<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/NCT03038061</url>
  </required_header>
  <id_info>
    <org_study_id>NVT108-8/104-2015/ÚVN</org_study_id>
    <nct_id>NCT03038061</nct_id>
  </id_info>
  <brief_title>Ultrasound Detection of Position of Diaphragm During Laparoscopic Surgery</brief_title>
  <acronym>UDLaS</acronym>
  <official_title>Ultrasound Detection of Presence of Diaphragm in the Region of Lung Monitoring Using Electrical Impedance Tomography During Laparoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Czech Technical University in Prague</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Military University Hospital, Prague</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Czech Technical University in Prague</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>
      Position of diaphragm in the region of electrical impedance tomography measurement is to be&#xD;
      determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to&#xD;
      be obtained at three phases at supine horizontal position (during spontaneous breathing, at&#xD;
      mechanically ventilated patient under general anesthesia with muscle relaxation and at&#xD;
      mechanically ventilated patient under general anesthesia with muscle relaxation during&#xD;
      insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during&#xD;
      laparoscopic surgery).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During laparoscopic surgery, insufflation of carbon dioxide into the peritoneal cavity is&#xD;
      conducted in order to optimize working space for surgeons. As a side effect, the abdominal&#xD;
      pressure alters physiological thoraco-abdominal configuration and pushes the diaphragm and&#xD;
      lungs cranially. Since lung image acquired by electrical impedance tomography (EIT) depends&#xD;
      on the conditions within the thorax and abdomen, it is crucial to know the diaphragm position&#xD;
      to analyze the effect of cranial shift of diaphragm on EIT images of the thorax. Presence of&#xD;
      diaphragm in the region of EIT measurement is to be determined by ultrasound in approx. 20&#xD;
      patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine&#xD;
      horizontal position (during spontaneous breathing, at mechanically ventilated patient under&#xD;
      general anesthesia with muscle relaxation and at mechanically ventilated patient under&#xD;
      general anesthesia with muscle relaxation during insufflation of carbon dioxide into the&#xD;
      peritoneal cavity to achieve exposure during laparoscopic surgery). The results of this study&#xD;
      will serve during design of a subsequent study dealing with optimization of EIT electrode&#xD;
      belt position during laparoscopic surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2015</start_date>
  <completion_date type="Actual">February 24, 2021</completion_date>
  <primary_completion_date type="Actual">February 24, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single group assignment. Approx. 20 patients during laparoscopic surgery with capnoperitoneum.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Position of Diaphragm Detected by Ultrasound</measure>
    <time_frame>Within one laparoscopic surgery (1-3 hours)</time_frame>
    <description>Measurement in midclavicular line</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Laparoscopy</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing Laparoscopic Surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patients undergoing Laparoscopic Surgery</intervention_name>
    <description>Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery).</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - patients undergoing abdominal laparoscopic surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  morbid obesity&#xD;
&#xD;
          -  standard exclusion criteria for electrical impedance tomography according to the&#xD;
             manufacturer&#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>Karel Roubik, Prof. Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Czech Technical University in Prague</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martin Müller</last_name>
    <role>Principal Investigator</role>
    <affiliation>Czech Technical University in Prague / Military University Hospital, Prague</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Military University Hospital</name>
      <address>
        <city>Prague</city>
        <zip>16902</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <reference>
    <citation>Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. doi: 10.1016/j.bpa.2010.02.002.</citation>
    <PMID>20608559</PMID>
  </reference>
  <reference>
    <citation>Staehr-Rye AK, Rasmussen LS, Rosenberg J, Steen-Hansen C, Nielsen TF, Rosenstock CV, Clausen HV, Sorensen MK, VON H Regeur J, Gatke MR. Minimal impairment in pulmonary function following laparoscopic surgery. Acta Anaesthesiol Scand. 2014 Feb;58(2):198-205. doi: 10.1111/aas.12254. Epub 2014 Jan 2.</citation>
    <PMID>24383568</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 28, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>February 24, 2021</last_update_submitted>
  <last_update_submitted_qc>February 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diaphragm</keyword>
  <keyword>EIT</keyword>
  <keyword>Laparoscopy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>http://ventilation.fbmi.cvut.cz/wp-content/uploads/2017/01/Informed-Consent-Form.pdf</doc_url>
      <doc_comment>Informed Consent</doc_comment>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03038061
org study id: NVT108-8/104-2015/ÚVN
nct id: NCT03038061
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Position of diaphragm in the region of electrical impedance tomography measurement is to be
      determined by ultrasound in approx. 20 patients undergoing laparoscopic surgery. Data are to
      be obtained at three phases at supine horizontal position (during spontaneous breathing, at
      mechanically ventilated patient under general anesthesia with muscle relaxation and at
      mechanically ventilated patient under general anesthesia with muscle relaxation during
      insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during
      laparoscopic surgery).
During laparoscopic surgery, insufflation of carbon dioxide into the peritoneal cavity is
      conducted in order to optimize working space for surgeons. As a side effect, the abdominal
      pressure alters physiological thoraco-abdominal configuration and pushes the diaphragm and
      lungs cranially. Since lung image acquired by electrical impedance tomography (EIT) depends
      on the conditions within the thorax and abdomen, it is crucial to know the diaphragm position
      to analyze the effect of cranial shift of diaphragm on EIT images of the thorax. Presence of
      diaphragm in the region of EIT measurement is to be determined by ultrasound in approx. 20
      patients undergoing laparoscopic surgery. Data are to be obtained at three phases at supine
      horizontal position (during spontaneous breathing, at mechanically ventilated patient under
      general anesthesia with muscle relaxation and at mechanically ventilated patient under
      general anesthesia with muscle relaxation during insufflation of carbon dioxide into the
      peritoneal cavity to achieve exposure during laparoscopic surgery). The results of this study
      will serve during design of a subsequent study dealing with optimization of EIT electrode
      belt position during laparoscopic surgery.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single group assignment. Approx. 20 patients during laparoscopic surgery with capnoperitoneum.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Position of Diaphragm Detected by Ultrasound
time frame: Within one laparoscopic surgery (1-3 hours)
description: Measurement in midclavicular line
arm group label: Experimental group
arm group type: Experimental
description: Patients undergoing Laparoscopic Surgery
intervention type: Other
intervention name: Patients undergoing Laparoscopic Surgery
description: Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery).
arm group label: Experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karel Roubik, Prof. Ph.D.
role: Study Director
affiliation: Czech Technical University in Prague
last name: Martin Müller
role: Principal Investigator
affiliation: Czech Technical University in Prague / Military University Hospital, Prague
facility: 
country: Czechia
country: Czech Republic
citation: Valenza F, Chevallard G, Fossali T, Salice V, Pizzocri M, Gattinoni L. Management of mechanical ventilation during laparoscopic surgery. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):227-41. doi: 10.1016/j.bpa.2010.02.002.
PMID: 20608559
citation: Staehr-Rye AK, Rasmussen LS, Rosenberg J, Steen-Hansen C, Nielsen TF, Rosenstock CV, Clausen HV, Sorensen MK, VON H Regeur J, Gatke MR. Minimal impairment in pulmonary function following laparoscopic surgery. Acta Anaesthesiol Scand. 2014 Feb;58(2):198-205. doi: 10.1111/aas.12254. Epub 2014 Jan 2.
PMID: 24383568
responsible party type: Sponsor
sharing ipd: No
study doc: 