<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/NCT02214394</url>
  </required_header>
  <id_info>
    <org_study_id>20121475-00087006</org_study_id>
    <secondary_id>1R43GM090469-01A1</secondary_id>
    <nct_id>NCT02214394</nct_id>
  </id_info>
  <brief_title>Detection of Propofol in Exhaled Breath</brief_title>
  <official_title>Propofol in Exhaled Breath: Real-time Detection by Surface Acoustic Wave Sensors.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xhale Assurance</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of General Medical Sciences (NIGMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Xhale Assurance</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study involves the use of an experimental device which will measure how much propofol is&#xD;
      present in your exhaled breath during surgery compared to how much is in your blood. The&#xD;
      study results will look at whether the device is as accurate as conventional methods for&#xD;
      measuring propofol levels during surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">October 2014</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of propofol concentrations in exhaled breath to those in plasma</measure>
    <time_frame>Sampling will occur every 2 minutes after anesthetic induction up to 10 minutes and then every 5 minutes thereafter up to 1 hour.</time_frame>
    <description>Measure and compare propofol concentrations in exhaled breath to those in plasma in human patients anesthetized with propofol. Samples of the exhaled breath from patients will be monitored using the SAW Sensor and collected onto Tenax TA Tubes for analysis by Thermal Desorption GC/MS (using the method described by Grossher et al.)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be given Propofol during routine surgery and then using the SMART Device the breath will be captured and compared to blood plasma using High-performance liquid chromatography Analysis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-performance liquid chromatography Analysis</intervention_name>
    <description>Blood samples will be collected for HPLC analysis to compare with the breath samples.</description>
    <arm_group_label>Propofol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SMART Device</intervention_name>
    <description>Breath collection for GC-MS analysis to compare with Blood collection.</description>
    <arm_group_label>Propofol</arm_group_label>
    <other_name>SMART Breath Based Monitor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be between 18 and 65 years old&#xD;
&#xD;
          -  Healthy Male or Female&#xD;
&#xD;
          -  BMI between 18.5 and 30.0&#xD;
&#xD;
          -  Have a planned surgery or other medical procedure requiring anesthesia&#xD;
&#xD;
          -  Physical status ASA I, II, or III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to any component of propofol formulation components&#xD;
&#xD;
          -  History of lung disease or tobacco use in the past 5 years&#xD;
&#xD;
          -  Any finding not detailed above encountered on medical history or during screening&#xD;
             physical and clinical laboratory examinations that, in the investigators judgment,&#xD;
             might place the subject at unacceptable risk for injury during study participation&#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>Donn M Dennis, M.D., F.A.H.A.</last_name>
    <role>Study Director</role>
    <affiliation>Xhale, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Donn Dennis, MD</last_name>
    <phone>352-371-8488</phone>
  </overall_contact>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Judith Wishin, RN, BSN, CCRC</last_name>
      <email>jwishin@anest.ufl.edu</email>
    </contact>
    <investigator>
      <last_name>Timothy E Morey, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT02214394
org study id: 20121475-00087006
secondary id: 1R43GM090469-01A1
nct id: NCT02214394
lead sponsor: 
collaborator: 
has dmc: No
This study involves the use of an experimental device which will measure how much propofol is
      present in your exhaled breath during surgery compared to how much is in your blood. The
      study results will look at whether the device is as accurate as conventional methods for
      measuring propofol levels during surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Comparison of propofol concentrations in exhaled breath to those in plasma
time frame: Sampling will occur every 2 minutes after anesthetic induction up to 10 minutes and then every 5 minutes thereafter up to 1 hour.
description: Measure and compare propofol concentrations in exhaled breath to those in plasma in human patients anesthetized with propofol. Samples of the exhaled breath from patients will be monitored using the SAW Sensor and collected onto Tenax TA Tubes for analysis by Thermal Desorption GC/MS (using the method described by Grossher et al.)
arm group label: Propofol
arm group type: Experimental
description: Subjects will be given Propofol during routine surgery and then using the SMART Device the breath will be captured and compared to blood plasma using High-performance liquid chromatography Analysis.
intervention type: Other
intervention name: High-performance liquid chromatography Analysis
description: Blood samples will be collected for HPLC analysis to compare with the breath samples.
arm group label: Propofol
intervention type: Device
intervention name: SMART Device
description: Breath collection for GC-MS analysis to compare with Blood collection.
arm group label: Propofol
other name: SMART Breath Based Monitor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Donn M Dennis, M.D., F.A.H.A.
role: Study Director
affiliation: Xhale, Inc.
last name: Donn Dennis, MD
phone: 352-371-8488
facility: 
contact: 
investigator: 
country: United States
responsible party type: Sponsor