<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/NCT03256396</url>
  </required_header>
  <id_info>
    <org_study_id>253/2560(EC3)</org_study_id>
    <nct_id>NCT03256396</nct_id>
  </id_info>
  <brief_title>Intraoperative PEEP Setting During Laparoscopic Gynecologic Surgery</brief_title>
  <official_title>Intraoperative Positive End-Expiratory Pressure Setting Guided By Esophageal Pressure Measurement in Patients Undergoing Laparoscopic Gynecologic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The creation of pneumoperitoneum during laparoscopic surgery can have significant effects on&#xD;
      the respiratory system including decreased respiratory system compliance, decreased vital&#xD;
      capacity and functional residual capacity and atelectasis formation. Intraoperative&#xD;
      mechanical ventilation, especially setting of positive end-expiratory pressure (PEEP) has an&#xD;
      important role in respiratory management during laparoscopic surgery. The aim of this study&#xD;
      is to determine whether setting of PEEP guided by measurement of pleural pressure would&#xD;
      improve oxygenation and respiratory system compliance during laparoscopic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As minimally invasive procedure with numerous advantages compared with open surgery,&#xD;
      laparoscopic surgery has been substantially performed worldwide. The creation of&#xD;
      pneumoperitoneum during laparoscopic surgery, however, can have significant effects on the&#xD;
      respiratory system including decreased respiratory system compliance, decreased vital&#xD;
      capacity and functional residual capacity and atelectasis formation. These pathophysiologic&#xD;
      changes may put patients at risk of postoperative pulmonary complications. Therefore,&#xD;
      intraoperative mechanical ventilation, especially setting of positive end-expiratory pressure&#xD;
      (PEEP) has an important role in respiratory management during laparoscopic surgery.&#xD;
      Nevertheless, there is no consensus on the optimal PEEP level and the best method to set PEEP&#xD;
      during laparoscopic surgery. In patients with acute respiratory distress syndrome, PEEP set&#xD;
      according to pleural pressure measured by using esophageal balloon catheter significantly has&#xD;
      beneficial effects in terms of oxygenation, compliance and possible mortality. The aim of&#xD;
      this study is to determine whether setting of PEEP guided by measurement of pleural pressure&#xD;
      would improve oxygenation and respiratory system compliance during laparoscopic surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2018</start_date>
  <completion_date type="Actual">December 28, 2018</completion_date>
  <primary_completion_date type="Actual">June 29, 2018</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in PaO2 between Group E and Group C</measure>
    <time_frame>At 15 minutes after initiation of pneumoperitoneum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in PaO2 between Group E and Group C</measure>
    <time_frame>At 60 minutes after initiation of pneumoperitoneum</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Difference in PaO2 between Group E and Group C</measure>
    <time_frame>At 30 minutes after arrival in recovery room</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in compliance of respiratory system between Group E and Group C</measure>
    <time_frame>At 15 minutes and 60 minutes after initiation of pneumoperitoneum, and 30 minutes after arrival in recovery room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in alveolar dead space to tidal volume ratio between Group E and Group C</measure>
    <time_frame>At 15 minutes and 60 minutes after initiation of pneumoperitoneum, and 30 minutes after arrival in recovery room</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in hemodynamics between Group E and Group C</measure>
    <time_frame>At 15 minutes and 60 minutes after initiation of pneumoperitoneum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of thoracoabdominal transmission of intraabdominal pressure</measure>
    <time_frame>At 15 minutes and 60 minutes after initiation of pneumoperitoneum</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse respiratory events</measure>
    <time_frame>During 72 hours postoperatively or until discharge from hospital</time_frame>
    <description>Adverse respiratory events define as requirement of oxygen supplement after discharge from the recovery room, episodes of desaturation (SpO2 of less than 90%), now-onset respiratory infection, new infiltration on chest radiograph, or respiratory failure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Up to 30 days after the operation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Positive-Pressure Respiration/Methods</condition>
  <condition>Esophagus/Physiopathology</condition>
  <condition>Pleura/Physiopathology</condition>
  <condition>Gynecologic Surgical Procedures</condition>
  <condition>Laparoscopy</condition>
  <condition>Humans</condition>
  <condition>Female</condition>
  <arm_group>
    <arm_group_label>Group E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PEEP set according to esophageal pressure measured</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>PEEP set at 5 cm H2O</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PEEP setting based on esophageal pressure measured</intervention_name>
    <description>PEEP is set on the basis of esophageal pressure measurement with the aim to maintain transpulmonary pressure during expiration between 0 and 5 cmH2O</description>
    <arm_group_label>Group E</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with age of equal or more than 18 years old undergoing laparoscopic&#xD;
             gynecologic surgery with anticipated surgical duration of more than 2 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with ASA physical status of equal or more than 3&#xD;
&#xD;
          -  Patients with significant cardiovascular or respiratory diseases&#xD;
&#xD;
          -  Patients with significant pathological lesion in pharynx and esophagus that preclude&#xD;
             placement of esophageal balloon catheter&#xD;
&#xD;
          -  Patients with contraindications for PEEP titration such as increased intracranial&#xD;
             pressure or unstable hemodynamic&#xD;
&#xD;
          -  Patients with arrhythmias&#xD;
&#xD;
          -  Patients who refuse to provide written informed consent&#xD;
&#xD;
          -  Patients undergoing surgery with duration of less than 2 hours&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annop Piriyapatsom, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Siriraj Hospital</name>
      <address>
        <city>Bangkoknoi</city>
        <state>Bangkok</state>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <citation>Pelosi P, Foti G, Cereda M, Vicardi P, Gattinoni L. Effects of carbon dioxide insufflation for laparoscopic cholecystectomy on the respiratory system. Anaesthesia. 1996 Aug;51(8):744-9. doi: 10.1111/j.1365-2044.1996.tb07888.x.</citation>
    <PMID>8795317</PMID>
  </reference>
  <reference>
    <citation>Rauh R, Hemmerling TM, Rist M, Jacobi KE. Influence of pneumoperitoneum and patient positioning on respiratory system compliance. J Clin Anesth. 2001 Aug;13(5):361-5. doi: 10.1016/s0952-8180(01)00286-0.</citation>
    <PMID>11498317</PMID>
  </reference>
  <reference>
    <citation>Gallart L, Canet J. Post-operative pulmonary complications: Understanding definitions and risk assessment. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):315-30. doi: 10.1016/j.bpa.2015.10.004. Epub 2015 Oct 22. Erratum In: Best Pract Res Clin Anaesthesiol. 2016 Mar;30(1):121-5.</citation>
    <PMID>26643097</PMID>
  </reference>
  <reference>
    <citation>Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. doi: 10.1016/j.bpa.2010.02.002.</citation>
    <PMID>20608559</PMID>
  </reference>
  <reference>
    <citation>Park SJ, Kim BG, Oh AH, Han SH, Han HS, Ryu JH. Effects of intraoperative protective lung ventilation on postoperative pulmonary complications in patients with laparoscopic surgery: prospective, randomized and controlled trial. Surg Endosc. 2016 Oct;30(10):4598-606. doi: 10.1007/s00464-016-4797-x. Epub 2016 Feb 19.</citation>
    <PMID>26895920</PMID>
  </reference>
  <reference>
    <citation>Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.</citation>
    <PMID>19001507</PMID>
  </reference>
  <results_reference>
    <citation>Meininger D, Byhahn C, Mierdl S, Westphal K, Zwissler B. Positive end-expiratory pressure improves arterial oxygenation during prolonged pneumoperitoneum. Acta Anaesthesiol Scand. 2005 Jul;49(6):778-83. doi: 10.1111/j.1399-6576.2005.00713.x.</citation>
    <PMID>15954959</PMID>
  </results_reference>
  <results_reference>
    <citation>Maracaja-Neto LF, Vercosa N, Roncally AC, Giannella A, Bozza FA, Lessa MA. Beneficial effects of high positive end-expiratory pressure in lung respiratory mechanics during laparoscopic surgery. Acta Anaesthesiol Scand. 2009 Feb;53(2):210-7. doi: 10.1111/j.1399-6576.2008.01826.x.</citation>
    <PMID>19175578</PMID>
  </results_reference>
  <results_reference>
    <citation>Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.</citation>
    <PMID>23196259</PMID>
  </results_reference>
  <results_reference>
    <citation>Spadaro S, Karbing DS, Mauri T, Marangoni E, Mojoli F, Valpiani G, Carrieri C, Ragazzi R, Verri M, Rees SE, Volta CA. Effect of positive end-expiratory pressure on pulmonary shunt and dynamic compliance during abdominal surgery. Br J Anaesth. 2016 Jun;116(6):855-61. doi: 10.1093/bja/aew123.</citation>
    <PMID>27199317</PMID>
  </results_reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 21, 2019</last_update_submitted>
  <last_update_submitted_qc>August 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mahidol University</investigator_affiliation>
    <investigator_full_name>Annop Piriyapatsom, MD</investigator_full_name>
    <investigator_title>Lecturer, Department of Anesthesiology, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Intraoperative mechanical ventilation</keyword>
  <keyword>Positive-end expiratory pressure</keyword>
  <keyword>Esophageal pressure</keyword>
  <keyword>Transpulmonary pressure</keyword>
  <keyword>Laparoscopic gynecologic surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pathologic Processes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03256396/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03256396
org study id: 253/2560(EC3)
nct id: NCT03256396
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The creation of pneumoperitoneum during laparoscopic surgery can have significant effects on
      the respiratory system including decreased respiratory system compliance, decreased vital
      capacity and functional residual capacity and atelectasis formation. Intraoperative
      mechanical ventilation, especially setting of positive end-expiratory pressure (PEEP) has an
      important role in respiratory management during laparoscopic surgery. The aim of this study
      is to determine whether setting of PEEP guided by measurement of pleural pressure would
      improve oxygenation and respiratory system compliance during laparoscopic surgery.
As minimally invasive procedure with numerous advantages compared with open surgery,
      laparoscopic surgery has been substantially performed worldwide. The creation of
      pneumoperitoneum during laparoscopic surgery, however, can have significant effects on the
      respiratory system including decreased respiratory system compliance, decreased vital
      capacity and functional residual capacity and atelectasis formation. These pathophysiologic
      changes may put patients at risk of postoperative pulmonary complications. Therefore,
      intraoperative mechanical ventilation, especially setting of positive end-expiratory pressure
      (PEEP) has an important role in respiratory management during laparoscopic surgery.
      Nevertheless, there is no consensus on the optimal PEEP level and the best method to set PEEP
      during laparoscopic surgery. In patients with acute respiratory distress syndrome, PEEP set
      according to pleural pressure measured by using esophageal balloon catheter significantly has
      beneficial effects in terms of oxygenation, compliance and possible mortality. The aim of
      this study is to determine whether setting of PEEP guided by measurement of pleural pressure
      would improve oxygenation and respiratory system compliance during laparoscopic surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Difference in PaO2 between Group E and Group C
time frame: At 15 minutes after initiation of pneumoperitoneum
measure: Difference in PaO2 between Group E and Group C
time frame: At 60 minutes after initiation of pneumoperitoneum
measure: Difference in PaO2 between Group E and Group C
time frame: At 30 minutes after arrival in recovery room
measure: Difference in compliance of respiratory system between Group E and Group C
time frame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum, and 30 minutes after arrival in recovery room
measure: Difference in alveolar dead space to tidal volume ratio between Group E and Group C
time frame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum, and 30 minutes after arrival in recovery room
measure: Difference in hemodynamics between Group E and Group C
time frame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum
measure: Proportion of thoracoabdominal transmission of intraabdominal pressure
time frame: At 15 minutes and 60 minutes after initiation of pneumoperitoneum
measure: Adverse respiratory events
time frame: During 72 hours postoperatively or until discharge from hospital
description: Adverse respiratory events define as requirement of oxygen supplement after discharge from the recovery room, episodes of desaturation (SpO2 of less than 90%), now-onset respiratory infection, new infiltration on chest radiograph, or respiratory failure.
measure: Length of hospital stay
time frame: Up to 30 days after the operation
arm group label: Group E
arm group type: Experimental
description: PEEP set according to esophageal pressure measured
arm group label: Group C
arm group type: No Intervention
description: PEEP set at 5 cm H2O
intervention type: Procedure
intervention name: PEEP setting based on esophageal pressure measured
description: PEEP is set on the basis of esophageal pressure measurement with the aim to maintain transpulmonary pressure during expiration between 0 and 5 cmH2O
arm group label: Group E
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Annop Piriyapatsom, MD
role: Principal Investigator
affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
facility: 
country: Thailand
citation: Pelosi P, Foti G, Cereda M, Vicardi P, Gattinoni L. Effects of carbon dioxide insufflation for laparoscopic cholecystectomy on the respiratory system. Anaesthesia. 1996 Aug;51(8):744-9. doi: 10.1111/j.1365-2044.1996.tb07888.x.
PMID: 8795317
citation: Rauh R, Hemmerling TM, Rist M, Jacobi KE. Influence of pneumoperitoneum and patient positioning on respiratory system compliance. J Clin Anesth. 2001 Aug;13(5):361-5. doi: 10.1016/s0952-8180(01)00286-0.
PMID: 11498317
citation: Gallart L, Canet J. Post-operative pulmonary complications: Understanding definitions and risk assessment. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):315-30. doi: 10.1016/j.bpa.2015.10.004. Epub 2015 Oct 22. Erratum In: Best Pract Res Clin Anaesthesiol. 2016 Mar;30(1):121-5.
PMID: 26643097
citation: Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. doi: 10.1016/j.bpa.2010.02.002.
PMID: 20608559
citation: Park SJ, Kim BG, Oh AH, Han SH, Han HS, Ryu JH. Effects of intraoperative protective lung ventilation on postoperative pulmonary complications in patients with laparoscopic surgery: prospective, randomized and controlled trial. Surg Endosc. 2016 Oct;30(10):4598-606. doi: 10.1007/s00464-016-4797-x. Epub 2016 Feb 19.
PMID: 26895920
citation: Talmor D, Sarge T, Malhotra A, O'Donnell CR, Ritz R, Lisbon A, Novack V, Loring SH. Mechanical ventilation guided by esophageal pressure in acute lung injury. N Engl J Med. 2008 Nov 13;359(20):2095-104. doi: 10.1056/NEJMoa0708638. Epub 2008 Nov 11.
PMID: 19001507
citation: Meininger D, Byhahn C, Mierdl S, Westphal K, Zwissler B. Positive end-expiratory pressure improves arterial oxygenation during prolonged pneumoperitoneum. Acta Anaesthesiol Scand. 2005 Jul;49(6):778-83. doi: 10.1111/j.1399-6576.2005.00713.x.
PMID: 15954959
citation: Maracaja-Neto LF, Vercosa N, Roncally AC, Giannella A, Bozza FA, Lessa MA. Beneficial effects of high positive end-expiratory pressure in lung respiratory mechanics during laparoscopic surgery. Acta Anaesthesiol Scand. 2009 Feb;53(2):210-7. doi: 10.1111/j.1399-6576.2008.01826.x.
PMID: 19175578
citation: Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10.
PMID: 23196259
citation: Spadaro S, Karbing DS, Mauri T, Marangoni E, Mojoli F, Valpiani G, Carrieri C, Ragazzi R, Verri M, Rees SE, Volta CA. Effect of positive end-expiratory pressure on pulmonary shunt and dynamic compliance during abdominal surgery. Br J Anaesth. 2016 Jun;116(6):855-61. doi: 10.1093/bja/aew123.
PMID: 27199317
responsible party type: Principal Investigator
investigator affiliation: Mahidol University
investigator full name: Annop Piriyapatsom, MD
investigator title: Lecturer, Department of Anesthesiology, Principal Investigator
mesh term: Pathologic Processes
sharing ipd: No
provided document: 