<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/NCT04502420</url>
  </required_header>
  <id_info>
    <org_study_id>2018-223-31M</org_study_id>
    <nct_id>NCT04502420</nct_id>
  </id_info>
  <brief_title>Lung Function After Abdominal Surgery</brief_title>
  <official_title>Hypoxia, Lung Function and Diffusion Capacity After Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umeå University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Umeå University</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>
      The study aims to investigate changes in lung function and diffusion capacity for carbon&#xD;
      monoxide after open and minimally invasive abdominal surgery and whether such changes can&#xD;
      explain hypoxia after surgery.&#xD;
&#xD;
      Inclusion: Patients undergoing surgery for abdominal surgery&#xD;
&#xD;
      Exclusion: Dementia or cognitive impairment that makes it impossible to participate in&#xD;
      studies.&#xD;
&#xD;
      Investigation: The day before surgery and the day after surgery&#xD;
&#xD;
      Primary outcome measures:&#xD;
&#xD;
        -  Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion&#xD;
           capacity for carbon monoxide.&#xD;
&#xD;
        -  PaO2, PaCO2 and oxygen saturation (blood gas)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. People at particular risk&#xD;
      for postoperative pulmonary complications including severe hypoxia are those who undergo&#xD;
      abdominal surgery, emergency surgery or have a respiratory failure due to chronic lung&#xD;
      disease including obstructive sleep apnea. The cause of postoperative restrictive lung&#xD;
      function and hypoxia is unknown. Previous studies report that PaO2 decreases by an average of&#xD;
      2 kPa after abdominal surgery, while PaCO2 is unchanged and vital capacity decreases by 35%.&#xD;
&#xD;
      The study aims to investigate changes in lung function and diffusion capacity for carbon&#xD;
      monoxide after open and minimally invasive abdominal surgery and whether such changes can&#xD;
      explain hypoxia after surgery.&#xD;
&#xD;
      Design: Prospective cohort study&#xD;
&#xD;
      Inclusion: Patients undergoing surgery for abdominal surgery&#xD;
&#xD;
      Exclusion: Dementia or cognitive impairment that makes it impossible to participate in&#xD;
      studies.&#xD;
&#xD;
      Method: The day before surgery and the day after surgery: Lung function (Vital capacity and&#xD;
      FEV1) using box and diffusion capacity measurements and blood gas measurement&#xD;
&#xD;
      Primary outcome measures:&#xD;
&#xD;
        -  Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion&#xD;
           capacity for carbon monoxide.&#xD;
&#xD;
        -  PaO2, PaCO2 and oxygen saturation (blood gas) Other variables examined: age, sex,&#xD;
           height, weight, type of surgery, type of anesthesia, smoking status, length of surgery,&#xD;
           previously known lung disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2020</start_date>
  <completion_date type="Actual">October 17, 2021</completion_date>
  <primary_completion_date type="Actual">October 17, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diffusion capacity for carbon monoxide (DLCO)</measure>
    <time_frame>Change from baseline (the day before surgery) to postoperative day 1 or 2</time_frame>
    <description>Change in DLCO</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vital capacity (VC)</measure>
    <time_frame>Change from baseline (the day before surgery) to postoperative day 1 or 2</time_frame>
    <description>Change in VC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory volume (FEV1)</measure>
    <time_frame>Change from baseline (the day before surgery) to postoperative day 1 or 2</time_frame>
    <description>Change in FEV1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial PO2</measure>
    <time_frame>Change from baseline (the day before surgery) to postoperative day 1 or 2</time_frame>
    <description>Change in arterial PO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial PCO2</measure>
    <time_frame>Change from baseline (the day before surgery) to postoperative day 1 or 2</time_frame>
    <description>Change in arterial PCO2</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Lung Function</condition>
  <condition>Postoperative Complications</condition>
  <condition>Abdominal Surgery</condition>
  <arm_group>
    <arm_group_label>Abdominal surgery</arm_group_label>
    <description>People who to be operated in the abdomen are investigated before and after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Lung function before and after surgery</intervention_name>
    <description>A diagnostic test</description>
    <arm_group_label>Abdominal surgery</arm_group_label>
    <other_name>Diffusion capacity and arterial blood gas before and after surgery.</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients of 18 years old or olderundergoing abdominal surgery at department of Surgery,&#xD;
        Urology and Gynecologi Umeå University hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (18 years old and older) scheduled for surgery in the abdomen at&#xD;
             department of Surgery, Urology and Gynecologi, Umeå University hospital.&#xD;
&#xD;
          -  Must be able to perform a lung function test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Dementia or severe cognitive impairment&#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>Karl A Franklin, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inst Surgical and periopertive sciences, Umeå university, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept surgery,</name>
      <address>
        <city>Umeå</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>January 21, 2023</last_update_submitted>
  <last_update_submitted_qc>January 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umeå University</investigator_affiliation>
    <investigator_full_name>Karl A Franklin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Lung function</keyword>
  <keyword>Diffusion capacity</keyword>
  <keyword>Postoperative complications</keyword>
  <keyword>Abdominal surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We plan to share IPD if possible according to Swedish legislation</ipd_description>
  </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/NCT04502420
org study id: 2018-223-31M
nct id: NCT04502420
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to investigate changes in lung function and diffusion capacity for carbon
      monoxide after open and minimally invasive abdominal surgery and whether such changes can
      explain hypoxia after surgery.

      Inclusion: Patients undergoing surgery for abdominal surgery

      Exclusion: Dementia or cognitive impairment that makes it impossible to participate in
      studies.

      Investigation: The day before surgery and the day after surgery

      Primary outcome measures:

        -  Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion
           capacity for carbon monoxide.

        -  PaO2, PaCO2 and oxygen saturation (blood gas)
Postoperative hypoxia complicates 30% - 50% of abdominal surgeries. People at particular risk
      for postoperative pulmonary complications including severe hypoxia are those who undergo
      abdominal surgery, emergency surgery or have a respiratory failure due to chronic lung
      disease including obstructive sleep apnea. The cause of postoperative restrictive lung
      function and hypoxia is unknown. Previous studies report that PaO2 decreases by an average of
      2 kPa after abdominal surgery, while PaCO2 is unchanged and vital capacity decreases by 35%.

      The study aims to investigate changes in lung function and diffusion capacity for carbon
      monoxide after open and minimally invasive abdominal surgery and whether such changes can
      explain hypoxia after surgery.

      Design: Prospective cohort study

      Inclusion: Patients undergoing surgery for abdominal surgery

      Exclusion: Dementia or cognitive impairment that makes it impossible to participate in
      studies.

      Method: The day before surgery and the day after surgery: Lung function (Vital capacity and
      FEV1) using box and diffusion capacity measurements and blood gas measurement

      Primary outcome measures:

        -  Pulmonary function test with dynamic spirometry (Vital capacity, FEV1) and diffusion
           capacity for carbon monoxide.

        -  PaO2, PaCO2 and oxygen saturation (blood gas) Other variables examined: age, sex,
           height, weight, type of surgery, type of anesthesia, smoking status, length of surgery,
           previously known lung disease.
observational model: Cohort
time perspective: Prospective
measure: Diffusion capacity for carbon monoxide (DLCO)
time frame: Change from baseline (the day before surgery) to postoperative day 1 or 2
description: Change in DLCO
measure: Vital capacity (VC)
time frame: Change from baseline (the day before surgery) to postoperative day 1 or 2
description: Change in VC
measure: Forced expiratory volume (FEV1)
time frame: Change from baseline (the day before surgery) to postoperative day 1 or 2
description: Change in FEV1
measure: Arterial PO2
time frame: Change from baseline (the day before surgery) to postoperative day 1 or 2
description: Change in arterial PO2
measure: Arterial PCO2
time frame: Change from baseline (the day before surgery) to postoperative day 1 or 2
description: Change in arterial PCO2
arm group label: Abdominal surgery
description: People who to be operated in the abdomen are investigated before and after surgery.
intervention type: Diagnostic Test
intervention name: Lung function before and after surgery
description: A diagnostic test
arm group label: Abdominal surgery
other name: Diffusion capacity and arterial blood gas before and after surgery.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karl A Franklin, Prof
role: Principal Investigator
affiliation: Inst Surgical and periopertive sciences, Umeå university, Sweden
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Umeå University
investigator full name: Karl A Franklin
investigator title: Professor
mesh term: Postoperative Complications
sharing ipd: No
ipd description: We plan to share IPD if possible according to Swedish legislation