<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/NCT03026530</url>
  </required_header>
  <id_info>
    <org_study_id>Region Östergötland</org_study_id>
    <nct_id>NCT03026530</nct_id>
  </id_info>
  <brief_title>Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery</brief_title>
  <official_title>Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Östergötland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Östergötland</source>
  <brief_summary>
    <textblock>
      The purpose of this prospective, blinded, randomized clinical trial is to investigate whether&#xD;
      a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce overall&#xD;
      postoperative pain and nausea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>4, 12, 24, 36 and 48 hours after surgery</time_frame>
    <description>A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Nausea</measure>
    <time_frame>4, 12, 24, 36 and 48 hours after surgery</time_frame>
    <description>A questionnaire was used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. The questionnaire involved a numeric rating scale (NRS) from 0 to 10, where 0 signified no nausea, and10 the worst imaginable nausea.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Postoperative Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Pulmonary recruitment maneuver</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ordinary ventilation at the end of laparoscopic bariatric surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary recruitment maneuver</intervention_name>
    <description>The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.</description>
    <arm_group_label>Pulmonary recruitment maneuver</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic bariatric surgery</intervention_name>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Pulmonary recruitment maneuver</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ventilator</intervention_name>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Pulmonary recruitment maneuver</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective laparoscopic bariatric surgery (LBS)&#xD;
&#xD;
          -  American Society of Anaesthesiologists (ASA) physical status classification I-II (with&#xD;
             the exception of body mass index over 35 kg/m2)&#xD;
&#xD;
          -  written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  conversion to open surgery&#xD;
&#xD;
          -  complication, Clavien-Dindo grade ≥ II&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebba Kihlstedt Pasquier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vrinnevi Hospital, Norrköping, Sweden</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ellen Andersson, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Vrinnevi Hospital, Norrköping, Sweden</affiliation>
  </overall_official>
  <results_reference>
    <citation>Pasquier EK, Andersson E. Pulmonary recruitment maneuver reduces pain after laparoscopic bariatric surgery: a randomized controlled clinical trial. Surg Obes Relat Dis. 2018 Mar;14(3):386-392. doi: 10.1016/j.soard.2017.11.017. Epub 2017 Nov 22.</citation>
    <PMID>29290563</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <results_first_submitted>September 3, 2018</results_first_submitted>
  <results_first_submitted_qc>December 4, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 5, 2018</results_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Östergötland</investigator_affiliation>
    <investigator_full_name>Ebba Kihlstedt Pasquier</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>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pulmonary Recruitment Maneuver</title>
          <description>Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.&#xD;
Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.&#xD;
Laparoscopic bariatric surgery&#xD;
Ventilator</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Ordinary ventilation at the end of laparoscopic bariatric surgery.&#xD;
Laparoscopic bariatric surgery&#xD;
Ventilator</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="71"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="24"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pulmonary Recruitment Maneuver</title>
          <description>Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.&#xD;
Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.&#xD;
Laparoscopic bariatric surgery&#xD;
Ventilator</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Ordinary ventilation at the end of laparoscopic bariatric surgery.&#xD;
Laparoscopic bariatric surgery&#xD;
Ventilator</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="79"/>
            <count group_id="B2" value="71"/>
            <count group_id="B3" value="150"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="79"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47" lower_limit="34" upper_limit="53"/>
                    <measurement group_id="B2" value="44" lower_limit="32" upper_limit="51"/>
                    <measurement group_id="B3" value="46" lower_limit="33" upper_limit="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="79"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="121"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Sweden</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="79"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="79"/>
                    <count group_id="B2" value="71"/>
                    <count group_id="B3" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38" lower_limit="36" upper_limit="42"/>
                    <measurement group_id="B2" value="38" lower_limit="36" upper_limit="42"/>
                    <measurement group_id="B3" value="38" lower_limit="36" upper_limit="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postoperative Pain</title>
        <description>A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain.</description>
        <time_frame>4, 12, 24, 36 and 48 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulmonary Recruitment Maneuver</title>
            <description>Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.&#xD;
Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.&#xD;
Laparoscopic bariatric surgery&#xD;
Ventilator</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Ordinary ventilation at the end of laparoscopic bariatric surgery.&#xD;
Laparoscopic bariatric surgery&#xD;
Ventilator</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Pain</title>
          <description>A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4 hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="3" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="O2" value="3" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="2.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Nausea</title>
        <description>A questionnaire was used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. The questionnaire involved a numeric rating scale (NRS) from 0 to 10, where 0 signified no nausea, and10 the worst imaginable nausea.</description>
        <time_frame>4, 12, 24, 36 and 48 hours after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pulmonary Recruitment Maneuver</title>
            <description>Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.&#xD;
Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.&#xD;
Laparoscopic bariatric surgery&#xD;
Ventilator</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Ordinary ventilation at the end of laparoscopic bariatric surgery.&#xD;
Laparoscopic bariatric surgery&#xD;
Ventilator</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Nausea</title>
          <description>A questionnaire was used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. The questionnaire involved a numeric rating scale (NRS) from 0 to 10, where 0 signified no nausea, and10 the worst imaginable nausea.</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="71"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4 hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NRS 12 hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>36 hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>48 hr</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Pulmonary Recruitment Maneuver</title>
          <description>Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.&#xD;
Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.&#xD;
Laparoscopic bariatric surgery&#xD;
Ventilator</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Ordinary ventilation at the end of laparoscopic bariatric surgery.&#xD;
Laparoscopic bariatric surgery&#xD;
Ventilator</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Kihlstedt Pasquier</name_or_title>
      <organization>Region Ostergotland</organization>
      <phone>0046101041000</phone>
      <email>ebba.kihlstedt.pasquier@regionostergotland.se</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03026530
org study id: Region Östergötland
nct id: NCT03026530
lead sponsor: 
The purpose of this prospective, blinded, randomized clinical trial is to investigate whether
      a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce overall
      postoperative pain and nausea.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Postoperative Pain
time frame: 4, 12, 24, 36 and 48 hours after surgery
description: A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain.
measure: Postoperative Nausea
time frame: 4, 12, 24, 36 and 48 hours after surgery
description: A questionnaire was used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. The questionnaire involved a numeric rating scale (NRS) from 0 to 10, where 0 signified no nausea, and10 the worst imaginable nausea.
arm group label: Pulmonary recruitment maneuver
arm group type: Experimental
description: Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
arm group label: Control group
arm group type: Active Comparator
description: Ordinary ventilation at the end of laparoscopic bariatric surgery.
intervention type: Procedure
intervention name: Pulmonary recruitment maneuver
description: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.
arm group label: Pulmonary recruitment maneuver
intervention type: Procedure
intervention name: Laparoscopic bariatric surgery
arm group label: Control group
arm group label: Pulmonary recruitment maneuver
intervention type: Device
intervention name: Ventilator
arm group label: Control group
arm group label: Pulmonary recruitment maneuver
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ebba Kihlstedt Pasquier, MD
role: Principal Investigator
affiliation: Vrinnevi Hospital, Norrköping, Sweden
last name: Ellen Andersson, MD, PhD
role: Study Chair
affiliation: Vrinnevi Hospital, Norrköping, Sweden
citation: Pasquier EK, Andersson E. Pulmonary recruitment maneuver reduces pain after laparoscopic bariatric surgery: a randomized controlled clinical trial. Surg Obes Relat Dis. 2018 Mar;14(3):386-392. doi: 10.1016/j.soard.2017.11.017. Epub 2017 Nov 22.
PMID: 29290563
responsible party type: Principal Investigator
investigator affiliation: Region Östergötland
investigator full name: Ebba Kihlstedt Pasquier
investigator title: Principal Investigator
mesh term: Nausea
mesh term: Vomiting
mesh term: Pain, Postoperative
mesh term: Postoperative Nausea and Vomiting
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 