<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/NCT03031613</url>
  </required_header>
  <id_info>
    <org_study_id>3-2016-0263</org_study_id>
    <nct_id>NCT03031613</nct_id>
  </id_info>
  <brief_title>Effects of PEEP on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy</brief_title>
  <official_title>Effects of Positive End Expiratory Pressure (PEEP) on Intracranial and Intraocular Pressure in Robot-assisted Laparoscopic Radical Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gangnam Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gangnam Severance Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral&#xD;
      pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted&#xD;
      laparoscopic radical prostatectomy (RALRP)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Application of PEEPmay reduce pulmonary complication following RALRP. Meanwhile, it may&#xD;
      increase ICP and IOP, which has been debated for decades. Moreover, Trendelenburg position&#xD;
      and pneumoperitoneum, which are mandatory for RALRP, may augment elevation of ICP and IOP.&#xD;
      This study aims to investigate the effects of PEEP on the ICP and IOP in patients undergoing&#xD;
      RALRP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IOP</measure>
    <time_frame>Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min</time_frame>
    <description>IOP is directly assessed by measurement of IOP with the Tono-Pen AVIA®</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICP</measure>
    <time_frame>Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min</time_frame>
    <description>ICP is indirectly assessed by measurement of optic nerve sheath diameter(ONSD) with the ultrasound</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>PEEP group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of 5 cmH2O PEEP during mechanical ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ZEEP group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No application of PEEP during mechanical ventilation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PEEP group</intervention_name>
    <description>Application of 5cmH20 positive end expiratory pressure</description>
    <arm_group_label>PEEP group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ZEEP group</intervention_name>
    <description>No application of positive end expiratory pressure</description>
    <arm_group_label>ZEEP group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing robotic-assisted laparoscopic radical prostatectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of opthalmic disease or surgery&#xD;
&#xD;
          -  History of brain disease or surgery&#xD;
&#xD;
          -  Known ICP elevation&#xD;
&#xD;
          -  Known IOP elevation&#xD;
&#xD;
          -  Presence of lung bullae on chest x-ray&#xD;
&#xD;
          -  History of pneumothorax&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dong Woo Han</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gangnam Severance Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dong Woo Han</last_name>
    <phone>02-2019-3529</phone>
    <email>hanesth@yuhs.ac</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yonsei University Medical College Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dong Woo Han, MD., Ph.D.</last_name>
      <phone>82220193529</phone>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gangnam Severance Hospital</investigator_affiliation>
    <investigator_full_name>Dong Woo Han</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>intraocular pressure</keyword>
  <keyword>intracerebral pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic 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/NCT03031613
org study id: 3-2016-0263
nct id: NCT03031613
lead sponsor: 
has dmc: Yes
To investigate the effects of positive end-expiratory pressure (PEEP) on the intracerebral
      pressure (ICP) and intraocular pressure (IOP) in patients undergoing robot assisted
      laparoscopic radical prostatectomy (RALRP)
Application of PEEPmay reduce pulmonary complication following RALRP. Meanwhile, it may
      increase ICP and IOP, which has been debated for decades. Moreover, Trendelenburg position
      and pneumoperitoneum, which are mandatory for RALRP, may augment elevation of ICP and IOP.
      This study aims to investigate the effects of PEEP on the ICP and IOP in patients undergoing
      RALRP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: IOP
time frame: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min
description: IOP is directly assessed by measurement of IOP with the Tono-Pen AVIA®
measure: ICP
time frame: Changes from pre-induction (baseline) at Post-induction 5 min, Pneumoperitoneum insufflation and Trendelenburg position 5 min, Pneumoperitoneum insufflation and Trendelenburg position 30 min, Penumoperitoneum desufflation and supine position 5 min
description: ICP is indirectly assessed by measurement of optic nerve sheath diameter(ONSD) with the ultrasound
arm group label: PEEP group
arm group type: Experimental
description: Application of 5 cmH2O PEEP during mechanical ventilation
arm group label: ZEEP group
arm group type: Active Comparator
description: No application of PEEP during mechanical ventilation
intervention type: Procedure
intervention name: PEEP group
description: Application of 5cmH20 positive end expiratory pressure
arm group label: PEEP group
intervention type: Procedure
intervention name: ZEEP group
description: No application of positive end expiratory pressure
arm group label: ZEEP group
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Dong Woo Han
role: Principal Investigator
affiliation: Gangnam Severance Hospital
last name: Dong Woo Han
phone: 02-2019-3529
email: hanesth@yuhs.ac
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gangnam Severance Hospital
investigator full name: Dong Woo Han
investigator title: Professor
mesh term: Prostatic Neoplasms
sharing ipd: No