<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/NCT04507594</url>
  </required_header>
  <id_info>
    <org_study_id>DiaphragmaticDysfunction</org_study_id>
    <nct_id>NCT04507594</nct_id>
  </id_info>
  <brief_title>Measurement of Diaphragmatic Dysfunction After Thoracic Surgery</brief_title>
  <official_title>Measurement of Diaphragmatic Dysfunction in Patients Undergoing Thoracic Resection Surgery for Lung- or Esophageal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</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>
      This study aims to measure diaphragmatic dysfunction with ultrasonography and nerve&#xD;
      stimulation of the phrenicus nerve, in patients undergoing thoracic surgery for lung and&#xD;
      esophageal cancer, and correlate measures of diaphramatic function to clinical postoperative&#xD;
      endpoints.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 6, 2020</start_date>
  <completion_date type="Actual">October 30, 2022</completion_date>
  <primary_completion_date type="Actual">October 1, 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>Change in excursion of the diaphragm</measure>
    <time_frame>Prior to surgery to 14 days after surgery</time_frame>
    <description>Ultrasonographic measure with M-mode of Diaphragmatic Excursion on right hemidiaphragm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ultrasonographic measure of the difference in Intrathoracic Area</measure>
    <time_frame>Prior to surgery to 14 days after surgery</time_frame>
    <description>Intrathoracic Area is measured at inspiration and expiration to calculate the difference in Intrathoracic Area during breathing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diaphragmatic Thickening Fraction</measure>
    <time_frame>Prior to surgery to 14 days after surgery</time_frame>
    <description>Ultrasonographic measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intercostal Muscle Thickening Fraction</measure>
    <time_frame>Prior to surgery to 14 days after surgery</time_frame>
    <description>Ultrasonographic measurement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in forced expired volume within the first second (FEV1)</measure>
    <time_frame>Prior to surgery to 14 days after surgery</time_frame>
    <description>Spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in forced vital capacity (FEV)</measure>
    <time_frame>Prior to surgery to 14 days after surgery</time_frame>
    <description>Spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in peak flow</measure>
    <time_frame>Prior to surgery to 14 days after surgery</time_frame>
    <description>Spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nerve</measure>
    <time_frame>Prior to surgery to 14 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Electromyographic measure of Latency of Diaphragmatic Response after stimulating the phrenic nerve</measure>
    <time_frame>Prior to surgery to 14 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 6 Minutes Walk Test</measure>
    <time_frame>Prior to surgery to 14 days after surgery</time_frame>
    <description>Maximum Walking Distance within 6 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in visual analogue scale score</measure>
    <time_frame>Prior to surgery to 14 days after surgery</time_frame>
    <description>Scoring system for subjective sensation of pain ranging from 0 to 10. Higher numbers signify higher pain sensations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulated Opiod Use after Surgery</measure>
    <time_frame>Prior to surgery to 14 days after surgery</time_frame>
    <description>Morphine equivalents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Pulmonary Complications</measure>
    <time_frame>Prior to surgery to 30 days after surgery</time_frame>
    <description>Comprising:&#xD;
Pneumonia&#xD;
Atelectasis&#xD;
Bronchospasm&#xD;
Hypoxemia&#xD;
Severe Hypoxemia&#xD;
Pleural Effusion 1 &gt; cm&#xD;
Pneumothorax&#xD;
CPAP or NIV required after 1. postoperative day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission days at the Intensive Care Unit after Surgery</measure>
    <time_frame>Prior to surgery to 60 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Admissions after Discharge from the Surgical Department</measure>
    <time_frame>Prior to surgery to 60 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulated Admission Days at any Hospital</measure>
    <time_frame>Prior to surgery to 60 days after surgery</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Diaphragm Injury</condition>
  <condition>Phrenic Nerve Paralysis</condition>
  <condition>Thoracic Cancer</condition>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Patients undergoing Thoracic Surgery</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lung lobectomy OR esophagus cancer resection</intervention_name>
    <description>Lunge lobectomy (total) Resection of esophagus cancer</description>
    <arm_group_label>Patients undergoing Thoracic Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for resection surgeries for either lung or esophagus cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled thoracic resection Surgery for lung- or esophagus cancer. For lung cancer&#xD;
             patients, at least one lung lobe has to scheduled for resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known Diaphragmatic Dysfunction&#xD;
&#xD;
          -  Neuromuscular Disease&#xD;
&#xD;
          -  Pleural Effusion &gt; 1cm&#xD;
&#xD;
          -  Pneumothorax&#xD;
&#xD;
          -  Known Phrenic Nerve Palsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anaesthesiology and Intensive Care East Section, Aarhus University Hospital</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Peter Juhl-Olsen</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paralysis</mesh_term>
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04507594
org study id: DiaphragmaticDysfunction
nct id: NCT04507594
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to measure diaphragmatic dysfunction with ultrasonography and nerve
      stimulation of the phrenicus nerve, in patients undergoing thoracic surgery for lung and
      esophageal cancer, and correlate measures of diaphramatic function to clinical postoperative
      endpoints.
observational model: Cohort
time perspective: Prospective
measure: Change in excursion of the diaphragm
time frame: Prior to surgery to 14 days after surgery
description: Ultrasonographic measure with M-mode of Diaphragmatic Excursion on right hemidiaphragm
measure: Ultrasonographic measure of the difference in Intrathoracic Area
time frame: Prior to surgery to 14 days after surgery
description: Intrathoracic Area is measured at inspiration and expiration to calculate the difference in Intrathoracic Area during breathing
measure: Change in Diaphragmatic Thickening Fraction
time frame: Prior to surgery to 14 days after surgery
description: Ultrasonographic measurement
measure: Change in Intercostal Muscle Thickening Fraction
time frame: Prior to surgery to 14 days after surgery
description: Ultrasonographic measurement
measure: Change in forced expired volume within the first second (FEV1)
time frame: Prior to surgery to 14 days after surgery
description: Spirometry
measure: Change in forced vital capacity (FEV)
time frame: Prior to surgery to 14 days after surgery
description: Spirometry
measure: Change in peak flow
time frame: Prior to surgery to 14 days after surgery
description: Spirometry
measure: Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nerve
time frame: Prior to surgery to 14 days after surgery
measure: Change in Electromyographic measure of Latency of Diaphragmatic Response after stimulating the phrenic nerve
time frame: Prior to surgery to 14 days after surgery
measure: Change in 6 Minutes Walk Test
time frame: Prior to surgery to 14 days after surgery
description: Maximum Walking Distance within 6 minutes
measure: Change in visual analogue scale score
time frame: Prior to surgery to 14 days after surgery
description: Scoring system for subjective sensation of pain ranging from 0 to 10. Higher numbers signify higher pain sensations
measure: Accumulated Opiod Use after Surgery
time frame: Prior to surgery to 14 days after surgery
description: Morphine equivalents
measure: Postoperative Pulmonary Complications
time frame: Prior to surgery to 30 days after surgery
description: Comprising:
Pneumonia
Atelectasis
Bronchospasm
Hypoxemia
Severe Hypoxemia
Pleural Effusion 1 > cm
Pneumothorax
CPAP or NIV required after 1. postoperative day
measure: Admission days at the Intensive Care Unit after Surgery
time frame: Prior to surgery to 60 days after surgery
measure: Number of Admissions after Discharge from the Surgical Department
time frame: Prior to surgery to 60 days after surgery
measure: Accumulated Admission Days at any Hospital
time frame: Prior to surgery to 60 days after surgery
arm group label: Patients undergoing Thoracic Surgery
intervention type: Procedure
intervention name: Lung lobectomy OR esophagus cancer resection
description: Lunge lobectomy (total) Resection of esophagus cancer
arm group label: Patients undergoing Thoracic Surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Peter Juhl-Olsen
investigator title: Associate Professor
mesh term: Paralysis
mesh term: Postoperative Complications
sharing ipd: Undecided