial pressure of oxygen)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaO2 (mmHg) in the patient's arterial blood gas analysis</measure>
    <time_frame>60 minutes after anesthesia induction</time_frame>
    <description>PaO2 (arterial partial pressure of oxygen)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaCO2 (mmHg) in the patient's arterial blood gas analysis</measure>
    <time_frame>120 minutes after anesthesia induction</time_frame>
    <description>PaCO2 (arterial partial pressure of carbon dioxide)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaO2 (mmHg) in the patient's arterial blood gas analysis</measure>
    <time_frame>120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning</time_frame>
    <description>PaO2 (arterial partial pressure of oxygen)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaCO2 (mmHg) in the patient's arterial blood gas analysis</measure>
    <time_frame>10 min after restoration of supine position</time_frame>
    <description>PaCO2 (arterial partial pressure of carbon dioxide)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaO2 (mmHg) in the patient's arterial blood gas analysis</measure>
    <time_frame>10 min after restoration of supine position</time_frame>
    <description>PaO2 (arterial partial pressure of oxygen)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory compliance (Static, Dynamic)</measure>
    <time_frame>5 minutes after anesthesia induction</time_frame>
    <description>Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory compliance (Static, Dynamic)</measure>
    <time_frame>60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning</time_frame>
    <description>Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory compliance (Static, Dynamic)</measure>
    <time_frame>120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning</time_frame>
    <description>Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen index</measure>
    <time_frame>5 minutes after anesthesia induction</time_frame>
    <description>oxygen index calculated by PaO2/inspired oxygen fraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen index</measure>
    <time_frame>60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning</time_frame>
    <description>oxygen index calculated by PaO2/inspired oxygen fraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen index</measure>
    <time_frame>120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning</time_frame>
    <description>oxygen index calculated by PaO2/inspired oxygen fraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alveolar-arterial oxygen difference</measure>
    <time_frame>5 minutes after anesthesia induction</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alveolar-arterial oxygen difference</measure>
    <time_frame>60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alveolar-arterial oxygen difference</measure>
    <time_frame>120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Prostatic Neoplasm</condition>
  <condition>Urinary Bladder Neoplasm</condition>
  <arm_group>
    <arm_group_label>1:2, 1:1 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inspiratory to expiratory time ratio (I:E ratio) of 1:2 during the first one hour of laparoscopy and then switched to I:E ratio of 1:1 during the rest time of laparoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1:1, 1:2 group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inspiratory to expiratory time ratio (I:E ratio) of 1:1 during the first one hour of laparoscopy and then switched to I:E ratio of 1:2 during the rest time of laparoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)</intervention_name>
    <description>Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)</description>
    <arm_group_label>1:2, 1:1 group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)</intervention_name>
    <description>Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)</description>
    <arm_group_label>1:1, 1:2 group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status class I-II and scheduled for an&#xD;
             elective robot-assisted laparoscopic radical prostatectomy or robot-assisted&#xD;
             laparoscopic radical cystectomy&#xD;
&#xD;
          -  Patients who voluntarily decides to participate in the trial and has agreed in written&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with the anatomical abnormalities of respiratory system(abnormal airway&#xD;
             anatomy, severe scoliosis, post-pneumonectomy state), severe chronic respiratory&#xD;
             diseases, chronic obstructive pulmonary disease (COPD), asthma, heart failure, obesity&#xD;
             ( Body Mass Index [BMI] &gt; 30kg/m2), severe hepatic failure or renal failure&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>De Carlo F, Celestino F, Verri C, Masedu F, Liberati E, Di Stasi SM. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: surgical, oncological, and functional outcomes: a systematic review. Urol Int. 2014;93(4):373-83. doi: 10.1159/000366008. Epub 2014 Sep 23.</citation>
    <PMID>25277444</PMID>
  </reference>
  <reference>
    <citation>Gainsburg DM. Anesthetic concerns for robotic-assisted laparoscopic radical prostatectomy. Minerva Anestesiol. 2012 May;78(5):596-604. Epub 2012 Mar 13.</citation>
    <PMID>22415437</PMID>
  </reference>
  <reference>
    <citation>Kim MS, Kim NY, Lee KY, Choi YD, Hong JH, Bai SJ. The impact of two different inspiratory to expiratory ratios (1:1 and 1:2) on respiratory mechanics and oxygenation during volume-controlled ventilation in robot-assisted laparoscopic radical prostatectomy: a randomized controlled trial. Can J Anaesth. 2015 Sep;62(9):979-87. doi: 10.1007/s12630-015-0383-2. Epub 2015 Apr 14.</citation>
    <PMID>25869025</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 13, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>March 12, 2019</last_update_submitted>
  <last_update_submitted_qc>March 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Won Ho Kim, MD</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02966535
org study id: 1609-102-793
nct id: NCT02966535
lead sponsor: 
has dmc: No
Gas exchange disturbance frequently occurs in steep Trendelenburg position during
      robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic
      pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity, hypercapnia
      as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during
      mechanical ventilation has been reported to be improve gas exchange in adult respiratory
      distress syndrome. The investigators attempt to test the hypothesis that prolonged
      inspiratory time may improve the gas exchange during robot-assisted laparoscopic urologic
      surgery.
Gas exchange disturbance frequently occurs in steep Trendelenburg position during
      robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic
      pressure and absorbed CO2 gas insufflated into abdominal cavity, hypercapnia as well as
      hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical
      ventilation has been reported to be improve gas exchange in adult respiratory distress
      syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time
      (I:E ratio = 1:1) may improve the gas exchange during robot-assisted laparoscopic urologic
      surgery.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: PaCO2 (mmHg) in the patient's arterial blood gas analysis
time frame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
description: PaCO2 (arterial partial pressure of carbon dioxide)
measure: PaCO2 (mmHg) in the patient's arterial blood gas analysis
time frame: 5 minutes after anesthesia induction
description: PaCO2 (arterial partial pressure of carbon dioxide)
measure: PaO2 (mmHg) in the patient's arterial blood gas analysis
time frame: 5 minutes after anesthesia induction
description: PaO2 (arterial partial pressure of oxygen)
measure: PaO2 (mmHg) in the patient's arterial blood gas analysis
time frame: 60 minutes after anesthesia induction
description: PaO2 (arterial partial pressure of oxygen)
measure: PaCO2 (mmHg) in the patient's arterial blood gas analysis
time frame: 120 minutes after anesthesia induction
description: PaCO2 (arterial partial pressure of carbon dioxide)
measure: PaO2 (mmHg) in the patient's arterial blood gas analysis
time frame: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
description: PaO2 (arterial partial pressure of oxygen)
measure: PaCO2 (mmHg) in the patient's arterial blood gas analysis
time frame: 10 min after restoration of supine position
description: PaCO2 (arterial partial pressure of carbon dioxide)
measure: PaO2 (mmHg) in the patient's arterial blood gas analysis
time frame: 10 min after restoration of supine position
description: PaO2 (arterial partial pressure of oxygen)
measure: Respiratory compliance (Static, Dynamic)
time frame: 5 minutes after anesthesia induction
description: Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
measure: Respiratory compliance (Static, Dynamic)
time frame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
description: Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
measure: Respiratory compliance (Static, Dynamic)
time frame: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
description: Static compliance = exhaled tidal volume / (plateau pressure - PEEP), Dynamic compliance = Exhaled tidal volume / (PIP - PEEP)
measure: oxygen index
time frame: 5 minutes after anesthesia induction
description: oxygen index calculated by PaO2/inspired oxygen fraction
measure: oxygen index
time frame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
description: oxygen index calculated by PaO2/inspired oxygen fraction
measure: oxygen index
time frame: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
description: oxygen index calculated by PaO2/inspired oxygen fraction
measure: Alveolar-arterial oxygen difference
time frame: 5 minutes after anesthesia induction
measure: Alveolar-arterial oxygen difference
time frame: 60 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
measure: Alveolar-arterial oxygen difference
time frame: 120 min after the initiation of pneumoperitoneum with steep Trendelenburg positioning
arm group label: 1:2, 1:1 group
arm group type: Experimental
description: Inspiratory to expiratory time ratio (I:E ratio) of 1:2 during the first one hour of laparoscopy and then switched to I:E ratio of 1:1 during the rest time of laparoscopy.
arm group label: 1:1, 1:2 group
arm group type: Active Comparator
description: Inspiratory to expiratory time ratio (I:E ratio) of 1:1 during the first one hour of laparoscopy and then switched to I:E ratio of 1:2 during the rest time of laparoscopy.
intervention type: Device
intervention name: Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)
description: Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)
arm group label: 1:2, 1:1 group
intervention type: Device
intervention name: Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)
description: Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)
arm group label: 1:1, 1:2 group
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
citation: De Carlo F, Celestino F, Verri C, Masedu F, Liberati E, Di Stasi SM. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: surgical, oncological, and functional outcomes: a systematic review. Urol Int. 2014;93(4):373-83. doi: 10.1159/000366008. Epub 2014 Sep 23.
PMID: 25277444
citation: Gainsburg DM. Anesthetic concerns for robotic-assisted laparoscopic radical prostatectomy. Minerva Anestesiol. 2012 May;78(5):596-604. Epub 2012 Mar 13.
PMID: 22415437
citation: Kim MS, Kim NY, Lee KY, Choi YD, Hong JH, Bai SJ. The impact of two different inspiratory to expiratory ratios (1:1 and 1:2) on respiratory mechanics and oxygenation during volume-controlled ventilation in robot-assisted laparoscopic radical prostatectomy: a randomized controlled trial. Can J Anaesth. 2015 Sep;62(9):979-87. doi: 10.1007/s12630-015-0383-2. Epub 2015 Apr 14.
PMID: 25869025
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Won Ho Kim, MD
investigator title: Clinical Associate Professor
mesh term: Neoplasms
mesh term: Prostatic Neoplasms
mesh term: Urinary Bladder Neoplasms
sharing ipd: No