<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/NCT04468698</url>
  </required_header>
  <id_info>
    <org_study_id>VoIPP</org_study_id>
    <nct_id>NCT04468698</nct_id>
  </id_info>
  <brief_title>Intra-Abdominal Pressure Effect on Intra-Abdominal Volume and Airway Pressures During Laparoscopy</brief_title>
  <official_title>Intra-Abdominal Pressure Effect on Intra-Abdominal Volume and Airway Pressures During Pneumoperitoneum Insufflation - a Patient-Level Meta-Analysis of Three Randomized Clinical Trials</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario La Fe</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario La Fe</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>
      During pneumoperitoneum insufflation the insufflated gas increase intra-abdominal pressure.&#xD;
      The generated pressure can lead to a different increase in volume depending on the abdominal&#xD;
      cavity and patients' characteristics.&#xD;
&#xD;
      The primary objective is to determine the relationship between intraabdominal pressure (IAP)&#xD;
      and intraabdominal volume (IAV) during pneumoperitoneum insufflation. The secondary objective&#xD;
      is to determine the rate of abdominal-thoracic transmission (ATT) assessing the correlation&#xD;
      between IAP and respiratory driving pressure (ΔPRS).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Intraabdominal volume</measure>
    <time_frame>During pneumoperitoneum insufflation before surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Driving pressure</measure>
    <time_frame>During pneumoperitoneum insufflation before surgery</time_frame>
    <description>This is the pressure that exert a stress on the respiratory system during mechanical ventilation. It is calculated by subtracting the positive endexpiratory pressure from plateau pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plateau pressure</measure>
    <time_frame>During pneumoperitoneum insufflation before surgery</time_frame>
    <description>This is the pressure in the airway during the mechanical venitilation inspiratory pause time</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">204</enrollment>
  <condition>Surgery</condition>
  <condition>Pneumoperitoneum</condition>
  <condition>Intra Abdominal Pressure</condition>
  <arm_group>
    <arm_group_label>Global cohort</arm_group_label>
    <description>A global cohort is built merging data from three studies</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peritoneum insufflation</intervention_name>
    <description>Before surgery pneumoperitoneum is established by insufflating gas into the abdomen. Intraabdominal pressure (IAP) is set to 15 mmHg for initial abdominal stretching and then decreased in a stepwise manner down until 8 mmHg.</description>
    <arm_group_label>Global cohort</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing pneumoperitoenum insufflation during general anesthesia and mechanical&#xD;
        venitlation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled one of the three studies (IPPCollapse I, II or III).&#xD;
&#xD;
          -  underwent an initial insufflation procedure with a stepwise change in intraabdominal&#xD;
             pressure to record Intraabdominal volume&#xD;
&#xD;
          -  data from insufflation at 5 cmH2O of PEEP&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital la Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario La Fe</investigator_affiliation>
    <investigator_full_name>Oscar Diaz-Cambronero</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumoperitoneum</mesh_term>
  </condition_browse>
  <!-- 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/NCT04468698
org study id: VoIPP
nct id: NCT04468698
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
During pneumoperitoneum insufflation the insufflated gas increase intra-abdominal pressure.
      The generated pressure can lead to a different increase in volume depending on the abdominal
      cavity and patients' characteristics.

      The primary objective is to determine the relationship between intraabdominal pressure (IAP)
      and intraabdominal volume (IAV) during pneumoperitoneum insufflation. The secondary objective
      is to determine the rate of abdominal-thoracic transmission (ATT) assessing the correlation
      between IAP and respiratory driving pressure (ΔPRS).
observational model: Cohort
time perspective: Retrospective
measure: Intraabdominal volume
time frame: During pneumoperitoneum insufflation before surgery
measure: Driving pressure
time frame: During pneumoperitoneum insufflation before surgery
description: This is the pressure that exert a stress on the respiratory system during mechanical ventilation. It is calculated by subtracting the positive endexpiratory pressure from plateau pressure
measure: Plateau pressure
time frame: During pneumoperitoneum insufflation before surgery
description: This is the pressure in the airway during the mechanical venitilation inspiratory pause time
arm group label: Global cohort
description: A global cohort is built merging data from three studies
intervention type: Other
intervention name: Peritoneum insufflation
description: Before surgery pneumoperitoneum is established by insufflating gas into the abdomen. Intraabdominal pressure (IAP) is set to 15 mmHg for initial abdominal stretching and then decreased in a stepwise manner down until 8 mmHg.
arm group label: Global cohort
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital Universitario La Fe
investigator full name: Oscar Diaz-Cambronero
investigator title: Principal Investigator
mesh term: Pneumoperitoneum