<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/NCT04400370</url>
  </required_header>
  <id_info>
    <org_study_id>diaphragm_US</org_study_id>
    <nct_id>NCT04400370</nct_id>
  </id_info>
  <brief_title>Point of Care Ultrasound to Evaluate Diaphragmatic Function in Children Undergoing Thoracic Surgery</brief_title>
  <official_title>Point of Care Ultrasound to Evaluate Diaphragmatic Function in Children Undergoing Thoracic Surgery: Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In children undergoing pulmonary resection, the diaphragm function is evaluated using&#xD;
      ultrasound before and after surgery to evaluate the incidence of diaphragm dysfunction after&#xD;
      pulmonary resection. In addition, we examine if there is a relationship between diaphragmatic&#xD;
      dysfunction and pulmonary complications, including postoperative lung atelectasis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 8, 2020</start_date>
  <completion_date type="Actual">May 1, 2022</completion_date>
  <primary_completion_date type="Actual">May 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in diaphragmatic thickness</measure>
    <time_frame>1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery</time_frame>
    <description>Changes in diaphragmatic thickness, from time frame 1 to 3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in diaphragm thickening fraction</measure>
    <time_frame>1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery</time_frame>
    <description>Changes in diaphragm thickening fraction, from time frame 1 to 3</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in the length of diaphragmatic tidal excursion</measure>
    <time_frame>1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery</time_frame>
    <description>Changes in the length of diaphragmatic tidal excursion, from time frame 1 to 3</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">75</enrollment>
  <condition>Diaphragm Dysfunction</condition>
  <arm_group>
    <arm_group_label>Pediatric patients undergoing lung resection</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Diaphragm ultrasound</intervention_name>
    <description>Diaphragm ultrasound is performed at the following three time points.&#xD;
At the entrance of the operating room before induction of anesthesia&#xD;
1 hour after surgery&#xD;
24 hours after surgery</description>
    <arm_group_label>Pediatric patients undergoing lung resection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients under 7 years undergoing lung resection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients under 7 years undergoing lung resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Myopathy or neuropathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Jin-Tae Kim</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 6, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin-Tae Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04400370
org study id: diaphragm_US
nct id: NCT04400370
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In children undergoing pulmonary resection, the diaphragm function is evaluated using
      ultrasound before and after surgery to evaluate the incidence of diaphragm dysfunction after
      pulmonary resection. In addition, we examine if there is a relationship between diaphragmatic
      dysfunction and pulmonary complications, including postoperative lung atelectasis.
observational model: Case-Only
time perspective: Prospective
measure: Changes in diaphragmatic thickness
time frame: 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery
description: Changes in diaphragmatic thickness, from time frame 1 to 3
measure: Changes in diaphragm thickening fraction
time frame: 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery
description: Changes in diaphragm thickening fraction, from time frame 1 to 3
measure: Changes in the length of diaphragmatic tidal excursion
time frame: 1. Before the procedure; 2. 1 hour after surgery; 3. 24 hours after surgery
description: Changes in the length of diaphragmatic tidal excursion, from time frame 1 to 3
arm group label: Pediatric patients undergoing lung resection
intervention type: Device
intervention name: Diaphragm ultrasound
description: Diaphragm ultrasound is performed at the following three time points.
At the entrance of the operating room before induction of anesthesia
1 hour after surgery
24 hours after surgery
arm group label: Pediatric patients undergoing lung resection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Years
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin-Tae Kim
investigator title: Professor