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Detection of Propofol in Exhaled Breath

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ClinicalTrials.gov Identifier: NCT02214394
Recruitment Status : Unknown
Verified August 2014 by Xhale Assurance.
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Xhale Assurance

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Other: High-performance liquid chromatography Analysis Device: SMART Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Propofol in Exhaled Breath: Real-time Detection by Surface Acoustic Wave Sensors.
Study Start Date : August 2014
Estimated Primary Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
Experimental: Propofol
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.
Other: High-performance liquid chromatography Analysis
Blood samples will be collected for HPLC analysis to compare with the breath samples.

Device: SMART Device
Breath collection for GC-MS analysis to compare with Blood collection.
Other Name: SMART Breath Based Monitor




Primary Outcome Measures :
  1. 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. ]
    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.)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be between 18 and 65 years old
  • Healthy Male or Female
  • BMI between 18.5 and 30.0
  • Have a planned surgery or other medical procedure requiring anesthesia
  • Physical status ASA I, II, or III

Exclusion Criteria:

  • Known allergy to any component of propofol formulation components
  • History of lung disease or tobacco use in the past 5 years
  • Any finding not detailed above encountered on medical history or during screening physical and clinical laboratory examinations that, in the investigators judgment, might place the subject at unacceptable risk for injury during study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214394


Contacts
Contact: Donn Dennis, MD 352-371-8488

Locations
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32608
Contact: Judith Wishin, RN, BSN, CCRC       jwishin@anest.ufl.edu   
Principal Investigator: Timothy E Morey, MD         
Sponsors and Collaborators
Xhale Assurance
National Institute of General Medical Sciences (NIGMS)
Investigators
Study Director: Donn M Dennis, M.D., F.A.H.A. Xhale, Inc.

Responsible Party: Xhale Assurance
ClinicalTrials.gov Identifier: NCT02214394     History of Changes
Other Study ID Numbers: 20121475-00087006
1R43GM090469-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics