<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/NCT01671098</url>
  </required_header>
  <id_info>
    <org_study_id>06301998</org_study_id>
    <nct_id>NCT01671098</nct_id>
  </id_info>
  <brief_title>Sinonasal Gas Exchange Dynamics</brief_title>
  <official_title>Sinonasal Gas Exchange Dynamics The Aerodynamic Theory of the Sinonasal Interface</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Louisiana State University Health Sciences Center Shreveport</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Louisiana State University Health Sciences Center Shreveport</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sinonasal gas exchange is facilitated by the unique anatomy and topography of the sinonasal&#xD;
      interface that represents a collection of airfoils creating an aerodynamic structure. The&#xD;
      airflow during respiration generates positive and negative pressures that power the gas&#xD;
      exchange between the sinuses and the nose. Major surgical alteration of the interface reduces&#xD;
      the rate and velocity of the exchange. Minimally invasive procedures aimed at preserving the&#xD;
      natural anatomy, topography and aerodynamic configuration of the interface will have&#xD;
      negligible effects on sinonasal gas exchange.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</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>Sinonasal gas exchange rate</measure>
    <time_frame>2 years</time_frame>
    <description>ANALYZE AND DEFINE GAS EXCHANGE PATTERNS IN THE MAXILLARY SINUS DURING NASAL RESPIRATION IN NORMAL SINUSES AND COMPARE WITH SURGICALLY MODIFIED SUBJECTS THAT WILL INCLUDE MAXILLARY SINUSES AFTER ENDOSCOPIC SINUS SURGERY AND BALLOON SINUPLASTY.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NO production rate</measure>
    <time_frame>2 years</time_frame>
    <description>ANALYZE AND DEFINE NITRIC OXIDE PRODUCTION RATE AND VARIABLES IN NORMAL AND SURGICALLY ALTERED MAXILLARY SINUSES</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Sinusitis</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Healthy adults</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Balloon Sinuplasty</arm_group_label>
    <description>Patients who had balloon sinuplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FESS-Uncinectomy</arm_group_label>
    <description>Patients who had FESS-Uncinectomy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients who had balloon sinuplasty of traditional endoscopic uncinectomy for&#xD;
        treatment of chronic maxillary sinusitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Control:&#xD;
&#xD;
               -  normal healthy adult volunteers ages 18-65,&#xD;
&#xD;
          -  without allergies by history and allergy test,&#xD;
&#xD;
          -  non-smoker,&#xD;
&#xD;
          -  not using steroids. Study group 1: adult subjects who had maxillary sinus balloon&#xD;
             sinuplasty (with intact uncinate and ethmoid complex) Study group 2: adult subjects&#xD;
             who had endoscopic maxillary antrostomy and uncinectomy.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  active acute or chronic infection,&#xD;
&#xD;
          -  nasal polyps,&#xD;
&#xD;
          -  severe nasal or septal deformity,&#xD;
&#xD;
          -  cystic fibrosis,&#xD;
&#xD;
          -  systemic illness (diabetes, hypertension etc.),&#xD;
&#xD;
          -  vulnerable population (children, pregnant women, institutionalized individuals etc.)&#xD;
&#xD;
          -  severe nasal and/or septal deviation,&#xD;
&#xD;
          -  hypersensitivity or intolerance to study medications (topical and local anesthetics)&#xD;
             any turbinate surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anil A Gungor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Louisiana State University Health Sciences Center in New Orleans</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LSU Health ACC</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>August 18, 2015</last_update_submitted>
  <last_update_submitted_qc>August 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Louisiana State University Health Sciences Center Shreveport</investigator_affiliation>
    <investigator_full_name>Anil Gungor MD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>nitric oxide</keyword>
  <keyword>sinuplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01671098
org study id: 06301998
nct id: NCT01671098
lead sponsor: 
has dmc: No
Sinonasal gas exchange is facilitated by the unique anatomy and topography of the sinonasal
      interface that represents a collection of airfoils creating an aerodynamic structure. The
      airflow during respiration generates positive and negative pressures that power the gas
      exchange between the sinuses and the nose. Major surgical alteration of the interface reduces
      the rate and velocity of the exchange. Minimally invasive procedures aimed at preserving the
      natural anatomy, topography and aerodynamic configuration of the interface will have
      negligible effects on sinonasal gas exchange.
observational model: Case-Only
time perspective: Prospective
measure: Sinonasal gas exchange rate
time frame: 2 years
description: ANALYZE AND DEFINE GAS EXCHANGE PATTERNS IN THE MAXILLARY SINUS DURING NASAL RESPIRATION IN NORMAL SINUSES AND COMPARE WITH SURGICALLY MODIFIED SUBJECTS THAT WILL INCLUDE MAXILLARY SINUSES AFTER ENDOSCOPIC SINUS SURGERY AND BALLOON SINUPLASTY.
measure: NO production rate
time frame: 2 years
description: ANALYZE AND DEFINE NITRIC OXIDE PRODUCTION RATE AND VARIABLES IN NORMAL AND SURGICALLY ALTERED MAXILLARY SINUSES
arm group label: Control
description: Healthy adults
arm group label: Balloon Sinuplasty
description: Patients who had balloon sinuplasty
arm group label: FESS-Uncinectomy
description: Patients who had FESS-Uncinectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anil A Gungor, MD
role: Principal Investigator
affiliation: Louisiana State University Health Sciences Center in New Orleans
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Louisiana State University Health Sciences Center Shreveport
investigator full name: Anil Gungor MD
investigator title: Associate Professor
mesh term: Sinusitis